Feasibility, Safety and Performance Evaluation of an Application Based Training Programme for Patients After a Stroke

Stroke Clinical Trial

— TeleRehaStroke  

Official title:

Telerehabilitation After a Stroke: Feasibility, Safety and Performance Evaluation of an Application Based Training Programme for Patients After a Stroke in the Subacute Phase

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06449612
• Other study ID #: TeleRehaStroke
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: June 2024
• Source: Reha Rheinfelden
• Contact: Corina Schuster-Amft, PD Dr. phil. habil
• Phone: +41 61 836 5381
• Email: c.schuster[@]reha-rhf.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• TeleRehaStroke: Training programme using the 'Blended Clinic' mobile application
Primary end users (patients after stroke) will be familiarised with the application and the 'TeleRehaStroke' programme in two to three sessions during their last two to three weeks prior to discharge from the inpatient rehabilitation centre. This includes performing daily exercises, wearing an activity tracker and measuring blood pressure daily. Following discharge from rehabilitation, they will continue to use the application for 12 weeks.

Locations

Country	Name	City	State
Switzerland	Reha Rheinfelden	Rheinfelden	AG

Sponsors (1)

Lead Sponsor	Collaborator
Corina Schuster-Amft

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility process-related parameters: Recruitment rate	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.	through total study completion (up to 12 months)
Primary	Feasibility process-related parameters: Process evaluation	The absolute duration of study-related duties of study personnel/coach in minutes during the inpatient and the outpatient period will be determined.	through total study completion (up to 12 months)
Primary	Feasibility of training-related parameters: (Serious) adverse events and device deficiencies	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.	through study completion, up to 4 months
Primary	Feasibility of training-related parameters: Acceptance	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%.	end of intervention, approx. after 4 months
Primary	Feasibility of training-related parameters: Adherence to exercise and monitoring	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.	through study completion, up to 4 months
Primary	Feasibility of training-related parameters: Drop-out Rate	It will be defined as successful if =80% of enrolled participants will complete the study.	through total study completion (up to 12 months)
Primary	Feasibility of mHealth-related parameters: Stability and maintenance	The number and description of system errors will be determined and defined as acceptable if =3 system failures occur per week.	through total study completion (up to 12 months)
Primary	Feasibility of mHealth-related parameters: Usability measured with the System Usability Scale (SUS)	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.	end of intervention, approx. after 4 months
Primary	Feasibility of mHealth-related parameters: Usability measured with the German version of mHealth App Usability Questionnaire (G-MAUQ)	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.	end of intervention, approx. after 4 months
Primary	Feasibility of mHealth-related parameters: Quality	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.	end of intervention, approx. after 4 months
Primary	Feasibility of mHealth-related parameters: Satisfaction	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.	end of intervention, approx. after 4 months
Primary	Feasibility of mHealth-related parameters: User- and training experience:	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.	end of intervention, approx. after 4 months
Primary	Feasibility of mHealth-related parameters: Perceived change	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.	end of intervention, approx. after 4 months
Secondary	Change in functional status as assessed by the Functional Independence Measure (FIM)	The FIM aims to evaluate the functional status of patients after a stroke throughout the rehabilitation process. It consists of 18 categories focusing on motor and cognitive function. Each category is rated on a 7-point rating scale (from 1: <25% independence to 7: 100% independence).	baseline, discharge (approx. 3 weeks), end of intervention (approx. 4 months)
Secondary	Change in ambulation as assessed by the Functional Ambulation Categories (FAC)	The FAC rates ambulation ability on a six-point rating scale from zero: unable to walk or assistance by walking through two or more assistants to 5: able to walk independently everywhere.	baseline, discharge (approx. 3 weeks), end of intervention (approx. 4 months)
Secondary	Cognition assessed by the Montreal Cognitive Assessment (MoCA) at baseline	The MoCa consists of 30 items. The lowest possible score is zero, the highest is 30.	baseline
Secondary	Level of impairment assessed by the National Institute of Health Stroke Scale (NIHSS) at baseline	The NIHSS consists of 11 items, each item scored between zero and four, where zero indicates normal function of a specific ability, while a higher score indicates some level of impairment. The higher the total score, the severe the impairment caused by a stroke.	baseline
Secondary	Change in disability level on the Modified Rankin Scale (mRS)	The mRS measures the degree of disability or dependence in daily activities in patients after a stroke using a rating scale from zero (no symptoms at all) to six (dead). The mRS score will be evaluated by the study personnel or/and by the patients via the application.	baseline, week 1, discharge (approx. week 3), week 10, end of intervention (approx. 4 months)
Secondary	Change in self-reported disability on the Stroke Impact Scale (SIS)	The SIS is a self-report questionnaire that evaluates disability and health-related quality of life after stroke. The SIS consists of eight subscales (strength, hand function, mobility, activity of daily living, emotion, memory, communication and participation) comprising a total of 59 questions. Patients can rate each item in terms of difficulty on five-point rating scale (from 1: could not do at all to 5: not difficult at all). Final scores range from 0 to 100. The SIS includes an extra question on how much the patient feels that he/she has recovered from stroke that is rated on a scale from 0 to 100.	week 1, discharge (approx. week 3), week 10, end of intervention (approx. 4 months)
Secondary	Change in health-related quality of life assessed by the 36-Item Short Form Healthy Survey (SF-36)	The SF-36 consists of eight sections (physical functioning, role limitations due to physical problems, general health perceptions, vitality, social functioning, role limitation due to emotional problems, general mental health, and health transition) with eight scales scores, which are the weighted sums of the questions in their subscale (0 to 100). The lower the score the higher the impairment. Patients will fill out the questions via application.	week 1, discharge (approx. week 3), week 10, end of intervention (approx. 4 months)
Secondary	Change in quality of life as assessed by the EuroQoL EQ-5D-5L	The EuroQoL consists of six questions about an individuals' quality of life in general, a visual analogue scale with a score from 0 to 100 and descriptive questions about five dimensions. Each dimension can be evaluated using a five-point rating scale (from 1: no problems/pain/fear at all to 5: extreme problems/pain/fear). The descriptive system of the EQ-5D-5L produces a 5-digit health state profile, whereas the value sets are anchored on 11111 representing complete health.	baseline, end of intervention (approx. 4 months)
Secondary	Life-space mobility as assessed by the German Life-Space Assessment (LSA-G)	The LSA-G consists of a questionnaire on five different life spaces: rooms besides the bedroom, area outside the house, neighbourhood, town or city lived in, outside of the town or city lived in. For each life space individuals are asked whether they visited these spaces and how often, whether they needed assistive devices or personal assistance. A life-space level can be determined as well as a composite score which ranges from 0 to 120 points (higher scores indicating better mobility).	discharge (approx. week 3), week 10, end of intervention (approx. 4 months)
Secondary	Change in sitting balance as measured by the Trunk Impairment Scale (TIS)	The TIS assesses static (with three items) and dynamic (with four items, each repeated two or three times) sitting balance and trunk coordination (two items, each repeated twice) in sitting position in patients after a stroke . Score ranges from 0 to 23, where the higher score indicates better balance and coordination.	baseline, end of intervention (approx. 4 months)
Secondary	Change in mobility assessed by the Timed Up and Go (TUG)	The TUG is a clinical tool to assess mobility and the risk of falling. The time patients need to complete the task will be measured in seconds.	baseline, end of intervention (approx. 4 months)
Secondary	Blood pressure and heart rate	Blood pressure and heart rate will be measured with a digital blood pressure measurement device (Medisana BU 510, medisana GmbH, Neuss, Germany).	through study completion, up to 4 months
Secondary	Change in physical performance as assessed by the Short Physical Performance Battery (SPPB)	The SPPB is a group of measures that combines the results of gait speed, chair raise and balance tests. The scores range from 0 to 12 (0: worst performance; 12: best performance).	baseline, end of intervention (approx. 4 months)
Secondary	Physical activity - accelerometry	Activity data will be assessed using the GENEActiv (Activinsights, Kimbolton, UK) activity tracker. Time (in min) spent in different activity levels and steps per day will be determined.	from start of the intervention to discharge (up to 3 weeks), and last 3 weeks before end of intervention (approx. after 3 months)