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A comparison of live counseling with a web-based lifestyle and medication intervention to reduce coronary heart disease risk: a randomized clinical trial.

ABSTRACT: Most primary care clinicians lack the skills and resources to offer effective lifestyle and medication (L&M) counseling to reduce coronary heart disease (CHD) risk. Thus, effective and feasible CHD prevention programs are needed for typical practice settings.To assess the effectiveness, acceptability, and cost-effectiveness of a combined L&M intervention to reduce CHD risk offered in counselor-delivered and web-based formats.A comparative effectiveness trial in 5 diverse family medicine practices in North Carolina. Participants were established patients, aged 35 to 79 years, with no known cardiovascular disease, and at moderate to high risk for CHD (10-year Framingham Risk Score [FRS], ?10%).Participants were randomized to counselor-delivered or web-based format, each including 4 intensive and 3 maintenance sessions. After randomization, both formats used a web-based decision aid showing potential CHD risk reduction associated with L&M risk-reducing strategies. Participants chose the risk-reducing strategies they wished to follow.The primary outcome was within-group change in FRS at 4-month follow-up. Other measures included standardized assessments of blood pressure, blood lipid levels, lifestyle behaviors, and medication adherence. Acceptability and cost-effectiveness were also assessed. Outcomes were assessed at 4 and 12 months.Of 2274 screened patients, 385 were randomized (192 counselor; 193 web): mean age, 62 years; 24% African American; and mean FRS, 16.9%. Follow-up at 4 and 12 months included 91% and 87% of the randomized participants, respectively. There was a sustained reduction in FRS at both 4 months (primary outcome) and 12 months for both counselor-based (-2.3% [95% CI, -3.0% to -1.6%] and -1.9% [95% CI, -2.8% to -1.1%], respectively) and web-based groups (-1.5% [95% CI, -2.2% to -0.9%] and -1.7% [95% CI, -2.6% to -0.8%] respectively). At 4 months, the adjusted difference in FRS between groups was -1.0% (95% CI, -1.8% to -0.1%) (P?=?.03), and at 12 months, it was -0.6% (95% CI, -1.7% to 0.5%) (P?=?.30). The 12-month costs from the payer perspective were $207 and $110 per person for the counselor- and web-based interventions, respectively.Both intervention formats reduced CHD risk through 12-month follow-up. The web format was less expensive.clinicaltrials.gov Identifier: NCT01245686.

SUBMITTER: Keyserling TC

PROVIDER: S-EPMC4142754 | biostudies-literature | 2014 Jul

REPOSITORIES: biostudies-literature

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A comparison of live counseling with a web-based lifestyle and medication intervention to reduce coronary heart disease risk: a randomized clinical trial.

Keyserling Thomas C TC Sheridan Stacey L SL Draeger Lindy B LB Finkelstein Eric A EA Gizlice Ziya Z Kruger Eliza E Johnston Larry F LF Sloane Philip D PD Samuel-Hodge Carmen C Evenson Kelly R KR Gross Myron D MD Donahue Katrina E KE Pignone Michael P MP Vu Maihan B MB Steinbacher Erika A EA Weiner Bryan J BJ Bangdiwala Shrikant I SI Ammerman Alice S AS

JAMA internal medicine 20140701 7

<h4>Importance</h4>Most primary care clinicians lack the skills and resources to offer effective lifestyle and medication (L&M) counseling to reduce coronary heart disease (CHD) risk. Thus, effective and feasible CHD prevention programs are needed for typical practice settings.<h4>Objective</h4>To assess the effectiveness, acceptability, and cost-effectiveness of a combined L&M intervention to reduce CHD risk offered in counselor-delivered and web-based formats.<h4>Design, setting, and participa ...[more]

PMID: 24861959

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Project description:BACKGROUND:Trials of complex interventions are often criticized for being difficult to interpret because the effects of apparently similar interventions vary across studies dependent on context, targeted groups, and the delivery of the intervention. The Motivational Interviewing and Medication Review in Coronary heart disease (MIMeRiC) trial is a randomized controlled trial (RCT) of an intervention aimed at improving pharmacological secondary prevention. Guidelines for the development and evaluation of complex interventions have recently highlighted the need for better reporting of the development of interventions, including descriptions of how the intervention is assumed to work, how this theory informed the process evaluation, and how the process evaluation relates to the outcome evaluation. OBJECTIVE:This paper aims to describe how the intervention was designed and developed. The aim of the process evaluation is to better understand how and why the intervention in the MIMeRiC trial was effective or not effective. METHODS:The research questions for evaluating the process are based on the conceptual model of change processes assumed in the intervention and will be analyzed by qualitative and quantitative methods. Quantitative data are used to evaluate the medication review in terms of drug-related problems, to describe how patients' beliefs about medicines are affected by the intervention, and to evaluate the quality of motivational interviewing. Qualitative data will be used to analyze whether patients experienced the intervention as intended, how cardiologists experienced the collaboration and intervention, and how the intervention affected patients' overall experience of care after coronary heart disease. RESULTS:The development and piloting of the intervention are described in relation to the theoretical framework. Data for the process evaluation will be collected until March 2018. Some process evaluation questions will be analyzed before, and others will be analyzed after the outcomes of the MIMeRiC RCT are known. CONCLUSIONS:This paper describes the framework for the design of the intervention tested in the MIMeRiC trial, development of the intervention from the pilot stage to the complete trial intervention, and the framework and methods for the process evaluation. Providing the protocol of the process evaluation allows prespecification of the processes that will be evaluated, because we hypothesize that they will determine the outcomes of the MIMeRiC trial. This protocol also constitutes a contribution to the new field of process evaluations as made explicit in health services research and clinical trials of complex interventions.

Project description:BackgroundThe treatment of many chronic illnesses involves long-term pharmaceutical therapy, but it is an ongoing challenge to find effective ways to improve medication adherence to promote good health outcomes. Cardioprotective medications can prevent the enlargement of harmful clots, cardiovascular symptoms, and poor therapeutic outcomes, such as uncontrolled high blood pressure and hyperlipidemia, for patients with coronary heart disease. Poor adherence to cardioprotective medications, however, has been reported as a global health concern among patients with coronary heart disease, and it is particularly a concern in China.ObjectiveThis study aimed to evaluate the efficacy of a mobile health (mHealth) intervention using 2 mobile apps to improve medication adherence and health outcomes.MethodsA randomized, placebo-controlled, 2-arm parallel study was conducted in a major university-affiliated medical center located in Chengdu, China. Participants were recruited by flyers and health care provider referrals. Each participant was observed for 90 days, including a 60-day period of mHealth intervention and a 30-day period of nonintervention follow-up. The study coordinator used WeChat and Message Express to send educational materials and reminders to take medication, respectively. Participants used WeChat to receive both the educational materials and reminders. Participants in the control group only received educational materials. This study received ethics approval from the Duke Health Institutional Review Board (Pro00073395) on May 5, 2018, and was approved by West China Hospital (20170331180037). Recruitment began on May 20, 2018. The pilot phase of this study was registered on June 8, 2016, and the current, larger-scale study was retrospectively registered on January 11, 2021 (ClinicalTrials.gov).ResultsWe recruited 230 patients with coronary heart disease. Of these patients, 196 completed the baseline survey and received the intervention. The majority of participants were married (181/196, 92.4%), male (157/196, 80.1%), and lived in urban China (161/196, 82.1%). Participants' average age was 61 years, and half were retired (103/191, 53.9%). More than half the participants (121/196, 61.7%) were prescribed at least 5 medications. The mean decrease in medication nonadherence score was statistically significant at both 60 days (t179=2.04, P=.04) and 90 days (t155=3.48, P<.001). Systolic blood pressure and diastolic blood pressure decreased in the experimental group but increased in the control group. The mean decrease in diastolic blood pressure was statistically significant at both 60 days (t160=2.07, P=.04) and 90 days (t164=2.21, P=.03). The mean decrease in systolic blood pressure was significantly different in the groups at 90 days (t165=3.12, P=.002).ConclusionsThe proposed mHealth intervention can improve medication adherence and health outcomes, including systolic blood pressure and diastolic blood pressure.Trial registrationClinicalTrials.gov NCT02793830; https://clinicaltrials.gov/ct2/show/NCT02793830 and ClinicalTrials.gov NCT04703439; https://clinicaltrials.gov/ct2/show/NCT04703439.

Dataset Information

A comparison of live counseling with a web-based lifestyle and medication intervention to reduce coronary heart disease risk: a randomized clinical trial.

Publications

A comparison of live counseling with a web-based lifestyle and medication intervention to reduce coronary heart disease risk: a randomized clinical trial.

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