ENAbLE-Sweden. Secondary Prevention of Stroke: Mobile Health to Promote Physical Activity in People Post Stroke or Transient Ischemic Attack
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Compliance to treatment protocols
研究概览
简要总结
Support for physical activity is necessary to sustain health and reduce the risk of stroke recurrence after stroke or transient ischemic attack (TIA). Still, rehabilitation services are not available to many of those who potentially would benefit from such services largely due to barriers related to accessibility. While mobile health is a promising strategy to support physical activity, there is a gap in knowledge regarding the implementation of technology that meet the needs of people post stroke or TIA in order to foster adherence and engagement in physical activity. This project therefore seeks to improve health and reduce the risk of recurrent stroke among people post stroke or TIA by increasing the access to physical activity through telehealth.
The present project builds on experiences of telehealth-delivered physical activity in Australia where restricted access to health-care services is a longstanding problem. Collaborating researchers in Australia have developed a telehealth program (i-REBOUND- Let's get moving) which has been designed and tested in collaboration with end users, through a series of feasibility and pilot studies. The i-REBOUND program provides support for physical activity through physical exercises supervised by a physiotherapist and behavior change techniques for physical activity (i.e. individual counseling, information, recommendations, goal-setting, self-monitoring and structured follow-ups) across 6 months. The intervention is delivered to people post stroke or TIA in their own homes via video-meeting.
This study, which is conducted in Sweden, aims to evaluate if the i-REBOUND program supported by a new mobile application could be delivered as intended through a pilot randomized controlled trial in order to determine the feasibility and preliminary effects in people post stroke or TIA living in urban and rural regions of Sweden.
详细描述
In order to make the i-REBOUND program accessible to people post stroke or TIA across Sweden, a mobile application was developed in a co-design process with people post stroke or TIA, physiotherapists and stakeholders. The application enables monitoring and management of exercise (supervised online and prescribed exercise), communication through video calls and chat, self-monitoring of exercise compliance and physical activity, and scheduled digital surveys on function and health. The application will be used in this study to deliver the experimental and control intervention, but also for remote assessments of function and health (e.g. digital questionnaires).
Study participants will be randomized to 1) an experimental group (n=60) receiving the mobile health version of the i-REBOUND program or 2) a control group (n=60) receiving behavioural change techniques for physical activity. The randomization schedule; 1:1, will be blocked and stratified by mobility status (independent/mobility device users) and geographical region (urban/rural areas).
Recruitment: Participants will be recruited through a national network of clinical sites across Sweden, social media and patient organizations.
Screening: Potential participants will be contacted via phone and verbal consent will be sought to provide further information. During this phone conversation, trial eligibility will be assessed according to the inclusion/exclusion criteria using a standardized checklist, including questions regarding cognitive functioning and the individual's usage of mobile applications.
Sample size: The anticipated sample size of 60 participants per group (total 120) builds on the ambition to test the feasibility of the i-REBOUND program among people post stroke/TIA with variation in disability, age and sex, and geographical location within Sweden (i.e. cities and rural areas).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
The researcher responsible for data management and analysis of the secondary outcomes will be blinded to group allocation.
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
- •Aged over 18 years
- •Diagnosed with stroke/TIA between 3 months to 10 years prior to study enrollment
- •Living at home
- •Have sufficient cognitive ability and/or support from family member in order to engage in the interventions
- •Being able to walk short distances indoors
- •Ability to use a smartphone/tablet including access to stable internet connection.
排除标准
- •Medical conditions limiting the ability to exercise (e.g. unstable cardiac conditions or severe arthritis)
- •Severe neglect and aphasia compromising the ability to follow instructions
- •Meeting the recommended physical activity levels of at least 150 min per week of moderate physical activity or at least 75 min per week of vigorous intensity physical activity
- •Enrolled in another physical activity trial.
结局指标
主要结局
Compliance to treatment protocols
时间窗: Throughout the intervention period (0-6 months)
Adherence to treatment schedules.
Fidelity - exercise dose
时间窗: Throughout the intervention period (0-6 months)
Performed exercise dose (i.e. number of sessions).
Recruitment rate
时间窗: Throughout the intervention period (0-6 months)
The proportion of participants screened who will be deemed eligible for the trial and the proportion of those consented who will be randomized to the trial.
Compliance to the intervention protocol
时间窗: Throughout the intervention period (0-6 months)
Number of intervention sessions not completed and the reason for uncompleted sessions.
Adverse events
时间窗: Throughout the study period (0-12 months)
Adverse events may include falls, injuries, gastrointestinal issues requiring medical review or cardiac events. Trial therapists will record any adverse events that occur during telehealth sessions, and participants will answer a study specific questionnaire at the commencement of each exercise session, and at each assessment to self-report any adverse events that occur at other times during the study.
Compliance to the clinical trial
时间窗: Throughout the intervention period (0-6 months)
Number of participants who will not complete the trial.
Fidelity - individual physical activity counseling
时间窗: Throughout the intervention period (0-6 months)
Performance of individual physical activity counseling.
Sample representativeness
时间窗: Throughout the intervention period (0-6 months)
Contrasting the demographic details of study sample with national data.
Fidelity - physical intensity
时间窗: Throughout the intervention period (0-6 months)
Performed exercise intensity assessed using the Borg Rating of Perceived Exertion Scale. The Borg Rating of Perceived Exertion Scale assess perceived exertion based on a 6 to 20 rating scale (higher score = higher perceived exertion).
Fidelity - information on physical activity and health
时间窗: Throughout the intervention period (0-6 months)
Provision of information on physical activity and health.
Compliance to the assessment protocols
时间窗: Throughout the intervention period (0-6 months)
Adherence to assessment schedules.
Fidelity - individual physical activity goals
时间窗: Throughout the intervention period (0-6 months)
Establishment of individual physical activity goals.
Fidelity - structured follow-ups of goal fulfillment
时间窗: Throughout the intervention period (0-6 months)
Performance of structured follow-ups of goal fulfillment.
次要结局
- Self-efficacy for exercise(3 months, 6 months, and 12 months after baseline assessment)
- Sedentary - sitting time(3 months, 6 months, and 12 months after baseline assessment)
- Walking abilities(3 months, 6 months, and 12 months after baseline assessment)
- Fatigue(3 months, 6 months, and 12 months after baseline assessment)
- Depression, anxiety and stress(3 months, 6 months, and 12 months after baseline assessment)
- Systolic blood pressure(3 months, 6 months, and 12 months after baseline assessment)
- Physical activity - standing time(3 months, 6 months, and 12 months after baseline assessment)
- Physical activity - walking time(3 months, 6 months, and 12 months after baseline assessment)
- Physical activity - number of daily steps(3 months, 6 months, and 12 months after baseline assessment)
- Confidence performing daily activities(3 months, 6 months, and 12 months after baseline assessment)
- Health-related Quality of life(6 months, and 12 months after baseline assessment)
研究者
David Moulaee Conradsson
Associate professor
Karolinska Institutet