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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
40
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
Holbæk Hospital
Holbæk, Denmark
RECRUITINGCity of Slagelse (municipality)
Korsør, Denmark
RECRUITINGSlagelse Hospital
Slagelse, Denmark
RECRUITINGRecruitment
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 weeks
Physical activity, objectively measured
Measured with thigh and wrist accelerometers
Time frame: Change from baseline to 12 weeks
Physical function, walking
6 minute walking test
Time frame: Change from baseline to 12 weeks
Physical function, sit-to-stand
30-second sit-to-stand test
Time frame: 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).
Time frame: Change from baseline to 12 weeks
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