NCT05235763

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 11, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

October 24, 2023

Status Verified

October 1, 2023

Enrollment Period

1.2 years

First QC Date

January 21, 2022

Last Update Submit

October 23, 2023

Conditions

Physical InactivityHeart Failure

Outcome Measures

Primary Outcomes (1)

  • Study design

    Analyze the number of patients needed to be screened to find appropriate and willing participants for the study.

    12 weeks

Secondary Outcomes (4)

  • Physical activity

    12 weeks

  • Sedentary time

    12 weeks

  • Goal attainment score

    12 weeks

  • Kansas City Cardiomyopathy Questionnaire

    12 weeks

Other Outcomes (1)

  • System adherence

    12 weeks

Study Arms (2)

Control

PLACEBO COMPARATOR

A sham activity coach will be installed on the Optilogg system, slightly changing its appearance.

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.

Other: activity coach

Interventions

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.

Intervention
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.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed heart failure
  • Equipped with Optilogg
  • Physically inactive (screening)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skiftinge VC

Eskilstuna, 63188, Sweden

Location

Related Publications (3)

  • 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.

    PMID: 32372549BACKGROUND

  • Blomqvist 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.

    PMID: 39778202DERIVED

  • Blomqvist 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.

    PMID: 38347499DERIVED

MeSH Terms

Conditions

Sedentary BehaviorHeart Failure

Condition Hierarchy (Ancestors)

BehaviorHeart DiseasesCardiovascular Diseases

Study Officials

  • Tiny Jaarsma, PhD

    Linkoeping University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Upon recruitment, patients are randomized 1:1 to either intervention or control group. The study arms run in parallell for the twelve weeks.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2022

First Posted

February 11, 2022

Study Start

June 1, 2022

Primary Completion

July 30, 2023

Study Completion

September 1, 2023

Last Updated

October 24, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)