Skip to content

ReStoRe4stroke: Longitudinal Cohort study on psychosocial functioning in stroke patients and their partners

ReStoRe4stroke: Longitudinal Cohort study on psychosocial functioning in stroke patients and their partners - ReStoRe4stroke

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON41618
Enrollment
500
Registered
2011-02-07
Start date
2011-03-22
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebrovascular Accident Stroke

Interventions

None listed

Sponsors

Revalidatiecentrum De Hoogstraat
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria: 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).

Design outcomes

Primary

MeasureTime frame
The primary outcome of this study is participation of stroke patients. Participation will be measured with the Utrecht Scale for Evaluation of Clinical Rehabilitation - Participation (USER-P).

Secondary

MeasureTime frame
Secondary outcomes of this study are: quality of life, life satisfaction and emotional functioning of stroke patients and their partners. These outcomes will be measured with the following measurements: -Quality of Life will be assessed by two measures. The first measure assesses stroke health-related quality of life (short Stroke Specific QoL Questionnaire,SS-QoL-12). The second measure assesses generic health-related quality of life in terms of utilities (Six Dimension Euro-QoL instrument, EQ-6D). -Life Satisfaction will be assessed with three questions which ask for satisfaction with life before the stroke, now and a comparison between before and now. -Emotional functioning will be assessed in terms of depression and anxiety (Hospital Anxiety and Depression Scale, HADS)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)