Tele-reha Versus Paper-based Aftercare Programme Following Inpatient Rehabilitation

Study Overview
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Brief Summary
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The goal of this three-armed, observer-blinded, randomised controlled trial is to (i) to implement a telerehabilitation intervention in routine care after an inpatient rehabilitation stay for people insured with the Social Insurance Institution for the Self-Employed (SVS), (ii) to evaluate the impact of telerehabilitation on the consolidation of goals achieved during the inpatient stay in everyday life, and (iii) to evaluate whether independence in everyday life can be increased by implementing telerehabilitation at home compared to standard care. Our hypothesis is that the tele-reha intervention, including ongoing therapist support, will improve independence in daily living (defined as the primary outcome of this study), as measured by the Functional Assessment Measure (FAM), compared to a control group receiving a standard paper-based program.

Detailed Description
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All patients admitted to the NRZ receive a Baseline Assessment (T0). Rehabilitation aims are defined based on symptoms, functional limitations and participation restrictions, and routine care is provided accordingly. At discharge, patients undergo another assessment to determine if the rehabilitation aims have been reached (Post-inpatient Evaluation [T1]). Between T0 and T1, patients participating in this study will be randomly assigned to either a tele-reha group (Intervention Group) or a control group (Control Group 1) stratified for the likelihood of a positive rehabilitation outcome (determined by the multidisciplinary team), as well as age, and sex. Participation in the tele-reha group and the control group 1 is restricted to patients with SVS insurance. Additionally, a second control group (Control Group 2) will be recruited from patients without SVS insurance who only receive standard care. Control group 2 will be matched with the tele-reha group in terms of age group, sex and the likelihood of a positive rehabilitation outcome as estimated by the multidisciplinary team. The study concludes with a final assessment (Final Evaluation) after 36 days of therapy. SVS patients from control group 1 will be offered the opportunity to participate in an additional tele-care intervention after the study ends. EvoCare is the platform for implementing the tele-care intervention, with most of the therapeutic content, such as exercise and training videos, produced by the NRZ. In addition, therapeutic content with a focus on cognition is entered into EvoCare and made available. Interventions will be selected based on the patient's primary concern in therapy, with a maximum of two activity goals and a maximum of two treatment foci set. Patients assigned to one of the control groups will continue with the standard care procedure, consisting of a paper-based home-exercise programme provided by the NRZ after discharge from the rehabilitation centre. This intervention is a programme of exercises for the basic motor skills of mobility, sensitivity, strength, endurance, balance and coordination. The supervising therapists select the content during the inpatient treatment and relate it to the patient's structural and activity-related limitations. The patients are given this paper-based programme at the end of their stay and then perform the exercises independently at home without further support.

Official Title
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Implementation and Evaluation of a Tele-reha as Well as a Paper-based Aftercare Programme Following Inpatient Rehabilitation: a Three-armed, Observer-blinded, Randomised Controlled Trial

Conditions
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Neurologic Disorder

Intervention / Treatment
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* Device: Tele-Reha provided with EvoPads
* Other: Paper-based exercises with option to do tele-reha afterwards
* Other: Only paper-based exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 18 years or older, experiencing problems with motor function, sensory function, cognition, swallowing or speech production (regardless of their diagnosis), being insured with SVS, agreeing to telerehabilitation after discharge, having sufficient motor and cognitive abilities to operate a smartphone, tablet or PC, or being sufficiently supported by caregivers, and being able to independently perform the targeted tasks assigned to them. Exclusion Criteria: - pronounced impairments in awareness, memory, attention, spatial performance, executive performance, apraxia, speech, and visual perception that do not allow a safe study participation according to the treating physicians or therapists

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group Tele-reha (1)<br>Tele-reha group | Device: Tele-Reha provided with EvoPads<br>* Exercises and cognitive training provided on an EvoPad<br>|
| Active Comparator: Control Group Paper-based exercises (1)<br>Paper-based exercises with option to do tele-reha afterwards | Other: Paper-based exercises with option to do tele-reha afterwards<br>* Similar exercises and cognitive training as Group 1 provided on paper. Patients receive the Tele-Reha afterwards<br>|
| Active Comparator: Control Group Paper-based exercises (2)<br>Only paper-based exercises | Other: Only paper-based exercises<br>* Same exercises and cognitive training as Group 2 provided on paper only.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of change in the Functional Assessment Measure (Changes from baseline measurement to evaluation at the end of inpatient rehabilitation to evaluation after the tele-rehab intervention) | Score 18-126 (higher score indication better functioning in everyday life) | Baseline evaluation at start of inpatient rehabilitation (in protocol referred to as T0), Evaluation at the end of inpatient rehabilitation up to 12 Weeks after T0 (in protocol referred to as T1), Evaluation after tele-reha up to 10 weeks after T1 (T2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Measure | Numeric Rating Scale (NRS) 0-100 (higher score indicating better quality of life) | Baseline evaluation at start of inpatient rehabilitation (in protocol referred to as T0), Evaluation at the end of inpatient rehabilitation up to 12 Weeks after T0 (in protocol referred to as T1) , Evaluation after tele-reha up to 10 weeks after T1 (T2) | 
| Pain level at the moment | NRS 0-100 (higher score indicating more symptomatology) | Baseline evaluation at start of inpatient rehabilitation (in protocol referred to as T0), Evaluation at the end of inpatient rehabilitation up to 12 Weeks after T0 (in protocol referred to as T1) , Evaluation after tele-reha up to 10 weeks after T1 (T2) | 
| Pain level on average in the last weeks | NRS 0-100 (higher score indicating more symptomatology) | Baseline evaluation at start of inpatient rehabilitation (in protocol referred to as T0), Evaluation at the end of inpatient rehabilitation up to 12 Weeks after T0 (in protocol referred to as T1) , Evaluation after tele-reha up to 10 weeks after T1 (T2) | 
| Health Status | NRS 0-100 (higher score indicating better health status) | Baseline evaluation at start of inpatient rehabilitation (in protocol referred to as T0), Evaluation at the end of inpatient rehabilitation up to 12 Weeks after T0 (in protocol referred to as T1) , Evaluation after tele-reha up to 10 weeks after T1 (T2) | 
| Center for Epidemiologic Studies Depression Scale (CESD) | 0-60 (higher socre indicating more symptomatology) | Baseline evaluation at start of inpatient rehabilitation (in protocol referred to as T0), Evaluation at the end of inpatient rehabilitation up to 12 Weeks after T0 (in protocol referred to as T1) , Evaluation after tele-reha up to 10 weeks after T1 (T2) | 
| ZUF 8 Patient satisfaction | 1-4 (score varies according to questions) | Baseline evaluation at start of inpatient rehabilitation (in protocol referred to as T0), Evaluation at the end of inpatient rehabilitation up to 12 Weeks after T0 (in protocol referred to as T1) , Evaluation after tele-reha up to 10 weeks after T1 (T2) | 
| Goal achievement scale | 1-5 (higher score indicating worse goal achievement) | Evaluation at the end of inpatient rehabilitation up to 12 Weeks after T0 (in protocol referred to as T1), Evaluation after tele-reha up to 10 weeks after T1 (T2) | 
| Experience with tele-care | 1-4 (score varies according to questions) | Evaluation after tele-reha up to 10 weeks after T1 (in protocol referred to asT2) | 
| Experience with standard care | 1-4 (score varies according to questions) | Evaluation after tele-reha up to 10 weeks after T1 (in protocol referred to as T2) |