Physical InactivityHEALTHYNCT05235763
Heart Failure Activity Coach Study
A study testing activity coach in people with Physical Inactivity and Heart Failure, run by CareLigo AB at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physical Inactivity, Heart Failure
- What is being tested?
- activity coach
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jun 2022to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed heart failure
- Equipped with Optilogg
- Physically inactive (screening)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Physical Inactivity, Heart Failure
- Being tested
- activity coach, sham activity coach
- Medical subject headings
- Sedentary Behavior, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
activity coachOther
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.
sham activity coachOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | A sham activity coach will be installed on the Optilogg system, slightly changing its appearance. Receives: Other: sham activity coach |
| Intervention | Experimental | 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. Receives: Other: activity coach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study design
Analyze the number of patients needed to be screened to find appropriate and willing participants for the study.
Measured: 12 weeks
Secondary outcomes (4)
Physical activity
Measured with acelerometer, reported as steps per day
Measured: 12 weeks
Sedentary time
Measured with accelerometer, evaluate if sedentary time has been decreased by 10 minutes or more.
Measured: 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.
Measured: 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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start1 Jun 2022
- Primary completion30 Jul 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- CareLigo AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Linkoeping University
- Responsible party
- Sponsor
- Investigators
- Tiny Jaarsma, PhD, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235763
- Sponsor's protocol ID
- activity coach
- Acronym
- HEALTHY
- Status last verified
- Oct 2023
- First submitted
- 21 Jan 2022
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32372549Blomqvist A, Back M, Klompstra L, Stromberg A, Jaarsma T. Testing the Recruitment Frequency, Implementation Fidelity, and Feasibility of Outcomes of the Heart Failure Activity Coach Study (HEALTHY): Pilot Randomized Controlled Trial. JMIR Form Res. 2025 Jan 8;9:e62910. doi: 10.2196/62910.
PubMed 39778202Blomqvist A, Back M, Klompstra L, Stromberg A, Jaarsma T. Usability and feasibility analysis of an mHealth-tool for supporting physical activity in people with heart failure. BMC Med Inform Decis Mak. 2024 Feb 12;24(1):44. doi: 10.1186/s12911-024-02452-z.
PubMed 38347499
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Failure Activity Coach Study
- ClinicalTrials.gov ID
- NCT05235763
- Acronym / sponsor ID
- HEALTHY / activity coach
- Conditions
- Physical Inactivity, Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- CareLigo ABIndustry (pharma, biotech, devices)
- Collaborators
- Linkoeping University
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 11 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: sham activity coachA sham activity coach will be installed on the Optilogg system, slightly changing its appearance. |
| Intervention | Experimental | Other: activity coachThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed heart failure
- Equipped with Optilogg
- Physically inactive (screening)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| activity coachThe 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 | Intervention |
| sham activity coachThe 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. | Other | Control |
Primary outcome
Study design
Time frame: 12 weeks
Analyze the number of patients needed to be screened to find appropriate and willing participants for the study.
4 secondary outcomes
Physical activity
Time frame: 12 weeks
Sedentary time
Time frame: 12 weeks
Goal attainment score
Time frame: 12 weeks
Kansas City Cardiomyopathy Questionnaire
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Background: PubMed 32372549Blomqvist 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.
- Derived from this study: PubMed 39778202Blomqvist A, Back M, Klompstra L, Stromberg A, Jaarsma T. Testing the Recruitment Frequency, Implementation Fidelity, and Feasibility of Outcomes of the Heart Failure Activity Coach Study (HEALTHY): Pilot Randomized Controlled Trial. JMIR Form Res. 2025 Jan 8;9:e62910. doi: 10.2196/62910.
- Derived from this study: PubMed 38347499Blomqvist A, Back M, Klompstra L, Stromberg A, Jaarsma T. Usability and feasibility analysis of an mHealth-tool for supporting physical activity in people with heart failure. BMC Med Inform Decis Mak. 2024 Feb 12;24(1):44. doi: 10.1186/s12911-024-02452-z.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiny Jaarsma, PhD principal investigator
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing activity coach in people with Physical Inactivity and Heart Failure, run by CareLigo AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study design (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05235763, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023.