Heart Failure Activity Coach Study

Study Overview
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Brief Summary
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An application (app) called the activity coach will be tested to see if it can increase physical activity and decrease sedentary behaviuor, as well as increase quality of life and lead to personal goal attainment in physically inactive heart failure (HF) patients. This pilot randomized controlled trial (RCT) will test the study design and recruitment process, as well as outcomes for a future efficacy RCT. HF-patients equipped with the mHealth-tool Optilogg will be screened for physical inactivity and then recruited and randomized to either have the activity coach app added to their Optilogg or remain with the standard Optilogg. The study will go on for 12 weeks. Weeks 1 and 12 physical activity using an accelerometer will be recorded, as well as health-related quality of life. At the start of the study the patients will list goals relating to physical activity which the wish to attain, and the level of attainment will be evaluated at the end of the study. The activity coach educated the patient about physical activity, offers means of manually tracking physical activity, and provides trends of registered activity. Furthermore, it provides weekly summaries of registered physical activity and provides means of setting goals for the following week.

Detailed Description
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Study design: ---------------- The activity coach is to be developed using a scientific approach based on the Medical Research Council guidelines, including a small pilot (ethical approval Dnr 2020-01444) which is to be published separately. This is the first step and the second step is the randomized controlled pilot study (pilot-RCT), to be performed in a primary care setting in Sweden (ethical approval Dnr 2021-05366-01). The purpose is to test the newly developed application (app) called the activity coach, to see if it can improve physical activity, health and quality of life in physically inactive hert failure (HF) patients, but more importantly test the study design and recruitment process, as well as outcomes for a future efficacy RCT. The patients included will already be equipped with the mHealth tool Optilogg, and then screened for physical inactivty through a self-report question (Blomqvist, 2020, ESC Heart Fail, Utility of single-item questions to assess physical inactivity in patients with chronic heart failure), and then randomized to either receive or not receive the activity coach app. After randomization the patients will be equipped with an accelerometer for one week. The intervention will go on for 12 weeks, and week twelve the patients will once again carry an acceleroemter. At baseline demographical data will be recorded, as well as data on co-morbidities and pharmacological treatment. Patients will from a pre-specified list select two goals relating to physical activity that they wish to attain. After 12 weeks they will evaluate the subjective goal attainment on a five level ordinal scale ranging from -2 to 2. At weeks 1 and 12 they will also report health related quality of life using the Kansas City Cardiomyopathy Questionnaire. Intervention --------------- The Optilogg system is based around a touch screen computer (tablet), and the activity coach app runs on this screen. During the first week the patient receives specific education about physical activity and HF on the screen After the first week the patient is expected to be motivated to engage in physical activity and a short slideshow on the screen of the activity coach illustrates how the person using the system can manually register physical activity on the tablet interface. The registered activity trends can be viewed on the screen.At the end of every week the user will receive a weekly summary on screen with the option to set a goal for next week. The goal functionality is optional so that anyone who feels negative stress from the goal, can simply select to not have a goal. All patients will have access to telephone support during office hours for technical assistance with Optilogg and/or the activity coach.

Official Title
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Heart Failure Activity Coach Study

Conditions
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Physical Inactivity, Heart Failure

Intervention / Treatment
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* Other: activity coach
* Other: sham activity coach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed heart failure Equipped with Optilogg Physically inactive (screening) Exclusion Criteria: Does not consent to using accelerometer Does not consent to home-visit Current participation in another study relating to physical activity Life-expectancy less than six months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Upon recruitment, patients are randomized 1:1 to either intervention or control group. The study arms run in parallell for the twelve weeks.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>A sham activity coach will be installed on the Optilogg system, slightly changing its appearance. | Other: sham activity coach<br>* The visual appearance of Optilogg is changed as to make the patient aware that something has happened to it, hence not knowing if it is the real activity coach or not. No new functionality is added, however.<br>|
| Experimental: Intervention<br>The activity coach educates the patient about physical activity, offers means of manually tracking physical activity, and provides trends of registered activity. Furthermore, it provides weekly summaries of registered physical activity and provides means of setting goals for the following week. | Other: activity coach<br>* The activity coach educates the patient about physical activity, offers means of manually tracking physical activity, and provides trends of registered activity. Furthermore, it provides weekly summaries of registered physical activity and provides means of setting goals for the following week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study design | Analyze the number of patients needed to be screened to find appropriate and willing participants for the study. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity | Measured with acelerometer, reported as steps per day | 12 weeks | 
| Sedentary time | Measured with accelerometer, evaluate if sedentary time has been decreased by 10 minutes or more. | 12 weeks | 
| Goal attainment score | At the start of the study, patients will select to goals relating to physical acitvity which they want to achieve. At the end of the study, this attainment will be evaluated on an ordinal scale with five levels, ranging from -2 to 2, and a mean of the two goal attainments is calculated. | 12 weeks | 
| Kansas City Cardiomyopathy Questionnaire | Health-related quality of life assessed by Kansas City Cardiomyopathy Questionnaire, a scale between 0 (very poor) to 100 (excellent). | 12 weeks |