Heart Failure Activity Coach Study (HEALTHY)

October 23, 2023 updated by: CareLigo AB

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Eskilstuna, Sweden, 63188
        • Skiftinge VC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
A sham activity coach will be installed on the Optilogg system, slightly changing its appearance.
Other: sham activity coach
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.
Experimental: Intervention
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study design
Time Frame: 12 weeks
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
Time Frame: 12 weeks
Measured with acelerometer, reported as steps per day
12 weeks
Sedentary time
Time Frame: 12 weeks
Measured with accelerometer, evaluate if sedentary time has been decreased by 10 minutes or more.
12 weeks
Goal attainment score
Time Frame: 12 weeks
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
Time Frame: 12 weeks
Health-related quality of life assessed by Kansas City Cardiomyopathy Questionnaire, a scale between 0 (very poor) to 100 (excellent).
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
System adherence
Time Frame: 12 weeks
For the intervention group, analysis of the frequency with which they used the activity coach
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CareLigo AB

Collaborators

Linkoeping University

Investigators

  • Principal Investigator: Tiny Jaarsma, PhD, Linkoeping University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Actual)

July 30, 2023

Study Completion (Actual)

September 1, 2023

Study Registration Dates

First Submitted

January 21, 2022

First Submitted That Met QC Criteria

February 1, 2022

First Posted (Actual)

February 11, 2022

Study Record Updates

Last Update Posted (Actual)

October 24, 2023

Last Update Submitted That Met QC Criteria

October 23, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • activity coach

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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