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Restore: Clinical and cost-effectiveness of self management strategies in stroke patients and their partners.

Restore: Clinical and cost-effectiveness of self management strategies in stroke patients and their partners.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23898
Enrollment
106
Registered
2011-08-30
Start date
2011-09-01
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

stroke, CVA (beroerte, CVA) partners, spouses (partners)

Interventions

The self management intervention will last ten weeks, with six two-hour group sessions in the first six weeks and one two-hour booster session one month later. During the sessions participants will pr
2. Social support and relations
3. Participation in society
4. Coping with negative feelings will be discussed. Elements of the intervention are: 1. Provision of information
3. Formulation of goals and action plans
4. Exercises and homework. Four stroke patients with their possible partners will be present (total of 4-8 participants). The group sessions will be led by two health care professionals of the partic
2. A stroke
3. Consequences of stroke
4. Prevention of stroke. Elements of the intervention are: 1. Provision of information
2. Homework. Four stroke patients with their possible partners will be present (total of 4-8 participants). The group sessions will be led by one health care professionals of the participating rehabi

Sponsors

University Medical Center Utrecht (UMCU)/ Maastricht University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The inclusion criteria of this study for stroke patients are: 1. Clinically 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 in society 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

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Patients' and partners' appraisals of their proactive coping competencies (assessed with the Utrecht Proactive Coping Competence list, the UPCC) and participation in society (assessed with the Utrecht Scale for Evaluation of Rehabilitation-Participation, the USER-P).

Secondary

MeasureTime frame
1. Patients' and partners' self-efficacy (assessed with the General Self Efficacy Scale, the GSES), general quality of life (measured with the Six Dimensional EuroQol, the EQ-6D), emotional functioning (assessed with the Hospital Anxiety and Depression Scale, the HADS); 2. Patients' health related quality of life (assessed with the Short Stroke-Specific Quality of Life scale, the SS-QoL-12) and life satisfaction (assessed with three questions). Partners' care related quality of life (assessed with the CarerQol) and experienced burden (assessed with the Expanded Caregiver Strain Index, the CSI+).

Contacts

Public ContactC. Heugten, van

PO Box 616

c.vanheugten@maastrichtuniversity.nl+31 (0)43 3884091

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)