Telephone-based behaviour-therapeutic intervention to reduce family caregiver burden in chronic stroke (Telefongestützte verhaltenstherapeutische Intervention zur entlastung Pflegender angehöriger von Schlaganfall-betroffenen)
- Conditions
- Burden of family caregivers of chronic stroke survivorsCirculatory SystemCerebrovascular diseases
- Registration Number
- ISRCTN86289718
- Lead Sponsor
- Robert Bosch Hospital (Robert-Bosch-Krankenhaus) (Germany)
- Brief Summary
2014 results in: https://www.ncbi.nlm.nih.gov/pubmed/24911421 (added 11/07/2019)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 122
Care recipient:
1. 60 years or older at the time moment of index stroke* (loss of neurological function due to an ischaemic or haemorrhagic intracranial vascular event)
2. Formal need of care or help for at least 1.5 hours a day (10.5 hours per week) (this time criteria corresponds to the criteria for receiving benefits from the statutory German nursing insurance), or
3. Need of care in form of supervision or for care recipients with cognitive impairment for at least 1.5 hours a day (10.5 hours per week) (these people are currently not adequately considered by the statutory German nursing insurance, but might be in the future)
Caregiver:
1. Age: 18 years and older
2. Family member, who has cared for the stroke survivor for at least six months
3. Time spent with care of stroke survivor (including nursing care, supervision and contact) at least 1.5 hours per day or 10.5 hours per week. There can be additional support with care (e.g. professional community nurses)
4. Significant caregiver burden assessed with six screening questions
5. Living in the region of Stuttgart (maximum of one hour with public transport from the study centre)
6. Availability of a telephone extension
7. At enrolment, plan to remain in area for the duration of the intervention
8. Ability to communicate over the telephone
* In the case of recurring strokes the index stroke is defined as the last stroke that increases the demand of care in a significant way
Care recipient:
1. Planned nursing home placement within the next six months
2. Unstable or progressive severe disease
3. Terminal status based on a prognosis of less than six months
Caregiver:
1. Duration of caregiving for the stroke survivor more than five years after index stroke
2. Mental disease like schizophrenia, alcohol addiction or cognitive impairment (rapid dementia screening test less than nine points)
3. Severe and unstable or progressive diseases like cancer
4. Not able to understand and speak German language
5. Temporary increased caregiver burden because of an acute illness (greater than repetition of the screening after such an episode of increased burden)
6. Involved in another clinical trial of interventions for caregivers (non-drug study)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Subjective caregiver burden (Sense of Competence Questionnaire [SCQ])<br> 2. Caregiver depression (the Centre for Epidemiological Studies Depression scale [CES-D])<br> 3. Total costs of formal and informal care<br> 4. Indirect costs<br><br> Measured at:<br> T0 (Agreement) primary and secondary outcomes<br> T1 (3 ½ months after T0) primary and secondary outcomes<br> T2 (12 months after T0) primary and secondary outcomes<br> T3 (24 months after T0) and T4 (36 months after T0) institutionalisation rates<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Ability of social problem solving<br> 2. Social activities<br> 3. Social support<br> 4. Subjective physical symptoms<br> 5. Burden of behavioural symptoms<br> 6. Subjective health related quality of life<br> 7. Qualitative analysis of caregiver burden with description of main problem areas with the card set<br> 8. Institutionalisation rates of care recipients over a prolonged observational period<br><br> Measured at:<br> T0 (Agreement) primary and secondary outcomes<br> T1 (3 ½ months after T0) primary and secondary outcomes<br> T2 (12 months after T0) primary and secondary outcomes<br> T3 (24 months after T0) and T4 (36 months after T0) institutionalisation rates<br>