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| ID | Type | Description | Link |
|---|---|---|---|
| EMN-2021-00020 | Other Identifier | Research Ethics Committee of Region Zealand, Denmark | |
| REG-162-2020 | Other Identifier | Danish Data Protection Agency through Region Zealand |
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| Name | Class |
|---|---|
| City of Slagelse (municipality) | UNKNOWN |
| Holbaek Sygehus | OTHER |
| University of Southern Denmark | OTHER |
| University College Copenhagen |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maintenance intervention | Experimental | Participants will receive a 12-week mobile health (mHealth) intervention that consists of action planning, text messages, and coordinator support. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maintenance intervention | Behavioral | 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:
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:
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| Measure | Description | Time Frame |
|---|---|---|
| Recruitment | 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 | Baseline |
| Attrition/retention through follow-up assessment session | 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 | Up to 12 weeks |
| Accelerometer data completeness | Green: Accelerometer data from both baseline and follow-up available on ≥80% of completing participants Amber: Data available on 50-79% of completing participants Red: Data available on <50% of completing participants | Baseline |
| Accelerometer data completeness | Green: Accelerometer data from both baseline and follow-up available on ≥80% of completing participants Amber: Data available on 50-79% of completing participants Red: Data available on <50% of completing participants | 12 weeks |
| Response rate on patient reported outcomes | 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 | Baseline |
| Response rate on patient reported outcomes | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Physical activity, objectively measured | Measured with thigh and wrist accelerometers | Change from baseline to 12 weeks |
| Physical function, walking | 6 minute walking test |
| Measure | Description | Time Frame |
|---|---|---|
| Health-related quality of life, general | 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. | Change from baseline to 12 weeks |
| Health-related quality of life, VAS subscale |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rune M Andersen, PhD | Contact | +4529623522 | +4558559790 | ruma@regionsjaelland.dk |
| Lars H Tang, PhD | Contact | +4558559790 | larta@regionsjaelland.dk |
| Name | Affiliation | Role |
|---|---|---|
| Rune M Andersen, PhD | Næstved-Slagelse-Ringsted Hospitals; University of Southern Denmark | Principal Investigator |
| Lars H Tang, PhD | Næstved-Slagelse-Ringsted Hospitals; University of Southern Denmark | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holbæk Hospital | Recruiting | Holbæk | 4300 | Denmark | ||
| City of Slagelse (municipality) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35383088 | Derived | 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. |
| Label | URL |
|---|---|
| Link to published study protocol | View source |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D017202 | Myocardial Ischemia |
| D006333 | Heart Failure |
| D001145 | Arrhythmias, Cardiac |
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| OTHER |
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| 12 weeks |
| Coordinator time spent, minutes per participant throughout the intervention | 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 | 12 weeks |
| Response rate (adherence) to weekly follow-up messages | 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 | 12 weeks |
| Acceptability of text message component, single item | 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 | 12 weeks |
| Change from baseline to 12 weeks |
| Physical function, sit-to-stand | 30-second sit-to-stand test | Change from baseline to 12 weeks |
| Physical activity, subjectively measured | The International Physical Activity Questionnaire (IPAQ) is used to measure physical activity in the past 7 days. 0 is minimum (completely inactivty). | 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. |
| Change from baseline to 12 weeks |
| Health-related quality of life, heart-specific | HeartQoL is used to measure heart-specific quality of life in the past 4 weeks. Range from 0 (worst) to 42 (best) . | Change from baseline to 12 weeks |
| Anxiety and depression | Hospital Anxiety and Depression Scale (HADS). HADS gives a score for each of anxiety and depression, each ranging from 0 (best) to 21 (worst). | Change from baseline to 12 weeks |
| Physical function, self-reported | 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). | Change from baseline to 12 weeks |
| Comorbidity | 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. | Change from baseline to 12 weeks |
| Self-efficacy, managing chronic disease | 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). | Change from baseline to 12 weeks |
| Motivational Self-efficacy | 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). | Change from baseline to 12 weeks |
| Coping Self-efficacy | 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). | Change from baseline to 12 weeks |
| Recovery Self-efficacy | 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). | Change from baseline to 12 weeks |
| Søren T Skou, PhD | Næstved-Slagelse-Ringsted Hospitals; University of Southern Denmark | Study Chair |
| Recruiting |
| Korsør |
| 4220 |
| Denmark |
| Slagelse Hospital | Recruiting | Slagelse | 4200 | Denmark |