Effects of an e-health intervention ‘iSupport’ for reducing distress of dementia carers

INTERVENTION: 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 algorithm will allocate patients to the intervention or control‐comparison group. Participants assigned to the control‐comparison group will receive information about dementia developed by the Alzheimer’s Society. A 6‐month internal pilot will be nested in this WS at each site. Stop/Review/Go criteria will indicate the success of the participant recruitment targets (e.g. recruitment and set up/ training of sites within time allocated: Go: 3, Review: 2, Stop: 1. Recruitment of participants based on target of n=110 by month 6 of recruitment: Go:>=94 (85%), Review: 56‐93 (50 ‐ 84%), Stop: <=55 (<50%)). The study is guided by the ‘Context and Implementation of Complex Interventions’ checklist. WS2 PROCESS EVALUATION will run alongside WS1 and apply mixed‐methods (semi‐structured interviews, quantitative questionnaires and analysis of data from the online platform). It will be conducted in line with established guidance frameworks. It will examine throughout the intervention period how participants engage with and adhere to particular aspects of iSupport (e.g. most/least frequently visited pages, the most ‘popular’ modules/sessions, sessions with quizzes with the highest rates of wrong responses). A System Usability Scale will be administered at 6‐month follow up. This 10‐item scale will quantitatively evaluate the overall usability of the iSupport platform. Semi‐structured interviews will be undertaken using an internet‐based service (e.g. Zoom, Teams, Skype, or GoToMeeting) or telephone, with a sub‐sample of the intervention participants. These wil CONDITION: Reductions in psychological distress and improvements in skills and resilience in dementia carers ; Mental and Behavioural Disorders PRIMARY OUTCOME: ; 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 OUTCOME: ; 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. Sense of competence developed for dementia caregivers assessed through the 7‐item Short Sense of Competence Questionnaire (SSCQ); 4. The influence of iSupport on the quality of the caregiving relationship assessed through the 14‐item Quality of the Carer‐Patient Relationship (QCPR); 5. Improvements in how the carer understands their relative assessed through the 25‐item Dementia Knowledge Assessment Scale (DKAS); 6. Utility values for Quality‐Adjusted Life Years obtained from responses to the EQ‐5D‐5L; 7. Impact on the health‐related quality of life of the person being cared for assessed through the DEMQOL‐Proxy; 8. Out of pocket expenses obtained through a Service Use Questionnaire developed for iSupport; 9. 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).; 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 care