Biopsychosocial Intervention for Stroke Carers

Not Applicable

Completed

• Conditions: Topic: Stroke; Subtopic: Rehabilitation; Disease: Therapy type, Community study; Circulatory System

• Registration Number: ISRCTN15643456
• Lead Sponsor: niversity of Nottingham

Brief Summary

2017 protocol in https://pubmed.ncbi.nlm.nih.gov/29061630/ (added 23/09/2020) 2020 results in https://doi.org/10.1177/0269215520937039 (added 23/09/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-12
• Study Completion: 2018-03-31
• Last Update Posted: 5 October 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Current inclusion criteria as of 09/06/2017:
Phase 1: Development of Intervention
Carer Focus Groups:
1. Adult carers of stroke patients who have a confirmed diagnosis of stroke
2. Carers able to provide informed consent
Stroke expert clinicians and researchers:
1. Researchers and clinicians with significant experience (>3 years) of either working clinically or conducting research with stroke carers
Expert panellists have already been identified by the steering committee for invitation for this phase of study.

Phase 2: Feasibility Trial
Stroke patients:
1. Adult stroke patients who have a confirmed diagnosis of stroke
2. Stroke patients within one year of their stroke onset
3. Willingness of stroke survivor to be included in follow up assessments
4. Both patients and their carers must consent for their carer to take part in the study.
Stroke carers:
1. Adult carers of stroke patients who have a confirmed diagnosis of stroke
2. Carers of patients within one year of their stroke onset
3. Carers who are able to provide informed consent
4. Willingness to attend a behavioural programme of 6 weeks duration
5. Willingness of stroke survivor to be included in follow up assessments
6. Both patients (or their consultee) and their carers must consent for their carer to take part in the study.

Previous inclusion criteria:
Phase 1: Development of Intervention
Carer Focus Groups:
1. Adult carers of stroke patients who have a confirmed diagnosis of stroke
2. Carers able to provide informed consent
Stroke expert clinicians and researchers:
1. Researchers and clinicians with significant experience (>3 years) of either working clinically or conducting research with stroke carers
Expert panelists have already been identified by the steering committee for invitation for this phase of study.

Phase 2: Feasibility Trial
Stroke patients:
1. Adult stroke patients who have a confirmed diagnosis of stroke
2. Stroke patients within one year of their stroke onset
3. Stroke patients able to provide informed consent
4. Willingness of stroke survivor to be included in follow up assessments
5. Both patients and their carers must consent for their carer to take part in the study.
Stroke carers:
1. Adult carers of stroke patients who have a confirmed diagnosis of stroke
2. Carers of patients within one year of their stroke onset
3. Carers who are able to provide informed consent
4. Willingness to attend a behavioural programme of 6 weeks duration
5. Willingness of stroke survivor to be included in follow up assessments
6. Both patients and their carers must consent for their carer to take part in the study.

Exclusion Criteria

Current exclusion criteria as of 09/06/2017:
Phase 1: Development of Intervention
Carer Focus Groups:
1. People who do not speak English
Stroke expert clinicians and researchers:
1. People who do not speak English

Phase 2: Feasibility Trial
Stroke patients:
1. People who do not speak English
2. People engaged in other research involving behavioural interventions
Stroke carers:
1. People who do not speak English
2. People engaged in other research involving behavioural interventions
3. People with visual (blindness) or auditory (deafness) impairments that would preclude them from participating in the therapy sessions.

Previous exclusion criteria:
Phase 1: Development of Intervention
Carer Focus Groups:
1. People who do not speak English
Stroke expert clinicians and researchers:
1. People who do not speak English

Phase 2: Feasibility Trial
Stroke patients:
1. People who do not speak English
2. People engaged in other research involving behavioural interventions
3. People with visual (blindness) or auditory (deafness) impairments that would preclude them from participating in the therapy sessions.
Stroke carers:
1. People who do not speak English
2. People engaged in other research involving behavioural interventions
3. People with visual (blindness) or auditory (deafness) impairments that would preclude them from participating in the therapy sessions.

Study & Design

• Study Type: Interventional
• Study Design: Not specified