Clinical trial NCT05011994: Maintenance of Physical Activity After Cardiac Rehabilitation
Official title: Maintenance of Physical Activity After Cardiac Rehabilitation: a Feasibility Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Heart Failure
Arrythmia
Heart Arrest
Keywords: cardiac rehabilitation
ischemic heart disease
Lead sponsor: Slagelse Hospital
Sponsor class: OTHER
Collaborators: name: City of Slagelse (municipality)
name: Holbaek Sygehus
name: University of Southern Denmark
name: University College Copenhagen
First posted: 2021-08-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Physical activity is a key element in cardiac rehabilitation and prevention of cardiovascular mortality and hospitalizations. After cardiac rehabilitation programs end, physical activity levels and participation in continued cardiac rehabilitation declines. The aim of this study is to evaluate the feasibility a mobile health intervention with text messages and behavior change theory in patients with cardiovascular disease for a duration of 3 months after completion of a cardiac rehabilitation program. An intervention consisting of action planning, text messages, and coordinator support is tested in a feasibility trial design with 40 expected participants.

Detailed description: Physical activity is a key element in cardiac rehabilitation and prevention of cardiovascular mortality and hospitalizations. After cardiac rehabilitation programs end, physical activity levels and participation in continued cardiac rehabilitation declines.

The primary aim of this study is to evaluate the feasibility in terms of recruitment, retention, data completeness, intervention delivery and compliance, and acceptability of a mobile health intervention with text messages and behavior change theory in patients with cardiovascular disease for a duration of 3 months after completion of a cardiac rehabilitation program.

The study is a single-group multi-site feasibility trial. Participants will be recruited from phase II cardiac rehabilitation programs at Slagelse Hospital, the city of Slagelse (municipality), and Holbæk Hospital. Starting immediately after completion of cardiac rehabilitation, study participants will receive an intervention that consists of action planning, text messages, and coordinator support for a period of 12 weeks (see more details under 'Arms and Interventions'). The investigators base the intervention on a theoretical model of behavior change in the form of the Health Action Process Approach (HAPA). Behavior change techniques (BCTs) are used as part of the intervention. The intervention is an addition to standard practice and does not replace any existing treatment offers.

To evaluate the feasibility of the intervention and its readiness to be tested in a subsequent RCT design, the investigators have set progression criteria using a system of green (proceed to RCT), amber (amend when proceeding to RCT), or red (issue must be solved before proceeding to RCT). The progression criteria are listed under 'Primary Outcome Measures'.

Participants will wear accelerometers on thigh and wrist for 1 and 3 weeks, respectively, starting 1 week before end of cardiac rehabilitation. Baseline measurements and start of intervention is planned to be at the same time as cardiac rehabilitation ends. After 11 weeks of intervention, participants will attend a follow-up assessment, where participants will wear accelerometers on thigh and wrist again.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years.
* Participant in an exercise-based cardiac rehabilitation program in either hospital or municipality setting.
* Access to a personal mobile phone and Danish telephone number.
* Able to walk 3 meters without assistance.

Exclusion Criteria:

* Insufficient Danish language proficiency to read and understand text messages and questionnaires.
* Patients cognitively or mentally unable to participate.
* Terminal patients and patients with a life expectancy of less than 3 months.

Primary outcomes:
measure: Recruitment
timeFrame: Baseline
measure: Attrition/retention through follow-up assessment session
timeFrame: Up to 12 weeks
measure: Accelerometer data completeness
timeFrame: Baseline
measure: Accelerometer data completeness
timeFrame: 12 weeks
measure: Response rate on patient reported outcomes
timeFrame: Baseline
measure: Response rate on patient reported outcomes
timeFrame: 12 weeks
measure: Coordinator time spent, minutes per participant throughout the intervention
timeFrame: 12 weeks
measure: Response rate (adherence) to weekly follow-up messages
timeFrame: 12 weeks
measure: Acceptability of text message component, single item
timeFrame: 12 weeks
Secondary outcomes:
measure: Physical activity, objectively measured
timeFrame: Change from baseline to 12 weeks
measure: Physical function, walking
timeFrame: Change from baseline to 12 weeks
measure: Physical function, sit-to-stand
timeFrame: Change from baseline to 12 weeks
measure: Physical activity, subjectively measured
timeFrame: Change from baseline to 12 weeks
Other outcomes:
measure: Health-related quality of life, general
timeFrame: Change from baseline to 12 weeks
measure: Health-related quality of life, VAS subscale
timeFrame: Change from baseline to 12 weeks
measure: Health-related quality of life, heart-specific
timeFrame: Change from baseline to 12 weeks
measure: Anxiety and depression
timeFrame: Change from baseline to 12 weeks
measure: Physical function, self-reported
timeFrame: Change from baseline to 12 weeks
measure: Comorbidity
timeFrame: Change from baseline to 12 weeks
measure: Self-efficacy, managing chronic disease
timeFrame: Change from baseline to 12 weeks
measure: Motivational Self-efficacy
timeFrame: Change from baseline to 12 weeks
measure: Coping Self-efficacy
timeFrame: Change from baseline to 12 weeks
measure: Recovery Self-efficacy
timeFrame: Change from baseline to 12 weeks
Locations:
city: Holbæk
country: Denmark
facility: Holbæk Hospital
city: Korsør
country: Denmark
facility: City of Slagelse (municipality)
city: Slagelse
country: Denmark
facility: Slagelse Hospital
Study officials:
affiliation: Næstved-Slagelse-Ringsted Hospitals; University of Southern Denmark
name: Rune M Andersen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Næstved-Slagelse-Ringsted Hospitals; University of Southern Denmark
name: Lars H Tang, PhD
role: STUDY_CHAIR
affiliation: Næstved-Slagelse-Ringsted Hospitals; University of Southern Denmark
name: Søren T Skou, PhD
role: STUDY_CHAIR
References:
citation: Andersen RM, Skou ST, Clausen MB, Jager M, Zangger G, Grontved A, Brond JC, Soja AMB, Tang LH. Maintenance of physical activity after cardiac rehabilitation (FAIR): study protocol for a feasibility trial. BMJ Open. 2022 Apr 5;12(4):e060157. doi: 10.1136/bmjopen-2021-060157.