Therapeutic Benefit of Preventive Telehealth Counseling in the Community Outreach Heart Health and Risk Reduction Trial
2011; Elsevier BV; Volume: 107; Issue: 5 Linguagem: Inglês
10.1016/j.amjcard.2010.10.050
ISSN1879-1913
AutoresRobert P. Nolan, Ross Upshur, Hazel Lynn, Thomas Crichton, Ellen Rukholm, Donna E. Stewart, David A. Alter, Caroline Chessex, Paula J. Harvey, Sherry L. Grace, Louise Picard, Isabelle Michel, Jan Angus, Kim Corace, Susan M. Barry-Bianchi, Maggie H Chen,
Tópico(s)Physical Activity and Health
ResumoWe evaluated whether telehealth counseling augments lifestyle change and risk factor decrease in subjects at high risk for primary or secondary cardiovascular events compared to a recommended guideline for brief preventive counseling. Subjects at high risk or with coronary heart disease (35 to 74 years of age, n = 680) were randomized to active control (risk factor feedback, brief advice, handouts) or telehealth lifestyle counseling (active control plus 6 weekly 1-hour teleconferenced sessions to groups of 4 to 8 subjects). Primary outcome was questionnaire assessment of adherence to daily exercise/physical activity and diet (daily vegetable and fruit intake and restriction of fat and salt) after treatment and at 6-month follow-up. Secondary outcomes were systolic and diastolic blood pressures, ratio of total to high-density lipoprotein cholesterol, and 10-year absolute risk for coronary disease. After treatment and at 6-month follow-up, adherence increased for telehealth versus control in exercise (29.3% and 18.4% vs 2.5% and 9.3%, respectively, odds ratio 1.60, 95% confidence interval 1.2 to 2.1) and diet (37.1% and 38.1% vs 16.7% and 33.3%, respectively, odds ratio 1.41, 95% confidence interval 1.1 to 1.9). Telehealth versus control had greater 6-month decreases in blood pressure (mean ± SE, systolic −4.8 ± 0.8 vs −2.8 ± 0.9 mm Hg, p = 0.04; diastolic −2.7 ± 0.5 vs −1.5 ± 0.6 mm Hg, p = 0.04). Decreases in cholesterol ratio and 10-year absolute risk were significant for the 2 groups. In conclusion, telehealth counseling augments therapeutic lifestyle change in subjects at high risk for cardiovascular events compared to a recommended guideline for brief preventive counseling. We evaluated whether telehealth counseling augments lifestyle change and risk factor decrease in subjects at high risk for primary or secondary cardiovascular events compared to a recommended guideline for brief preventive counseling. Subjects at high risk or with coronary heart disease (35 to 74 years of age, n = 680) were randomized to active control (risk factor feedback, brief advice, handouts) or telehealth lifestyle counseling (active control plus 6 weekly 1-hour teleconferenced sessions to groups of 4 to 8 subjects). Primary outcome was questionnaire assessment of adherence to daily exercise/physical activity and diet (daily vegetable and fruit intake and restriction of fat and salt) after treatment and at 6-month follow-up. Secondary outcomes were systolic and diastolic blood pressures, ratio of total to high-density lipoprotein cholesterol, and 10-year absolute risk for coronary disease. After treatment and at 6-month follow-up, adherence increased for telehealth versus control in exercise (29.3% and 18.4% vs 2.5% and 9.3%, respectively, odds ratio 1.60, 95% confidence interval 1.2 to 2.1) and diet (37.1% and 38.1% vs 16.7% and 33.3%, respectively, odds ratio 1.41, 95% confidence interval 1.1 to 1.9). Telehealth versus control had greater 6-month decreases in blood pressure (mean ± SE, systolic −4.8 ± 0.8 vs −2.8 ± 0.9 mm Hg, p = 0.04; diastolic −2.7 ± 0.5 vs −1.5 ± 0.6 mm Hg, p = 0.04). Decreases in cholesterol ratio and 10-year absolute risk were significant for the 2 groups. In conclusion, telehealth counseling augments therapeutic lifestyle change in subjects at high risk for cardiovascular events compared to a recommended guideline for brief preventive counseling. The primary aim of this clinical trial was to evaluate whether a telehealth protocol that used motivational interviewing1Miller W.R. Rollnick S. Motivational Interviewing: Preparing People for Change. Guilford Press, New York2002Google Scholar, 2Nolan R.P. The Community Outreach Heart Health and Risk Reduction Trial: Facilitator's Guide. University Health Network, Toronto, Ontario, Canada2002Google Scholar added therapeutic benefit for change in exercise, diet, or smoking in subjects at high risk for or with established cardiovascular disease. We used an active control intervention that represented a recommended guideline for brief preventive counseling.3Balady G.J. Williams M.A. Ades P.A. Bittner V. Comoss P. Foody J.A. Franklin B. Sanderson B. Southard D. Core components of cardiac rehabilitation/secondary prevention programs: 2007 update: a scientific statement from the American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee, the Council on Clinical Cardiology; the Councils on Cardiovascular Nursing, Epidemiology and Prevention, and Nutrition, Physical Activity, and Metabolism, and the American Association of Cardiovascular and Pulmonary Rehabilitation.J Cardiopulm Rehabil Prev. 2007; 27: 121-129Crossref PubMed Scopus (192) Google Scholar The extent to which telehealth augmented a decrease in cardiovascular risk factors after adjusting for medications was our secondary objective. Subjects were at high risk for a cardiovascular event; they were 35 to 74 years of age and had a diagnosis of coronary heart disease or diabetes, or Framingham 10-year absolute risk for coronary heart disease ≥20,4Grundy S.M. Pasternak R. Greenland P. Smith Jr, S. Fuster V. Assessment of cardiovascular risk by use of multiple-risk-factor assessment equations: a statement for healthcare professionals from the American Heart Association and the American College of Cardiology.Circulation. 1999; 100: 1481-1492Crossref PubMed Scopus (946) Google Scholar or ≥2 risk factors that included hypertension, dyslipidemia, smoking, or obesity (body mass index ≥30 kg/m2 or waist circumference >88 cm in women or >102 cm in men). Exclusion was based on psychiatric illness, alcohol or drug dependence in the previous year, or residence in an institutional setting. Medications were not altered by design. The Community Outreach Heart Health and Risk Reduction Trial (COHRT) was a 2 parallel-group, single-blind randomized controlled trial: active control versus telehealth counseling assessed at baseline, 2 weeks after treatment, and at 6-month follow-up. Subjects and their physicians were blinded to the research design. Research assistants providing the telehealth intervention had no involvement in outcome evaluations. Randomization was conducted by a computer program that stratified for gender, cardiovascular disease, diabetes, and depression (Beck Depression Inventory II ≥14).5Beck A.T. Steer R.A. Internal consistencies of the original and revised Beck Depression Inventory.J Clin Psychol. 1984; 40: 1365-1367Crossref PubMed Scopus (937) Google Scholar Randomization was blocked within our northern, rural, and urban recruitment sites in Ontario, Canada. A 2:3 sampling ratio was used for telehealth versus control groups to permit analysis of psychosocial determinants of lifestyle change (not reported in the present study). Randomization codes were concealed in opaque sealed envelopes that were sorted by stratification features. Approval was obtained from research ethics boards of each institution. Recruitment initiatives included presentations to family medicine departments and patient groups, random-digit dialing within targeted area codes, and newspaper advertisements. Recruits were screened by telephone interview. Eligible subjects were mailed an information package and a patient profile form, which requested family physicians to confirm diagnoses and cardiovascular risk factors. We provided a prepaid requisition for assays of 12-hour fasting lipoprotein cholesterol if these were not assessed within the previous 6 months. Eligible subjects were scheduled for assessment at a local COHRT clinic after receipt of fasting blood tests and physician confirmation of diagnoses and cardiovascular risk factors. Randomization to telehealth versus control followed informed consent during the initial COHRT clinic visit. COHRT clinics were held in family medicine outpatient clinics and a behavioral cardiology research unit in 2 tertiary care hospitals (urban site) and collaborating family medicine practices and offices of 2 public health units (rural and northern sites) in Ontario, Canada. COHRT clinics were scheduled between 8:00 a.m. and 12:00 p.m. Subjects were instructed to refrain from smoking and strenuous exercise for ≥4 hours before their appointment. Baseline measurements were taken by trained research assistants for height, weight, body mass index, waist circumference, and blood pressure (2 measurements, 30 minutes apart). Blood assays of 12-hour fasting cholesterol (total, high-density lipoprotein, total/high-density lipoprotein ratio, and low-density lipoprotein) were obtained for the COHRT clinic visit. Procedures for assaying blood samples were standardized across sites using a common laboratory network. Low-density lipoprotein cholesterol was calculated using the Friedewald formula when triglycerides were <4.52 mmol/L (400 mg/dl). The Framingham 10-year absolute risk index4Grundy S.M. Pasternak R. Greenland P. Smith Jr, S. Fuster V. Assessment of cardiovascular risk by use of multiple-risk-factor assessment equations: a statement for healthcare professionals from the American Heart Association and the American College of Cardiology.Circulation. 1999; 100: 1481-1492Crossref PubMed Scopus (946) Google Scholar was estimated for subjects without established cardiovascular disease. Baseline exercise, diet, and smoking were measured by questionnaire6Prochaska J.O. Velicer W.F. Rossi J.S. Goldstein M.G. Marcus B.H. Rakowski W. Fiore C. Harlow L.L. Redding C.A. Rosenbloom D. Stages of change and decisional balance for 12 problem behaviors.Health Psychol. 1994; 13: 39-46Crossref PubMed Scopus (1909) Google Scholar (Table 1). At 2 weeks after treatment, this questionnaire was administered by telephone. However, the 6-month follow-up assessment was conducted during a COHRT clinic visit that replicated the baseline protocol: anthropometric measurements, cardiovascular risk factors (with fasting blood assays obtained within 2 weeks of the visit), and questionnaires.Table 1Lifestyle assessment at baseline, after treatment, and at six-month follow-upCategoryItem⁎Each questionnaire item was scaled by the transtheoretical model12: Precontemplation (not adhering to the target behavior and not ready to change within 6 months), contemplation (not adhering to the target behavior but ready to change within 6 months), preparation (not adhering to the target behavior but ready to change within 1 month), action (adhering to the target behavior for <6 months), and maintenance (adhering to the target behavior for ≥6 months).ContentExercisePlanned exerciseI do a planned exercise for ≥20 minutes, 3–5 times/week (e.g., brisk walking, aerobics, jogging, swimming, skiing).Daily activityI keep active in my daily habits 5–6 days/week (e.g., walking and climbing stairs at home and work, cutting grass, shoveling snow, washing floors).DietVegetablesI eat 3–5 servings of vegetables each day (1/2 cup of raw or cooked vegetables is 1 serving).FruitI eat 2–4 servings of fruit each day (1 piece of fruit, such as an apple, is 1 serving).Fat intakeAt each meal, I eat <30% of calories from fat by eating lean meat without the skin and avoiding fried foods (e.g., French fries) and high-fat comfort foods such as potato chips.Sodium intakeAt each meal, I avoid adding extra salt to my food, and I avoid eating salty foods such as chips, soy sauce, fast foods such as hamburgers, and prepared food mixes.Smoking cessationI have a smoke-free lifestyle everyday, which does not include even 1 puff of a cigarette. Each questionnaire item was scaled by the transtheoretical model12Glanz K. Patterson R.E. Kristal A.R. DiClemente C.C. Heimendinger J. Linnan L. McLerran D.F. Stages of change in adopting healthy diets: fat, fiber, and correlates of nutrient intake.Health Educ Q. 1994; 21: 499-519Crossref PubMed Scopus (224) Google Scholar: Precontemplation (not adhering to the target behavior and not ready to change within 6 months), contemplation (not adhering to the target behavior but ready to change within 6 months), preparation (not adhering to the target behavior but ready to change within 1 month), action (adhering to the target behavior for <6 months), and maintenance (adhering to the target behavior for ≥6 months). Open table in a new tab Antihypertensive medications (angiotensin-converting enzyme inhibitors, calcium channel blockers, diuretics, β blockers, α-adrenergic blockers, or angiotensin II receptor blockers) or lipid-lowering agents were recorded at baseline and 6-month follow-up. Change in dosage or type of medications was coded for the baseline to 6-month follow-up interval. During the initial COHRT clinic visit, controls received a 10-minute intervention that included a review and written summary of their cardiovascular risk factor profiles. Subjects without established cardiovascular disease were given their Framingham 10-year absolute risk score. Brief advice for therapeutic change in exercise, diet, and smoking was provided with accompanying educational handouts7Health CanadaCanada Food Guide to Healthy Eating. Health Canada, Ottawa, Ontario, Canada1997Google Scholar, 8Health CanadaCanada's Physical Activity Guide to Healthy Active Living.in: Health Canada, Ottawa, Ontario, Canada1998Google Scholar, 9Canadian Council on Smoking and HealthYour Guide to a Smoke Free Future.in: Canadian Council on Smoking and Health, Ottawa, Ontario, Canada1996Google Scholar and a list of community programs for lifestyle change. The profile of each subject's cardiovascular risk factors, 10-year absolute risk,4Grundy S.M. Pasternak R. Greenland P. Smith Jr, S. Fuster V. Assessment of cardiovascular risk by use of multiple-risk-factor assessment equations: a statement for healthcare professionals from the American Heart Association and the American College of Cardiology.Circulation. 1999; 100: 1481-1492Crossref PubMed Scopus (946) Google Scholar and severity of depressive symptoms5Beck A.T. Steer R.A. Internal consistencies of the original and revised Beck Depression Inventory.J Clin Psychol. 1984; 40: 1365-1367Crossref PubMed Scopus (937) Google Scholar was mailed to their family physician. The telehealth group received this intervention plus 6 weekly 1-hour sessions of lifestyle counseling by teleconference to small groups (n = 4 to 8). Subjects were matched according to a fixed schedule of weekly sessions. Access to each telehealth session was made by a toll-free number and a private access code. The protocol for telehealth sessions was standardized with a COHRT treatment manual2Nolan R.P. The Community Outreach Heart Health and Risk Reduction Trial: Facilitator's Guide. University Health Network, Toronto, Ontario, Canada2002Google Scholar that was a group-based application of motivational interviewing.1Miller W.R. Rollnick S. Motivational Interviewing: Preparing People for Change. Guilford Press, New York2002Google Scholar Subjects identified their priority for lifestyle change (diet, exercise, or smoking) and they were taught to self-assess their stage of readiness for change: precontemplation, contemplation, preparation, action, and maintenance.6Prochaska J.O. Velicer W.F. Rossi J.S. Goldstein M.G. Marcus B.H. Rakowski W. Fiore C. Harlow L.L. Redding C.A. Rosenbloom D. Stages of change and decisional balance for 12 problem behaviors.Health Psychol. 1994; 13: 39-46Crossref PubMed Scopus (1909) Google Scholar Across sessions, stage-matched strategies to support lifestyle change were introduced and supported with take-home projects. Motivational interviewing guidelines were used to focus group discussion on (1) salient lifestyle goals identified by subjects, (2) progress in resolving ambivalence about lifestyle change, and (3) experiences of increased efficacy in initiating or maintaining change. Group facilitators included 2 public health nurses, 6 allied health professionals, and 8 PhD students in clinical psychology who completed a 3- to 4-day training program (with R.P.N.).2Nolan R.P. The Community Outreach Heart Health and Risk Reduction Trial: Facilitator's Guide. University Health Network, Toronto, Ontario, Canada2002Google Scholar Quality control of this intervention was maintained by weekly supervision by teleconference (with R.P.N. or K.C.). Primary outcomes were defined as adherence to Health Canada guidelines7Health CanadaCanada Food Guide to Healthy Eating. Health Canada, Ottawa, Ontario, Canada1997Google Scholar, 8Health CanadaCanada's Physical Activity Guide to Healthy Active Living.in: Health Canada, Ottawa, Ontario, Canada1998Google Scholar for exercise (planned weekly exercise or daily activity), diet (daily intake of vegetables and fruit, and daily restriction of fat and salt), and smoke-free living (Table 1). As in previous trials,10Steptoe A. Kerry S. Rink E. Hilton S. The impact of behavioral counseling on stage of change in fat intake, physical activity, and cigarette smoking in adults at increased risk of coronary heart disease.Am J Public Health. 2001; 91: 265-269Crossref PubMed Scopus (145) Google Scholar adherence to each of these behaviors was defined by self-reported criteria for the action or maintenance stages of readiness for change.6Prochaska J.O. Velicer W.F. Rossi J.S. Goldstein M.G. Marcus B.H. Rakowski W. Fiore C. Harlow L.L. Redding C.A. Rosenbloom D. Stages of change and decisional balance for 12 problem behaviors.Health Psychol. 1994; 13: 39-46Crossref PubMed Scopus (1909) Google Scholar Questionnaire items for exercise and diet were previously validated according to grade of energy expenditure,11Plotnikoff R.C. Hotz S.B. Birkett N.J. Courneya K.S. Exercise and the transtheoretical model: a longitudinal test of a population sample.Prev Med. 2001; 33: 441-452Crossref PubMed Scopus (140) Google Scholar food frequency questionnaires,12Glanz K. Patterson R.E. Kristal A.R. DiClemente C.C. Heimendinger J. Linnan L. McLerran D.F. Stages of change in adopting healthy diets: fat, fiber, and correlates of nutrient intake.Health Educ Q. 1994; 21: 499-519Crossref PubMed Scopus (224) Google Scholar, 13Kristal A.R. Glanz K. Curry S.J. Patterson R.E. How can stages of change be best used in dietary interventions?.J Am Diet Assoc. 1999; 99: 679-684Abstract Full Text Full Text PDF PubMed Scopus (128) Google Scholar and by body mass index and waist circumference.12Glanz K. Patterson R.E. Kristal A.R. DiClemente C.C. Heimendinger J. Linnan L. McLerran D.F. Stages of change in adopting healthy diets: fat, fiber, and correlates of nutrient intake.Health Educ Q. 1994; 21: 499-519Crossref PubMed Scopus (224) Google Scholar, 14Logue E. Sutton K. Jarjoura D. Smucker W. Obesity management in primary care: assessment of readiness to change among 284 family practice patients.J Am Board Fam Pract. 2000; 13: 164-171Crossref PubMed Scopus (38) Google Scholar Secondary outcomes at 6-month follow-up included risk factors (systolic and diastolic blood pressures, total/high-density lipoprotein cholesterol) and the Framingham index of 10-year absolute risk for coronary heart disease.4Grundy S.M. Pasternak R. Greenland P. Smith Jr, S. Fuster V. Assessment of cardiovascular risk by use of multiple-risk-factor assessment equations: a statement for healthcare professionals from the American Heart Association and the American College of Cardiology.Circulation. 1999; 100: 1481-1492Crossref PubMed Scopus (946) Google Scholar Criterion validity of self-reported adherence versus nonadherence to exercise and diet at baseline and 6-month follow-up was measured by body mass index, weight decrease, and Health Canada guidelines for active living15Beland Y. Canadian community health survey—methodological overview.Health Rep. 2002; 13: 9-14PubMed Google Scholar using analysis of variance and Pearson chi-square test. Baseline characteristics of telehealth subjects versus controls were evaluated with analysis of variance and Pearson chi-square test. Generalized estimation equations assessed whether a larger proportion of telehealth versus control subjects adhered to exercise and diet after treatment and at 6-month follow-up, controlling for baseline adherence to exercise and diet, age, gender, body mass index, and interval (after treatment and 6-month follow-up). Multivariable linear regression analyses evaluated whether telehealth versus control subjects had greater decreases at 6-month follow-up in systolic and diastolic blood pressures and total/high-density lipoprotein cholesterol adjusted for baseline values of each variable, age, gender, body mass index, antihypertensive or lipid-lowering medications at baseline, and change in antihypertensive or lipid-lowering medications up to 6-month follow-up. This regression model also assessed group differences in decrease of the Framingham index of 10-year absolute risk in subjects without cardiovascular disease. COHRT was powered to detect increased adherence at 4-month follow-up after lifestyle counseling10Steptoe A. Kerry S. Rink E. Hilton S. The impact of behavioral counseling on stage of change in fat intake, physical activity, and cigarette smoking in adults at increased risk of coronary heart disease.Am J Public Health. 2001; 91: 265-269Crossref PubMed Scopus (145) Google Scholar to the action/maintenance stage of readiness for change6Prochaska J.O. Velicer W.F. Rossi J.S. Goldstein M.G. Marcus B.H. Rakowski W. Fiore C. Harlow L.L. Redding C.A. Rosenbloom D. Stages of change and decisional balance for 12 problem behaviors.Health Psychol. 1994; 13: 39-46Crossref PubMed Scopus (1909) Google Scholar in dietary fat decrease (odds ratio 2.15, 95% confidence interval 1.3 to 3.6) and physical activity (odds ratio 1.89, 95% confidence interval 1.1 to 3.4) with 80% power, 5% type 1 error rate, and 25% attrition. This estimate used the method of Wang et al16Wang H. Chow S.C. Li G. On sample size calculation based on odds ratio in clinical trials.J Biopharm Stat. 2002; 12: 471-483Crossref PubMed Scopus (31) Google Scholar to account for a 2:3 sampling ratio for telehealth versus control. Analyses were performed using the intention-to-treat approach. Missing data were managed by multiple imputations using the Markov chain Monte Carlo method. Outcomes were similar across 5 imputations and each was consistent with the raw data. Statistical significance was defined by 2-tailed tests with a p value <0.05. Analyses were conducted with SAS 9.1 (SAS Institute, Cary, North Carolina). The sample included 267 controls and 413 telehealth subjects (Figure 1). Withdrawals did not differ significantly between groups (controls, n = 30, 11.2%; telehealth subjects, n = 32, 7.7%, p = 0.12). Table 2 presents baseline characteristics. Antihypertensive or lipid-lowering drugs were prescribed to 80% of subjects. There was a high prevalence of change in antihypertensive or lipid-lowering medications from baseline to 6-month follow-up (controls, n = 113, 42.3%; telehealth subjects, n = 171, 41.4%, p = 0.74; Appendix 1, available on-line).Table 2Baseline characteristicsVariablesActive Control (n = 267)Telehealth (n = 413)p ValueAge (years)58.61 ± 0.5359.27 ± 0.430.34Women132 (49.4%)202 (48.9%)0.89Income groups (<$20,000 = 1, ≥$70,000 = 7)4.91 ± 0.134.50 ± 0.100.02Body mass index (kg/m2)30.58 ± 0.3831.60 ± 0.330.047Waist circumference (>88 cm in women, >102 cm in men)188 (70.4%)321 (77.7%)0.03Hypertension182 (68.2%)300 (72.6%)0.21Dyslipidemia181 (67.8%)286 (69.2%)0.69Diabetes mellitus138 (51.7%)216 (52.3%)0.88Smoker40 (15.0%)53 (12.8%)0.43Coronary heart disease risk status0.38 ≥2 cardiovascular risk factors⁎Select cardiovascular risk factors include hypertension, dyslipidemia, smoking, or obesity.69 (25.8%)97 (23.5%) Absolute 10-year coronary heart disease risk10Steptoe A. Kerry S. Rink E. Hilton S. The impact of behavioral counseling on stage of change in fat intake, physical activity, and cigarette smoking in adults at increased risk of coronary heart disease.Am J Public Health. 2001; 91: 265-269Crossref PubMed Scopus (145) Google Scholar ≥20 or diabetes132 (49.45%)194 (47.0%) Coronary heart disease66 (24.75%)122 (29.55%)Medications β Blocker73 (27.3%)114 (27.6%)0.94 Calcium channel blocker56 (21.0%)94 (22.8%)0.58 Angiotensin-converting enzyme inhibitor94 (35.2%)156 (37.8%)0.50 Angiotensin II receptor blocker32 (12.0%)50 (12.1%)0.96 α-Receptor blocker1 (0.4%)4 (0.6%)0.38 Diuretic75 (28.1%)111 (26.9%)0.73 Lipid-lowering agent137 (51.3%)217 (52.5%)0.75 ≥1 antihypertensive drug†Antihypertensive medications include β blockers, calcium channel blockers, angiotensin-converting enzyme inhibitors, α-adrenergic blockers, angiotensin II receptor blockers, or diuretics.187 (70.0%)298 (72.2%)0.55 ≥1 antihypertensive or lipid-lowering drug212 (79.4%)332 (80.4%)0.75Systolic blood pressure (mm Hg)128.39 ± 0.97131.30 ± 0.780.02Diastolic blood pressure (mm Hg)77.02 ± 0.5677.48 ± 0.450.52Total/high-density lipoprotein cholesterol (mmol/L)‡To convert to milligrams per deciliter, multiply by 38.67.4.42 ± 0.094.35 ± 0.070.58Total lipoprotein cholesterol (mmol/L)‡To convert to milligrams per deciliter, multiply by 38.67.5.21 ± 0.095.30 ± 0.070.45High-density lipoprotein cholesterol (mmol/L)‡To convert to milligrams per deciliter, multiply by 38.67.1.26 ± 0.031.29 ± 0.020.48Low-density lipoprotein cholesterol (mmol/L)‡To convert to milligrams per deciliter, multiply by 38.67.3.05 ± 0.073.03 ± 0.050.78Data are presented as mean ± SE or number of subjects (percentage). Select cardiovascular risk factors include hypertension, dyslipidemia, smoking, or obesity.† Antihypertensive medications include β blockers, calcium channel blockers, angiotensin-converting enzyme inhibitors, α-adrenergic blockers, angiotensin II receptor blockers, or diuretics.‡ To convert to milligrams per deciliter, multiply by 38.67. Open table in a new tab Data are presented as mean ± SE or number of subjects (percentage). Criterion validity for questionnaires assessing adherence to diet and exercise was supported by corroborating physiologic data. Subjects who reported baseline adherence versus nonadherence to diet had a lower body mass index (30.1 ± 0.39 vs 31.8 ± 0.32 kg/m2, respectively, p <0.001). Body mass index was also lower in subjects who reported adherence versus nonadherence to exercise (30.1 ± 0.29 vs 32.7 ± 0.43 kg/m2, respectively, p <0.001). Weight loss from baseline to 6-month follow-up (assessed in COHRT clinics) was greater in subjects who reported adherence versus nonadherence to exercise (−l.56 ± 0.61 vs 0.96 ± 0.88 lb, respectively, p = 0.02) or to diet (−1.96 ± 0.70 vs 0.52 ± 0.71 lb, respectively, p = 0.01). Subjects reporting adherence to exercise at baseline were more likely to meet conventional criteria for active living as assessed by screening items obtained from the Canadian Community Health Survey15Beland Y. Canadian community health survey—methodological overview.Health Rep. 2002; 13: 9-14PubMed Google Scholar (Appendix 2, available online). The most prevalent self-selected goals for lifestyle change were exercise (n = 284, 41.8%) and diet (n = 280, 41.2%) or a combination of exercise and diet (n = 59, 8.7%). Smoking cessation was the sole primary goal for change for only 1 subject. At 6-month follow-up, smoking cessation was observed for 3 of 40 controls (7.5%) and 5 of 53 telehealth subjects (9.4%). Hence, additional analyses are not presented. A larger proportion of telehealth subjects versus controls reported adherence to exercise and diet after treatment and at 6-month follow-up as observed for unadjusted outcomes (Table 3) and after adjustment for covariates (Table 4). All risk factors decreased significantly for telehealth subjects and controls at 6-month follow-up (Table 5). Telehealth subjects demonstrated greater decreases in systolic and diastolic blood pressures but not total/high-density lipoprotein cholesterol or 10-year absolute risk of coronary heart disease (Table 6).Table 3Unadjusted adherence to exercise and diet for active control and telehealthVariablesAfter Treatment6-Month Follow-UpAdherence to exercise⁎Defined as planned exercise ≥20 minutes, 3 to 5 times per week, or active daily habits 5 to 6 days per week. Active control (baseline, n = 161)165 (2.5%)176 (9.3%) Telehealth (baseline, n = 239)309 (29.3%)283 (18.4%)Adherence to diet†Defined as daily intake of vegetables (3 to 5 servings per day) and fruit (2 to 4 servings per day) and restriction of fat (<30% of daily calories) and salt (no extra salt at meals and avoidance of prepared foods and salty snacks). Active control (baseline, n = 132)154 (16.7%)176 (33.3%) Telehealth (baseline, n = 197)270 (37.1%)272 (38.1%)Data are presented as number of subjects (percent change). Defined as planned exercise ≥20 minutes, 3 to 5 times per week, or active daily habits 5 to 6 days per week.† Defined as daily intake of vegetables (3 to 5 servings per day) and fruit (2 to 4 servings per day) and restriction of fat (<30% of daily calories) and salt (no extra salt at meals and avoidance of prepared foods and salty snacks). Open table in a new tab Table 4Generalized estimating equation models of subjects in adherence to exercise and diet after treatment and at six-month follow-upVariablesOdds Ratio95% Confidence Intervalp ValueAdherence to exercise⁎Nonadherence = 0 and adherence = 1 for adherence to exercise or diet at baseline, after treatment, and at 6-month follow-up. Baseline exercise: nonadherence versus adherence4.773.59–6.32<0.0001 Age1.010.99–1.030.29 Gender†Women = 0, men = 1.1.170.88–1.560.28 Body mass index0.970.95–0.990.001 Interval: after treatment versus 6-month follow-up‡After treatment = 1, 6-month follow-up = 2.1.130.92–1.400.28 Intervention: active control versus telehealth1.601.20–2.120.0009Adherence to diet⁎Nonadherence = 0 and adherence = 1 for adherence to exercise or diet at baseline, after treatment, and at 6-month follow-up. Baseline diet: nonadherence versus adherence5.123.82–6.86<0.0001 Age1.041.02–1.06<0.0001 Gender†Women = 0, men = 1.1.461.11–1.920.007 Body mass index0.990.97–1.020.65 Interval: after treatment versus 6-month follow-up‡After treatment = 1, 6-month follow-up = 2.0.560.46–0.68<0.0001 Intervention: active control versus telehealth1.311.09–1.480.012 Nonadherence = 0 and adherence = 1 for adherence to exercise or diet at baseline, after treatment, and at 6-month follow-up.† Women = 0, men = 1.‡ After treatment = 1, 6-month follow-up = 2. Open table in a new tab Table 5Unadjusted change in cardiovascular risk indexes for active control and telehealth groupsVariablesBaseline6-Month Follow-UpChangep Value for ChangeSystolic blood pressure (mm Hg) Active control128.39 ± 0.93125.55 ± 0.93−2.84 ± 0.870.001 Telehealth131.30 ± 0.80126.47 ± 0.75−4.83 ± 0.75<0.0001Diastolic blood pressure (mm Hg) Active control77.02 ± 0.5375.53 ± 0.58−1.49 ± 0.600.01 Telehealth77.48 ± 0.4774.75 ± 0.49−2.73 ± 0.46<0.0001Total/high-density lipoprotein cholesterol Active control4.42 ± 0.093.95 ± 0.08−0.47 ± 0.08<0.0001 Telehealth4.39 ± 0.034.07 ± 0.07−0.32 ± 0.07<0.0001Framingham index of 10-year absolute risk⁎Absolute 10-year risk in subjects without coronary heart disease. Active control12.83 ± 0.2811.06 ± 0.45−1.77 ± 0.45<0.0001 Telehealth13.73 ± 0.1912.61 ± 0.34−1.12 ± 0.390.005Data are presented as mean ± SE. Absolute 10-year risk in subjects without coronary heart disease. Open table in a new tab Table 6Multivariable linear regression models of change in cardiovascular risk factors at 6-month follow-upβ95% CIp ValueSystolic blood pressure (mm Hg) Baseline systolic blood pressure−14.70−17.27, −12.13<.0001 Age−0.05−0.16, 0.070.40 Sex0.20−1.94, 2.340.85 Body mass index0.240.06, 0.420.006 Antihypertensive medications at baseline⁎Antihypertensive medications as in Table 2.0.19−2.01, 2.390.87 Change in antihypertensive medications†Change in antihypertensive or lipid lowering medications: 0 = no change or not prescribed, 1 = change.−3.62−5.89, −1.350.002 Interventions: Control vs. Telehealth−2.09−4.09, −0.090.04Diastolic blood pressure (mm Hg) Baseline diastolic blood pressure−9.36−11.87, −6.85<.0001 Age−0.10−0.18, −0.020.03 Sex−1.39−2.78, 0.0020.05 Body mass index0.150.03, 0.270.01 Antihypertensive medications at baseline⁎Antihypertensive medications as in Table 2.0.66−0.81, 2.130.38 Change in antihypertensive medications†Change in antihypertensive or lipid lowering medications: 0 = no change or not prescribed, 1 = change.−1.94−3.41, −0.470.009 Interventions: Control vs. Telehealth−1.39−2.72, −0.060.04Total/High-Density Cholesterol Baseline total/high-density cholesterol−0.79−0.99, −0.59<.0001 Age0.020.0004, 0.040.02 Sex−0.04−0.24, 0.160.65 Body mass index0.01−0.01, 0.030.16 Lipid lowering medications at baseline⁎Antihypertensive medications as in Table 2.−0.08−0.28, 0.120.44 Change in lipid lowering medications†Change in antihypertensive or lipid lowering medications: 0 = no change or not prescribed, 1 = change.−0.35−0.59, −0.110.004 Interventions: Control vs. Telehealth0.13−0.07, 0.330.18Framingham Index of 10-Year Absolute Risk‡Absolute 10-year risk among subjects without coronary heart disease. Baseline 10-year absolute risk−5.74−7.15, −4.33<.0001 Age0.05−0.009, 0.110.16 Sex−0.79−2.02, 0.440.21 Body mass index0.06−0.06, 0.180.30 Antihypertensive medications at baseline⁎Antihypertensive medications as in Table 2.−0.08−1.47, 1.310.91 Change in antihypertensive medications†Change in antihypertensive or lipid lowering medications: 0 = no change or not prescribed, 1 = change.−0.68−2.09, 0.730.35 Lipid lowering medications at baseline⁎Antihypertensive medications as in Table 2.−0.13−1.31, 1.050.82 Change in lipid lowering medications†Change in antihypertensive or lipid lowering medications: 0 = no change or not prescribed, 1 = change.−0.94−2.31, 0.430.18 Interventions: Control vs. Telehealth0.65−0.53, 1.830.28Data for risk factor change = 6-month follow-up - baseline. Antihypertensive medications as in Table 2.† Change in antihypertensive or lipid lowering medications: 0 = no change or not prescribed, 1 = change.‡ Absolute 10-year risk among subjects without coronary heart disease. Open table in a new tab Data are presented as number of subjects (percent change). Data are presented as mean ± SE. Data for risk factor change = 6-month follow-up - baseline. We evaluated the efficacy of a telehealth intervention that used motivational interviewing in a group-based protocol that was standardized for session content and contact time with subjects.1Miller W.R. Rollnick S. Motivational Interviewing: Preparing People for Change. Guilford Press, New York2002Google Scholar, 2Nolan R.P. The Community Outreach Heart Health and Risk Reduction Trial: Facilitator's Guide. University Health Network, Toronto, Ontario, Canada2002Google Scholar The control intervention was also standardized for contact time with subjects and in its application of a recommended guideline for brief preventive counseling.3Balady G.J. Williams M.A. Ades P.A. Bittner V. Comoss P. Foody J.A. Franklin B. Sanderson B. Southard D. Core components of cardiac rehabilitation/secondary prevention programs: 2007 update: a scientific statement from the American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee, the Council on Clinical Cardiology; the Councils on Cardiovascular Nursing, Epidemiology and Prevention, and Nutrition, Physical Activity, and Metabolism, and the American Association of Cardiovascular and Pulmonary Rehabilitation.J Cardiopulm Rehabil Prev. 2007; 27: 121-129Crossref PubMed Scopus (192) Google Scholar The major finding of COHRT is that a larger proportion of telehealth subjects versus controls reported adherence to exercise and diet behaviors after treatment and at 6-month follow-up. This benefit was achieved after 6 weekly telehealth sessions. An important goal for future telehealth trials is to determine whether long-term adherence to preventive lifestyle behaviors can be sustained with intermittent booster sessions or with Internet-based support.17Wister A. Loewen N. Kennedy-Symonds H. McGowan B. McCoy B. Singer J. One-year follow-up of a therapeutic lifestyle intervention targeting cardiovascular disease risk.CMAJ. 2007; 177: 859-865Crossref PubMed Scopus (108) Google Scholar Systolic and diastolic blood pressures at 6-month follow-up were significantly improved with telehealth counseling. In contrast, total/high-density lipoprotein cholesterol and the Framingham 10-year absolute risk index were reduced for the telehealth and active control groups and the magnitude of improvement in these outcomes was consistent with previous trials.18Garcia-Lizana F. Sarria-Santamera A. New technologies for chronic disease management and control: a systematic review.J Telemed Telecare. 2007; 13: 62-68Crossref PubMed Scopus (99) Google Scholar, 19Neubeck L. Redfern J. Fernandez R. Briffa T. Bauman A. Freedman S.B. Telehealth interventions for the secondary prevention of coronary heart disease: a systematic review.Eur J Cardiovasc Prev Rehabil. 2009; 16: 281-289Crossref PubMed Scopus (189) Google Scholar It is unclear whether similar improvement in lipoprotein cholesterol and the Framingham absolute risk index would have been achieved with usual care combined with a behavioral placebo that provided nonspecific support. Meta-analysis19Neubeck L. Redfern J. Fernandez R. Briffa T. Bauman A. Freedman S.B. Telehealth interventions for the secondary prevention of coronary heart disease: a systematic review.Eur J Cardiovasc Prev Rehabil. 2009; 16: 281-289Crossref PubMed Scopus (189) Google Scholar has shown that compared to usual care, telehealth counseling significantly improved lipid profiles at 6- to 48-month follow-up in subjects with cardiovascular disease. Therefore, the failure to observe a similar therapeutic benefit for telehealth in COHRT may be due to use of (1) a shorter (6-month) follow-up assessment or (2) an active control intervention that provided risk factor information to subjects and their family physicians, which is known to facilitate a decrease in cardiovascular risk factors.20Grover S.A. Lowensteyn I. Joseph L. Kaouache M. Marchand S. Coupal L. Boudreau G. Patient knowledge of coronary risk profile improves the effectiveness of dyslipidemia therapy: the CHECK-UP study: a randomized controlled trial.Arch Intern Med. 2007; 167: 2296-2303Crossref PubMed Scopus (148) Google Scholar, 21Grover S.A. Lowensteyn I. Joseph L. Kaouache M. Marchand S. Coupal L. Boudreau G. Discussing coronary risk with patients to improve blood pressure treatment: secondary results from the CHECK-UP study.J Gen Intern Med. 2009; 24: 33-39Crossref PubMed Scopus (24) Google Scholar A large proportion of COHRT subjects (42%) reported a change in antihypertensive or lipid-lowering medications up to 6-month follow-up. We did not anticipate this outcome because subjects and their physicians were blinded to our research design. However, therapeutic adjustment in medications can be facilitated by providing patients with their cardiovascular risk profiles and by forwarding this information to their family physicians.20Grover S.A. Lowensteyn I. Joseph L. Kaouache M. Marchand S. Coupal L. Boudreau G. Patient knowledge of coronary risk profile improves the effectiveness of dyslipidemia therapy: the CHECK-UP study: a randomized controlled trial.Arch Intern Med. 2007; 167: 2296-2303Crossref PubMed Scopus (148) Google Scholar, 21Grover S.A. Lowensteyn I. Joseph L. Kaouache M. Marchand S. Coupal L. Boudreau G. Discussing coronary risk with patients to improve blood pressure treatment: secondary results from the CHECK-UP study.J Gen Intern Med. 2009; 24: 33-39Crossref PubMed Scopus (24) Google Scholar In addition, change in medications during COHRT was associated with a decrease in all cardiovascular risk factors (Table 6), but a similar association was not observed for baseline assessment of medications. Trials of preventive lifestyle counseling may overestimate the effect of behavior change on risk factor decrease when only baseline medications are factored into the outcome analysis. Several studies have noted that lifestyle counseling is provided to patients at a suboptimal level due to barriers such as constrained time and resources in patient care settings.22Castaldo J. Nester J. Wasser T. Masiado T. Rossi M. Young M. Napolitano J.J. Schwartz J.S. Physician attitudes regarding cardiovascular risk reduction: the gaps between clinical importance, knowledge, and effectiveness.Dis Manag. 2005; 8: 93-105Crossref PubMed Scopus (30) Google Scholar The telehealth protocol in COHRT was designed for administration to small groups (4 to 8 subjects) and it was provided by student trainees and allied health professionals. A group-based telehealth strategy merits consideration as a potential cost-efficient method to deliver preventive lifestyle counseling in settings where personnel resources are constrained. The findings of COHRT are limited to subjects who may require long-term access to an economical resource that can support therapeutic lifestyle change. Most subjects were at increased risk for an initial cardiovascular event. In contrast to many secondary prevention trials, our sample was balanced according to gender. The recruitment procedures may have attracted subjects with greater motivation to change their lifestyle behaviors. Nevertheless, telehealth was associated with improved lifestyle change compared to active controls. Behavioral outcomes were assessed by questionnaire. Future telehealth trials can improve upon this standard by using objective measurements of behavior change with accelerometry, food diaries, or 24-hour urine analysis of sodium excretion. Nevertheless, telehealth counseling may help extend the reach and efficacy of a recommended standard for brief preventive counseling3Balady G.J. Williams M.A. Ades P.A. Bittner V. Comoss P. Foody J.A. Franklin B. Sanderson B. Southard D. Core components of cardiac rehabilitation/secondary prevention programs: 2007 update: a scientific statement from the American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee, the Council on Clinical Cardiology; the Councils on Cardiovascular Nursing, Epidemiology and Prevention, and Nutrition, Physical Activity, and Metabolism, and the American Association of Cardiovascular and Pulmonary Rehabilitation.J Cardiopulm Rehabil Prev. 2007; 27: 121-129Crossref PubMed Scopus (192) Google Scholar in patients at high risk for primary or secondary cardiovascular events. The COHRT investigators extend sincere appreciation to the participants, collaborating organizations, students, and family physicians who made this trial possible. Download .doc (.05 MB) Help with doc files Appendix 1 and 2
Referência(s)