Reductions in psychological distress and improvements in skills and resilience in dementia carers Mental and Behavioural Disorders
Conditions
Interventions
WS1 is a multi-centre, pragmatic, single-blinded, two-arm randomized controlled trial (RCT) with an internal pilot. Randomization through a secure online system employing a dynamic randomisation algor
Sponsors
Bangor University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: WS1 & WS3 Dementia carers (age 18+ years): 1. Self-identify as an unpaid carer (partners, children, friends, etc.) of a person with dementia who is not living in a full-time care facility, caring at least weekly for at least 6 months 2. Self-identify as experiencing at least some stress, depression or anxiety 3. The care recipient has to have a confirmed diagnosis of dementia (through self-report by the carer, to reflect the ‘real world’ application of iSupport) WS2 PROCESS EVALUATION will run alongside WS1 to undertake a mixed-methods exploration in line with Medical Research Council guidance. It will assess the implementation of iSupport, the participant’s perspectives of the intervention, including the barriers, facilitators and perceived benefits, and theorize mechanisms of change WS4 Young dementia carers (age 11-17 years): 1. Young people between the age of 11-17 years (secondary school age) who self-identify as a carer of a person with dementia who is not living in a full-time care facility, caring at least weekly for at least 6 months 2. The care recipient has to have a confirmed diagnosis of dementia (through self-report by the carer, to reflect the ‘real world’ application of iSupport)
Exclusion criteria
Exclusion criteria: Trial exclusion criteria: 1. Receiving psychological treatment from a mental health specialist at the time of recruitment 2. Unable to comprehend written English 3. No access to the internet 4. Unable to give informed consent to the trial 5. Have previously used iSupport materials (in the last 12 months) Feasibility study (WS4) exclusion criteria: 1. Receiving treatment from Child and Adolescent Mental Health Services (CAMHS) at the time of recruitment 2. Unable to comprehend written English 3. No access to the internet 4. Have previously used iSupport materials (in the last 12 months)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| There will be two primary outcome measures for WS1. Sample size has been based on considering both outcomes as primary outcomes where a successful trial would be noted if at least one of the outcomes indicated a statistically significant effect. Both primary outcome measures will be administered at baseline (T0), 3 months after baseline (T1) and 6 months after baseline (T2): 1. Carers’ distress measured by the 12-item Zarit Burden Interview (ZBI-12) 2. Caregiver depression measured by the 10-item Centre for Epidemiological Studies of Depression Scale (CES-D 10) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 04/03/2024: 1. The frequency of common symptoms of anxiety assessed through the Generalised Anxiety Disorder Questionnaire (GAD-7) 2. Improvements in the way carers perceive they can manage the situation assessed through the Resilience Scale-14 (RS-14) 3. The influence of iSupport on the quality of the caregiving relationship assessed through the 14-item Quality of the Carer-Patient Relationship (QCPR) 4. Improvements in how the carer understands their relative assessed through the 25-item Dementia Knowledge Assessment Scale (DKAS) 5. Utility values for Quality-Adjusted Life Years obtained from responses to the EQ-5D-5L 6. Impact on the health-related quality of life of the person being cared for assessed through the DEMQOL-Proxy 7. Out of pocket expenses obtained through a Service Use Questionnaire developed for iSupport 8. Opportunity costs assessed through the iMTA Valuation of Informal Care Questionnaire The feasibility study (WS4) will adapt the standardised measures above based on focus group responses, and conduct the assessments with younger dementia carers at baseline (T0), 3 months after baseline (T1) and 6 months after baseline (T2). One measure, the Short Sense of Competence Questionnaire (SSCQ), was agreed with NIHR to remove from the case report form (CRF) due to overlap with other measures.. Measured at baseline (T0), 3 months after baseline (T1) and 6 months after baseline (T2): 1. The frequency of common symptoms of anxiety assessed through the Generalised Anxiety Disorder Questionnaire (GAD-7) 2. Improvements in the way carers perceive they can manage the situation assessed through the Resilience Scale-14 (RS-14) 3. The influence of iSupport on the quality of the caregiving relationship assessed through the 14-item Quality of the Carer-Patient Relationship (QCPR) 4. Improvements in how the carer understands their relative assessed through the 25-item Dementia Knowledge Assessment Scale (DKAS) 5. Utility | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactGregory Flynn
Outcome results
None listed