Abstract
BackgroundCardiac rehabilitation (CR) programs are evidence-based and widely recommended. However, benefits from CR are likely lost among individuals who discontinue their regular exercise routines and healthy habits. One possible approach to enhance adherence to lifestyle advice after completion of CR, may be individualized follow-up enabled by a smartphone application (app).MethodsA protocol of a single-blinded, pragmatic randomized controlled trial. The study will take place in the eastern part of Norway, and will include heart patients who have completed CR. Participants will be recruited from two CR centers. Based on power calculation, 113 participants will be included. The intervention group will receive individualized follow-up through an app on a weekly basis throughout a year. The app will be set up with the participant’s own goals, and the follow-up will be based on these individual goals. The control group will receive usual care, including general advice regarding physical activity, exercise and diet. The participants will be assessed at baseline (at completion of CR) and 12 months after baseline. Primary outcome of the study will be peak oxygen uptake. Secondary outcomes include exercise performance, quality of life, health status, health literacy, self-perceived goal achievement, exercise habits, body weight, blood pressure as well as lipids and triglycerides.DiscussionTo our knowledge, this will be the first study to examine the effects of individualized follow-up with an app for one year, in patients completing CR. Hence, it is reasonable to assume that the study may be groundbreaking. Due to the large sample size and the theoretically based intervention, the study has the potential to generate new knowledge that may improve the design of future technology-based follow-up interventions of patients that have completed rehabilitation.Trial registrationClinicalTrials.gov. NCT03174106. First registration, 19/05/2017.
Highlights
Cardiac rehabilitation (CR) programs are evidence-based and widely recommended
The evaluation of feasibility was assessed through recruitment rate, adherence to the app including satisfaction with the technology, resource requirements and efficacy regarding capability to detect a change in quality of life (QoL) and health status questionnaires, and in perceived goal achievement
To allow for a 20% dropout, we aim at including 113 participants. To our knowledge, this will be the first study to examine the effects of one-year individualized follow-up with an app after completed CR, aiming to promote adherence to lifestyle advice
Summary
Study design The study is a single-blinded, pragmatic RCT comparing an intervention group with a control group. A supervisor will guide each participant in setting individual goals by using elements from motivational interview. As a part of the baseline assessment, the researcher will guide each participant in setting individual goals by using elements from motivational interview. They will be encouraged to maintain or improve their current physical activity level, exercise habits and/ or a heart healthy diet, depending on their own goals and needs. Participants will be encouraged to take fasting blood samples at their general practitioner at inclusion to the study and at follow-up They are asked to bring the results to baseline and the 12 months assessment. To allow for a 20% dropout, we aim at including 113 participants
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