Arrythmia, Cardiovascular Diseases, Heart Arrest, Heart Diseases, Heart Failure, Myocardial Ischemia
Conditions
Keywords
cardiac rehabilitation, ischemic heart disease
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.
Interventions
BEHAVIORALMaintenance 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
Sponsors
City of Slagelse (municipality)
Holbaek Sygehus
University of Southern Denmark
University College Copenhagen
Slagelse Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment | 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 |
| Acceptability of text message component, single item | 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 |
| Response rate (adherence) to weekly follow-up messages | 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 |
| Coordinator time spent, minutes per participant throughout the intervention | 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 |
| Response rate on patient reported outcomes | 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 |
| Accelerometer data completeness | Baseline | 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 |
| Attrition/retention through follow-up assessment session | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical activity, objectively measured | Change from baseline to 12 weeks | Measured with thigh and wrist accelerometers |
| Physical function, walking | Change from baseline to 12 weeks | 6 minute walking test |
| Physical function, sit-to-stand | Change from baseline to 12 weeks | 30-second sit-to-stand test |
| Physical activity, subjectively measured | 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
| Measure | Time frame | Description |
|---|---|---|
| Anxiety and depression | 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). |
| Health-related quality of life, heart-specific | 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) . |
| Health-related quality of life, VAS subscale | 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. |
| Motivational Self-efficacy | 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). |
| Self-efficacy, managing chronic disease | 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). |
| Comorbidity | 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. |
| Physical function, self-reported | 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). |
| Coping Self-efficacy | 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). |
| Recovery Self-efficacy | 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). |
| Health-related quality of life, general | 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. |
Countries
Denmark
Contacts
Primary ContactRune M Andersen, PhD
Backup ContactLars H Tang, PhD
Outcome results
None listed