Maintenance of Physical Activity After Cardiac Rehabilitation
NCT ID: NCT05011994
Last Updated: 2022-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2021-08-30
2022-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Maintenance intervention
Participants will receive a 12-week mobile health (mHealth) intervention that consists of action planning, text messages, and coordinator support.
Maintenance intervention
The intervention consists of action planning, text messages, and coordinator support.
At onset, each participant creates an action plan for physical activity with the help of a health professional:
* What types of physical activities?
* When and how often?
* Where and with who?
2 auto-generated text messages are sent weekly for a duration of 12 weeks. The first prompts physical activity. The second asks if plans were reached. If yes, an automatic reply with positive reinforcement is generated. If no, an automatic reply asks if the participant wants to be contacted.
Participants are contacted by a coordinator either by answering text messages or if not answering the texts for a period of 2 weeks or more. Coordinator functions:
* Call participants replying to texts that they wish to be contacted
* Help participants establish contact to local activities involving physical activity
* Follow-up on and adjustment of action plan
* Offer guidance in physical activity
Interventions
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Maintenance intervention
The intervention consists of action planning, text messages, and coordinator support.
At onset, each participant creates an action plan for physical activity with the help of a health professional:
* What types of physical activities?
* When and how often?
* Where and with who?
2 auto-generated text messages are sent weekly for a duration of 12 weeks. The first prompts physical activity. The second asks if plans were reached. If yes, an automatic reply with positive reinforcement is generated. If no, an automatic reply asks if the participant wants to be contacted.
Participants are contacted by a coordinator either by answering text messages or if not answering the texts for a period of 2 weeks or more. Coordinator functions:
* Call participants replying to texts that they wish to be contacted
* Help participants establish contact to local activities involving physical activity
* Follow-up on and adjustment of action plan
* Offer guidance in physical activity
Eligibility Criteria
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Inclusion Criteria
* 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
* Patients cognitively or mentally unable to participate.
* Terminal patients and patients with a life expectancy of less than 3 months.
18 Years
ALL
No
Sponsors
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City of Slagelse (municipality)
UNKNOWN
Holbaek Sygehus
OTHER
University of Southern Denmark
OTHER
University College Copenhagen
OTHER
Slagelse Hospital
OTHER
Responsible Party
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Principal Investigators
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Rune M Andersen, PhD
Role: PRINCIPAL_INVESTIGATOR
Næstved-Slagelse-Ringsted Hospitals; University of Southern Denmark
Lars H Tang, PhD
Role: STUDY_CHAIR
Næstved-Slagelse-Ringsted Hospitals; University of Southern Denmark
Søren T Skou, PhD
Role: STUDY_CHAIR
Næstved-Slagelse-Ringsted Hospitals; University of Southern Denmark
Locations
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Holbæk Hospital
Holbæk, , Denmark
City of Slagelse (municipality)
Korsør, , Denmark
Slagelse Hospital
Slagelse, , Denmark
Countries
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Central Contacts
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References
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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.
Related Links
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Link to published study protocol
Other Identifiers
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EMN-2021-00020
Identifier Type: OTHER
Identifier Source: secondary_id
REG-162-2020
Identifier Type: OTHER
Identifier Source: secondary_id
EMN-2021-00020
Identifier Type: -
Identifier Source: org_study_id
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