ReStoRe: Clinical and cost-effectiveness of self-management strategies in stroke patients and their partners
- Conditions
- Cerebrovasculair Accidentstroke10007963
- Registration Number
- NL-OMON38360
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 170
The inclusion criteria of this study for stroke patients are:
(1) Clinical diagnosed symptomatic stroke (ischemic or intracerebral haemorrhagic
lesion), first or recurrent, if possible verified by Magnetic Resonance Imaging (MRI) and/ or
Computed Tomography (CT) data;
(2) reporting problems in social reintegration represented by at least two scores
indicating experienced participation restrictions in activities in daily life on the Utrecht
Scale for Evaluation of Rehabilitation-participation*s restriction scale (USER-P) ;
(3) Living at home;
(4) at least 6 weeks post stroke;
(5) Age at least 18 years;
(6) Written informed consent. ;The inclusion criteria of this study for partners are:
(1) Living together with a stroke patient participating in the study;
(2) Age at least 18 years;
(3) Written informed consent.
Exclusion criteria of this study for the stroke patients are:
(1) An insufficient mental ability to understand, learn from and profit from the self-management
treatment on the basis of clinical judgement of the recruiting physician;
(2) Inability to function in a group because of behavioural problems as assessed by
clinical judgement of the recruiting physician;
(3) Insufficient command of the Dutch language communication abilities
(score < 5 on the Shortened version of the Aphasia Scale of the Dutch Foundation);
(4) Having a major depression based on clinical judgement;
(5) participating in structured, psychological counselling aimed at coping or self management
post stroke at moment of recruitment.;Exclusion criteria for the partners are:
(1) Inability to function in a group based on clinical judgement of the recruiting physician;
(2) Insufficient command of the Dutch language based on clinical judgement;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameters will concern patients* and partners* appraisals of<br /><br>their proactive coping competencies and participatione. Proactive coping will<br /><br>be measured with the Utrecht Proactive Coping Competence Scale, UPCC, for<br /><br>patient and partner. Participation in society in terms of subjective<br /><br>experienced restriction will be measured with the restriction subscale Utrecht<br /><br>Scale for Evaluation of Rehabilitation-Participation, USER-P.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary parameters of the study will concern self-efficacy measured with the<br /><br>General Self Efficacy Scale (GSES), participation in society in terms of<br /><br>objective frequency and subjective satisfaction measured with the USER-p<br /><br>frequency and satisfaction subscales, life satisfaction with three Visual<br /><br>Analogue Scales (3 questions), health related quality of life measured with the<br /><br>Short Stroke-Specific Quality of Life scale (SSQoL-12), general quality of life<br /><br>measured with the Six Dimensional EuroQoL (EQ-6D), care-related quality of life<br /><br>measured with the CarerQol questionnaire, emotional functioning with the<br /><br>Hospital Anxiety and Depression Scale (HADS), and caregiver burden measured<br /><br>with the expanded Cargiver Strain Index (CSI+).</p><br>