Post Stroke Spasticity
Conditions
Interventions
Group 1: Intervention
Participants in the intervention group will receive access to a new model of care in the form of a digitally supported care management program. This program comprises interdiscip
Sponsors
Mobil Krankenkasse
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1- Relevant spasticity (G81.1, G82.1, G82.4, G81.9) following stroke (I60*, I61*, I63*, I64*, I69*); assessed by treating practitioner 2- The stroke must not have occurred more than six months prior to inclusion 3- Patients treated by participating healthcare providers 4- Availability of an email address and an internet-enabled smartphone. If technically feasible, support by relatives is permitted 5- Statutory health insurance coverage 6- Signed declaration of participation/informed consent form provided by the patient
Exclusion criteria
Exclusion criteria: 1- Language or neurocognitive barriers that preclude study participation 2- Insufficient proficiency in the German language if valid participation in study-related questionnaires and informed consent discussions is not possible 3- Concurrent participation in another interventional study 4- Residence outside the study region 5- Private health insurance coverage (implementation of the new model of care is provided by statutory health insurance funds within the framework of a selective contract pursuant to Section 140a of the SGB V or a treatment contract pursuant to Sections 630a–c of the BGB) 6- Other medical or ethical reasons that, in the justified assessment of the treating physician, preclude participation; the decision must be documented
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Health status of the patient, measured using the WHODAS 2.0 (World Health Organization Disability Assessment Schedule 2.0), at 8 months after study enrollment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1- Subjective quality of life of the patient, measured using the EQ-5D-5L (EuroQol 5-Dimension 5-Level Questionnaire), at 8 months after study enrollment 2- Spasticity, measured using the MAS (Modified Ashworth Scale) and the Zorowitz questionnaire, at 8 months after study enrollment 3- Caregiver burden, measured using the Caregiver Strain Index, at 8 months after study enrollment 4- Anxiety and depressive symptoms of the patient, measured using the HADS-D (Hospital Anxiety and Depression Scale – German version), at 8 months after study enrollment 5- Dependency and functional impairment of the patient, measured using the Barthel Index (Barthel Index), the I-ADL (Instrumental Activities of Daily Living), and the mRS (modified Rankin Scale), at 8 months after study enrollment 6- Functionality, effectiveness, and acceptance of the new care model assessed through a mixed-methods process evaluation (quantitative and qualitative) among patients, caregivers, and healthcare providers, 8 months after study inclusion. 7- Economic evaluation, including cost-effectiveness and cost-utility analyses, based on a health-economic analysis of primary and secondary data, conducted 8 months after study inclusion. | — |
Countries
Germany
Contacts
Public ContactSarah Rudolph
Mobil Krankenkasse
Outcome results
None listed