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Maintenance of Physical Activity After Cardiac Rehabilitation (FAIR)

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ClinicalTrials.gov Identifier: NCT05011994
Recruitment Status : Recruiting
First Posted : August 19, 2021
Last Update Posted : September 20, 2021
Sponsor:
Collaborators:
City of Slagelse (municipality)
Holbaek Sygehus
University of Southern Denmark
University College Copenhagen
Information provided by (Responsible Party):
Slagelse Hospital

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Heart Diseases Myocardial Ischemia Heart Failure Arrythmia Heart Arrest Behavioral: Maintenance intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Maintenance of Physical Activity After Cardiac Rehabilitation: a Feasibility Trial
Actual Study Start Date : August 30, 2021
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Maintenance intervention
Participants will receive a 12-week mobile health (mHealth) intervention that consists of action planning, text messages, and coordinator support.
Behavioral: 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




Primary Outcome Measures :
  1. Recruitment [ Time Frame: Baseline ]

    Green: Mean of ≥0.75 recruited participants per week per site

    Amber: Mean of 0.5-0.74 recruited participants per week per site

    Red: Mean of <0.5 recruited participants per week per site


  2. Attrition/retention through follow-up assessment session [ Time Frame: Up to 12 weeks ]

    Green: ≥80% retention of participants through follow up

    Amber: 50-79% retention of participants through follow up

    Red: <50% retention of participants through follow up


  3. Accelerometer data completeness [ Time Frame: Baseline ]

    Green: Accelerometer data from both baseline and follow-up available on ≥75% of completing participants

    Amber: Data available on 50-74% of completing participants

    Red: Data available on <50% of completing participants


  4. Accelerometer data completeness [ Time Frame: 12 weeks ]

    Green: Accelerometer data from both baseline and follow-up available on ≥75% of completing participants

    Amber: Data available on 50-74% of completing participants

    Red: Data available on <50% of completing participants


  5. Response rate on patient reported outcomes [ Time Frame: Baseline ]

    Green: ≥90% of participants attending baseline and follow-up assessment return patient reported outcomes

    Amber: 75-89% of patients attending baseline and follow-up assessment return patient reported outcomes

    Red: <75% of participants attending baseline and follow-up assessment return patient reported outcomes


  6. Response rate on patient reported outcomes [ Time Frame: 12 weeks ]

    Green: ≥90% of participants attending baseline and follow-up assessment return patient reported outcomes

    Amber: 75-89% of patients attending baseline and follow-up assessment return patient reported outcomes

    Red: <75% of participants attending baseline and follow-up assessment return patient reported outcomes


  7. Coordinator time spent, minutes per participant throughout the intervention [ Time Frame: 12 weeks ]

    Green: Mean coordinator time spent of ≤30 minutes per participant

    Amber: Mean coordinator time spent of 31-60 minutes per participant

    Red: Mean coordinator time spent of >60 minutes per participant


  8. Response rate (adherence) to weekly follow-up messages [ Time Frame: 12 weeks ]

    Green: ≥75% of patients respond to at least 75% of messages

    Amber: 50-74% of patients respond to at least 75% of messages

    Red: <50% of patients respond to at least 75% of messages


  9. Acceptability of text message component, single item [ Time Frame: 12 weeks ]

    Green: ≥75% of participants find text messages acceptable

    Amber: 50-74% of participants find text messages acceptable

    Red: <50% of participants find text messages acceptable



Secondary Outcome Measures :
  1. Physical activity, objectively measured [ Time Frame: Change from baseline to 12 weeks ]
    Measured with thigh and wrist accelerometers

  2. Physical function, walking [ Time Frame: Change from baseline to 12 weeks ]
    6 minute walking test

  3. Physical function, sit-to-stand [ Time Frame: Change from baseline to 12 weeks ]
    30-second sit-to-stand test

  4. Physical activity, subjectively measured [ Time Frame: Change from baseline to 12 weeks ]
    The International Physical Activity Questionnaire (IPAQ) is used to measure physical activity in the past 7 days. 0 is minimum (completely inactivty).


Other Outcome Measures:
  1. Health-related quality of life, general [ Time Frame: Change from baseline to 12 weeks ]
    EQ-5D-5L evaluates health status in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated from 1 (best) to 5 (worst) and overall health is rated on a 0 to 100 VAS scale.

  2. Health-related quality of life, VAS subscale [ Time Frame: Change from baseline to 12 weeks ]
    EQ-5D-5L evaluates health status in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated from 1 (best) to 5 (worst) and overall health is rated on a 0 to 100 VAS scale.

  3. Health-related quality of life, heart-specific [ Time Frame: Change from baseline to 12 weeks ]
    HeartQoL is used to measure heart-specific quality of life in the past 4 weeks. Range from 0 (worst) to 42 (best) .

  4. Anxiety and depression [ Time Frame: Change from baseline to 12 weeks ]
    Hospital Anxiety and Depression Scale (HADS). HADS gives a score for each of anxiety and depression, each ranging from 0 (best) to 21 (worst).

  5. Physical function, self-reported [ Time Frame: Change from baseline to 12 weeks ]
    WHO Disability Assessment Schedule 2.0 (WHODAS 2.0),12-item version. WHODAS is a generic assessment instrument for health and disability. Range from 12 (no disability) to 60 (highest disability or loss of function).

  6. Comorbidity [ Time Frame: Change from baseline to 12 weeks ]
    Disease Burden: Morbidity Assessment by Self-Report used to evaluated a list of common chronic conditions affect the participants' daily activities. Each condition (that the participant has) is rated from 1 (not at all) to 5 (a lot) in regard to how much it limits daily activities.

  7. Self-efficacy, managing chronic disease [ Time Frame: Change from baseline to 12 weeks ]
    Self-efficacy of managing chronic disease 6 items scale. Score is calculated as the mean of 6 items, each scored from 1 (low self-efficacy) to 10 (high self-efficacy).

  8. Motivational Self-efficacy [ Time Frame: Change from baseline to 12 weeks ]
    Motivational self-efficacy, HAPA items by Schwartzer R., 2 items each rated on a scale from 1 (low self-efficacy) to 4 (high self-efficacy).

  9. Coping Self-efficacy [ Time Frame: Change from baseline to 12 weeks ]
    Coping self-efficacy, HAPA items by Schwartzer R., 2 items each rated on a scale from 1 (low self-efficacy) to 4 (high self-efficacy).

  10. Recovery Self-efficacy [ Time Frame: Change from baseline to 12 weeks ]
    Recovery self-efficacy, HAPA items by Schwartzer R., 2 items each rated on a scale from 1 (low self-efficacy) to 4 (high self-efficacy).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05011994


Contacts
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Contact: Rune M Andersen, PhD +4529623522 ext +4558559790 ruma@regionsjaelland.dk
Contact: Lars H Tang, PhD +4558559790 larta@regionsjaelland.dk

Locations
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Denmark
Holbæk Hospital Not yet recruiting
Holbæk, Denmark, 4300
City of Slagelse (municipality) Recruiting
Korsør, Denmark, 4220
Slagelse Hospital Not yet recruiting
Slagelse, Denmark, 4200
Sponsors and Collaborators
Slagelse Hospital
City of Slagelse (municipality)
Holbaek Sygehus
University of Southern Denmark
University College Copenhagen
Investigators
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Principal Investigator: Rune M Andersen, PhD Næstved-Slagelse-Ringsted Hospitals; University of Southern Denmark
Study Chair: Lars H Tang, PhD Næstved-Slagelse-Ringsted Hospitals; University of Southern Denmark
Study Chair: Søren T Skou, PhD Næstved-Slagelse-Ringsted Hospitals; University of Southern Denmark
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Responsible Party: Slagelse Hospital
ClinicalTrials.gov Identifier: NCT05011994    
Other Study ID Numbers: EMN-2021-00020
EMN-2021-00020 ( Other Identifier: Research Ethics Committee of Region Zealand, Denmark )
REG-162-2020 ( Other Identifier: Danish Data Protection Agency through Region Zealand )
First Posted: August 19, 2021    Key Record Dates
Last Update Posted: September 20, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Slagelse Hospital:
cardiac rehabilitation
ischemic heart disease
Additional relevant MeSH terms:
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Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Heart Arrest
Ischemia
Pathologic Processes
Vascular Diseases