Maintenance of Physical Activity After Cardiac Rehabilitation: a Feasibility Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- Coordinator time spent, minutes per participant throughout the intervention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Coordinator time spent, minutes per participant throughout the intervention
时间窗: 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
Attrition/retention through follow-up assessment session
时间窗: 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
Accelerometer data completeness
时间窗: 12 weeks
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
Acceptability of text message component, single item
时间窗: 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
Recruitment
时间窗: 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
Response rate on patient reported outcomes
时间窗: 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
Response rate (adherence) to weekly follow-up messages
时间窗: 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
次要结局
- Physical activity, objectively measured(Change from baseline to 12 weeks)
- Physical function, sit-to-stand(Change from baseline to 12 weeks)
- Physical function, walking(Change from baseline to 12 weeks)
- Physical activity, subjectively measured(Change from baseline to 12 weeks)