Telerehabilitation After a Stroke: Feasibility, Safety and Performance Evaluation of an Application Based Training Programme for Patients After a Stroke in the Subacute Phase
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Feasibility process-related parameters: Process evaluation
研究概览
简要总结
The goal of this investigation is to evaluate the feasibility, safety and performance of an application-based training programme in patients after a stroke in the subacute phase.
- Is the training programme 'TeleRehaStroke' using the mobile application 'Blended Clinic' for patients after a stroke feasible and usable?
- How is the user experience of the mobile application-based training programme?
Participants will:
- Get to know the programme and use the application 'Blended Clinic' during their last weeks before discharge from the inpatient rehabilitation.
- Be guided through inpatient setting, transition and outpatient setting and be accompanied by a coaching therapist via the application.
- Continue to use the application for 12 weeks after discharge from rehabilitation.
详细描述
It is challenging for patients after stroke to maintain motivation to continue and sustain training at home with the same intensity after an inpatient rehabilitation. An emerging approach is represented by digital applications that are easily and flexibly accessible from home. An existing virtual blended care environment 'Blended Clinic' (Blended Clinic AI GmbH) involves a mobile application that provides a training platform for patients after a stroke. The successor version 'TeleRehaStroke' builds on the previous version 'Strokecoach' that comprises three main modules: (1) training, (2) coaching, and (3) monitoring.
The aim of this evaluation is to assess feasibility, safety and performance of the 'TeleRehaStroke' programme for stroke patients in the transition phase from inpatient to outpatient rehabilitation.
Patients after a stroke will be recruited in the subacute phase. They will use the 'TeleRehaStroke' programme during their last weeks of their inpatient rehabilitation and for a further 12 weeks following their discharge to an outpatient setting. This includes daily exercises and blood pressure measurements. In addition, patients will receive coaching messages, educational content and questionnaires via the application. They will be accompanied by a coach via the app.
Feasibility outcomes, patient's descriptive, clinical- and performance-based parameters will be evaluated. Outcomes will be assessed at different time points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Clinically confirmed stroke
- •Modified Rankin Scale score 1-5
- •Able, to read and understand German language
- •Owns a smartphone or a tablet with stable internet connection and the operating system Android version 11 or iOS version 14 or higher
排除标准
- •Severe Aphasia
- •Clinically significant concomitant disease states: visual, neurological, cardiorespiratory, psychiatric, or orthopaedic limitations that prevent a participant from following the investigator's instructions or limit performance in an exercise programme
- •Recent events such as surgery or other surgical procedures, fractures, which limit the performance in an exercise programme
- •Known or suspected non-compliance, drug or alcohol abuse
- •Participation in another investigation (with interventional therapy, investigational drug or another medical device) within the 30 days preceding and during the present investigation.
结局指标
主要结局
Feasibility process-related parameters: Process evaluation
时间窗: through total study completion (up to 12 months)
The absolute duration of study-related duties of study personnel/coach in minutes during the inpatient and the outpatient period will be determined.
Feasibility of mHealth-related parameters: Usability measured with the System Usability Scale (SUS)
时间窗: end of intervention, approx. after 4 months
The SUS consists of 10 statements considering the system evaluated on a five-point rating scale from strongly agree to strongly disagree. Scores above 70 represent an acceptable usability, with scores smaller than 50 being judged as unacceptable.
Feasibility of mHealth-related parameters: Quality
时间窗: end of intervention, approx. after 4 months
The user version of the Quality Assessment of Health related Apps (AQUA) consists of 31 items and assesses seven basic dimension of app-quality. All items use a five-point rating scale from 5 (strongly agree) to 1 (strongly disagree). By calculating the mean score for each dimension, the quality of an app with regard to each of the dimensions can be determined and compared. By calculating the overall mean a total score can be determined. Success is defined if the average scoring in each dimension is ≥3.
Feasibility of training-related parameters: (Serious) adverse events and device deficiencies
时间窗: through study completion, up to 4 months
Number of adverse events (i.e., deaths, serious and non-serious adverse events as well as device deficiencies) will be reported for each patient. The criterion for success is the incidence of an adverse event in \<10% of participants.
Feasibility of training-related parameters: Acceptance
时间窗: end of intervention, approx. after 4 months
Patient satisfaction will be measured with the Net Promoter Score (NPS). It involves a single question ('How likely is it that you would recommend TeleRehaStroke to a friend or colleague?' with an 11-point rating scale. It will be considered as successful if the average satisfaction is ≥50%.
Feasibility process-related parameters: Recruitment rate
时间窗: through total study completion (up to 12 months)
The number of screened patients versus included patients. It will be considered feasible if ≥40% of informed patients will be enrolled and ≥75% of targeted sample size will be reached.
Feasibility of training-related parameters: Drop-out Rate
时间窗: through total study completion (up to 12 months)
It will be defined as successful if ≥80% of enrolled participants will complete the study.
Feasibility of mHealth-related parameters: Stability and maintenance
时间窗: through total study completion (up to 12 months)
The number and description of system errors will be determined and defined as acceptable if ≤3 system failures occur per week.
Feasibility of mHealth-related parameters: Satisfaction
时间窗: end of intervention, approx. after 4 months
Patient's subjective satisfaction will be assessed using a visual analogue scale from not satisfied at all to extremely satisfied. ('How satisfied are you with the application?'). An average satisfaction of ≥50% is considered a success.
Feasibility of mHealth-related parameters: User- and training experience:
时间窗: end of intervention, approx. after 4 months
A self-designed feedback questionnaire with a five-point rating scale (1: extremely negative to 5: extremely positive) including specific questions related to user experience, interaction with the devices, and coaching experience will be used.
Feasibility of training-related parameters: Adherence to exercise and monitoring
时间窗: through study completion, up to 4 months
Exercise adherence will be measured as the ratio of completed versus planned trainings. Monitoring adherence will be measured as the ratio of completed versus planned blood pressure measurements and activity tracker wearing time. Adherence ≥70% will be considered as successful.
Feasibility of mHealth-related parameters: Usability measured with the German version of mHealth App Usability Questionnaire (G-MAUQ)
时间窗: end of intervention, approx. after 4 months
The G-MAUQ consists of 18 items distributed across three dimensions: ease of use, interface and satisfaction and usefulness. Using a 7-point rating scale, from 1 (strongly agree) to 7 (strongly disagree), patients rate each item. An average scoring of ≥4 will count as successful.
Feasibility of mHealth-related parameters: Perceived change
时间窗: end of intervention, approx. after 4 months
Patients' subjective global perceived change will be assessed using a visual analogue scale (VAS) from very much worse to very much improved ('How would you characterise the change?'). It will be considered as acceptable if the health status at least remains the same.
次要结局
- Change in functional status as assessed by the Functional Independence Measure (FIM)(baseline, discharge (approx. 3 weeks), end of intervention (approx. 4 months))
- Change in ambulation as assessed by the Functional Ambulation Categories (FAC)(baseline, discharge (approx. 3 weeks), end of intervention (approx. 4 months))
- Cognition assessed by the Montreal Cognitive Assessment (MoCA) at baseline(baseline)
- Level of impairment assessed by the National Institute of Health Stroke Scale (NIHSS) at baseline(baseline)
- Change in disability level on the Modified Rankin Scale (mRS)(baseline, week 1, discharge (approx. week 3), week 10, end of intervention (approx. 4 months))
- Change in self-reported disability on the Stroke Impact Scale (SIS)(week 1, discharge (approx. week 3), week 10, end of intervention (approx. 4 months))
- Change in health-related quality of life assessed by the 36-Item Short Form Healthy Survey (SF-36)(week 1, discharge (approx. week 3), week 10, end of intervention (approx. 4 months))
- Change in quality of life as assessed by the EuroQoL EQ-5D-3L(baseline, end of intervention (approx. 4 months))
- Change in mobility assessed by the Timed Up and Go (TUG)(baseline, end of intervention (approx. 4 months))
- Life-space mobility as assessed by the German Life-Space Assessment (LSA-G)(discharge (approx. week 3), week 10, end of intervention (approx. 4 months))
- Change in sitting balance as measured by the Trunk Impairment Scale (TIS)(baseline, end of intervention (approx. 4 months))
- Blood pressure and heart rate(through study completion, up to 4 months)
- Change in physical performance as assessed by the Short Physical Performance Battery (SPPB)(baseline, end of intervention (approx. 4 months))
- Physical activity - accelerometry(from start of the intervention to discharge (up to 3 weeks), and last 3 weeks before end of intervention (approx. after 3 months))
研究者
Corina Schuster-Amft
Head of Research Department
Reha Rheinfelden