Clinical trial NCT05235763: Heart Failure Activity Coach Study
Official title: Heart Failure Activity Coach Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Inactivity
Heart Failure
Lead sponsor: CareLigo AB
Sponsor class: INDUSTRY
Collaborators: name: Linkoeping University
First posted: 2022-02-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Study design
timeFrame: 12 weeks
Secondary outcomes:
measure: Physical activity
timeFrame: 12 weeks
measure: Sedentary time
timeFrame: 12 weeks
measure: Goal attainment score
timeFrame: 12 weeks
measure: Kansas City Cardiomyopathy Questionnaire
timeFrame: 12 weeks
Other outcomes:
measure: System adherence
timeFrame: 12 weeks
Locations:
city: Eskilstuna
country: Sweden
facility: Skiftinge VC
Study officials:
affiliation: Linkoeping University
name: Tiny Jaarsma, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blomqvist A, Back M, Klompstra L, Stromberg A, Jaarsma T. Utility of single-item questions to assess physical inactivity in patients with chronic heart failure. ESC Heart Fail. 2020 Aug;7(4):1467-1476. doi: 10.1002/ehf2.12709. Epub 2020 May 6.