ischemic stroke, after-care, societal participation, quality of life, cost-benefit analysis, cognition, emotion beroerte, herseninfarct, CVA-nazorg, nazorg, (maatschappelijke) participatie, kosteneffectitiveit, cognitie, emotie
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - clinical diagnosis of ischemic stroke as diagnosed by a neurologist after anamnesis, neurological examination and CT-brain or MRI-brain; - signs and symptoms resolve sufficiently to discharge subjects to their homes without the need for inpatient rehabilitation or follow-up care at the physiatry outpatient clinics.
Exclusion criteria
Exclusion criteria: - age below 18 years; - any serious comorbidity that 1) presumably interferes with the study outcomes (e.g. a psychiatric disorder wherefore supervision of an psychiatrist is needed), 2) has a progressive course (e.g. cancer, multiple sclerosis, and a diagnosis of mild cognitive impairment or dementia) or 3) has a life expectancy of less than 6 months; - transient ischemic attack defined as symptoms of a stroke that last less than 24 hours and are not accompanied with ischemic lesions in the corresponding vascular territory on CT-scan or MRI; - hemorrhagic stroke; - unable to understand questionnaires due to insufficient Dutch language proficiency or aphasia based on clinical judgement; ; - legally incompetent adults; - no informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be the level of participation measured with the Restriction subscale of the Utrecht Scale for Evaluation of Rehabilitation on the level of Participation (USER-P Restriction) at 1 year. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The following secondary outcome measures for clinical effectiveness will be used: cognitive complaints (Checklist for Cognitive and Emotional Consequences following stroke (CLCE-24)), depression and anxiety (Hospital Anxiety and Depression Scale (HADS)), quality of life (Six-Dimensional EuroQol (EQ-6D-5L)), patient-reported global health (PROMIS Global-10), physical disability (modified Rankin Scale (mRS)) and self-efficacy (General Self-Efficacy Scale (GSES)) at 1 year. Data will be collected at six weeks (T1), three months (T2) and 12 months (T3) after stroke. Besides, patient satisfaction will be measured by a customized version of the SASC-19 and will be completed at 3 months. 2. With regard to the economic evaluation, the quality of life will be measured with the EQ-5D-5L and the use of care and health-related costs will be assessed with the Medical Consumption Questionnaire (MCQ) and the Productivity Cost Questionnaire (PCQ). Data will be collected at 6 weeks, 3 months (T2) and 12 months (T3). 3. A process evaluation by a mixed methods study will be conducted parallel to the randomized controlled trial to establish the feasibility of the intervention by assessing performance according to protocol, attendance and adherence, and the opinion of patients, and professionals about the intervention. In this prospective mixed methods study, data will be gathered using questionnaires for patients, registration forms for professionals and by carrying out semi-structured interviews with patients and professionals. All materials will be developed specifically for this study and intervention. | — |
Contacts
OLVG Amsterdam