Topic: Stroke
Conditions
Interventions
Current interventions as of 09/06/2017:
1. Treatment intervention group: There will be 4 intervention groups of approximately 5 participants. Groups will be held in a non-clinical envi
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| As this is a feasibility trial, we have no pre-defined outcome measure at present. The measures will pertain to the feasibility aims of the study. We will test the feasibility, tolerability and acceptability of delivering the intervention and will record data on study completion and attrition. At baseline the following measurement data will be collected with stroke patients: 1. At baseline we will collect demographic details of patients including age, gender, ethnicity and employment. 2. Language and Cognitive Abilities (Montreal Cognitive Assessment) 3. Personal Activities of Daily Living (Barthel Index) 4. Stroke severity (National Institute of Health Stroke Scale) 5. Which service (if any) the patient is discharged to (e.g. ESD, intermediate care) 6. Number and percentage of participants who meet eligibility criteria 7. Number of eligible participants who give consent Questionnaires to be completed face-to-face, with both patients at baseline, 6 months after recruitment include: 1. To assess levels of anxiety and depression: Hospital Anxiety and Depression Scale 2. To assess functional health and wellbeing: Rand SF36 3. To assess Quality of Life: EuroQol to assess quality of life Additional questionnaires to be completed with just patients include: To assess level of dependence: Modified Rankin Scale Measures at two and four months: 1. Number and percentage of people who completed each outcome measures at 6 month follow-up 2. Number of times RA is unblinded to intervention and description of how this occurred 3. Number and percentage of patients who died, including date of death and cause of death 4. Number and percentage of hospital readmissions (whether gene | — |
Countries
United Kingdom
Outcome results
None listed