ReStoRe4stroke: Longitudinal Cohort study on psychosocial functioning in stroke patients and their partners
- Conditions
- Cerebrovascular AccidentStroke1000796310047075
- Registration Number
- NL-OMON41618
- Lead Sponsor
- Revalidatiecentrum De Hoogstraat
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 500
Inclusion criteria patient:
1). Symptomatic stroke (ischemic or intracerebral haemorrhagic lesion), if possible verified by CT and/or MRI scan.
2). Age at least 18 years.
3). Written informed consent. ;inclusion criteria partner:
1). The partner must be married or live together with the patient.
2). The partner (patient) must participate in the study.
Exclusion criteria patient:
1). Insufficient command of the Dutch language in order to participate and understand questionnaires, based on clinical judgement.
2). Pre-existent dependence in activities of daily living as defined by a pre-morbid Barthel Index below 18.
3.) pre-existent cognitive decline as defined by a score of 1 or higher on the HAC (Heteroanamnesis List Cognition).
4). Co-morbidity: A serious condition whereby an interference with the outcomes of the study is expected, (such as a psychiatric disorder whereby a person is under supervision of a psychiatrist or a serious cardiac disease), or a disease with a progressive course (such as cancer, arthritis, multiple sclerosis, dementia) or a life-threatening condition resulting in a life expectancy less than 6 months (such as a high risk of death from stroke or terminal kidney insufficiency).;Exclusion criteria partner:
1). Insufficient command of the Dutch language in order to participate and understand questionnaires, based on clinical judgement.
2). Pre-existent dependence in activities of daily living as defined by a pre-morbid Barthel Index below 18.
3). Co-morbidity: A serious condition whereby an interference with the outcomes of the study is expected, (such as a psychiatric disorder whereby a person is under supervision of a psychiatrist or a serious cardiac disease), or a disease with a progressive course (such as cancer, arthritis, multiple sclerosis, dementia) or a life-threatening condition resulting in a life expectancy less than 6 months (such as a high risk of death from stroke or terminal kidney insufficiency).
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome of this study is participation of stroke patients.<br /><br>Participation will be measured with the Utrecht Scale for Evaluation of<br /><br>Clinical Rehabilitation - Participation (USER-P).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes of this study are: quality of life, life satisfaction and<br /><br>emotional functioning of stroke patients and their partners.<br /><br><br /><br>These outcomes will be measured with the following measurements:<br /><br>-Quality of Life will be assessed by two measures. The first measure assesses<br /><br>stroke health-related quality of life (short Stroke Specific QoL<br /><br>Questionnaire,SS-QoL-12). The second measure assesses generic health-related<br /><br>quality of life in terms of utilities (Six Dimension Euro-QoL instrument,<br /><br>EQ-6D).<br /><br>-Life Satisfaction will be assessed with three questions which ask for<br /><br>satisfaction with life before the stroke, now and a comparison between before<br /><br>and now.<br /><br>-Emotional functioning will be assessed in terms of depression and anxiety<br /><br>(Hospital Anxiety and Depression Scale, HADS)</p><br>