Title: A randomised controlled trial and feasibility study of the effects of an e-health intervention ‘iSupport’ for reducing distress of dementia carers, especially in the ongoing pandemic of COVID-19.
Funder: Health and Care Research Wales (Welsh Government)

Abstract: NHS guidelines recommend informal carers of people living with dementia such as family and friends should be offered training to help them develop care skills and manage their own physical and mental health. The World Health Organisation recommend access to affordable, proven, well-designed, online technologies for education, skills training and support for dementia carers._x000D_ In response to these recommendations, we will carry out the first study in the UK of the benefits of an online training and support programme. This was developed by the World Health Organisation and is called ‘iSupport’. It is designed for dementia carers to help them provide good care and take care of themselves. Carers can use iSupport at their own pace. They can access whichever parts of iSupport they feel are most relevant to them from their place of choice using a computer or tablet._x000D_ We will do this research with the help of 356 dementia carers in England, Wales and Scotland by:_x000D_ 1. Examining the effectiveness of iSupport in reducing distress. Half of the carers will complete iSupport and half will receive information leaflets. All the carers will answer questionnaires about stress and strain, mental health, resilience and knowledge of dementia. They will do this three times over a six month period. By comparing the two groups, we will be able to show whether iSupport is better than simply giving information. _x000D_ 2. Understanding what aspects of iSupport carers like the most, and what might put them off using it. We will undertake interviews with a smaller group (50) of the carers and have a longer discussion about their thoughts, feelings and the impact of iSupport on themselves. They will do this three times over a six month period._x000D_ 3. Examining the potential costs and benefits of iSupport. This will involve carers answering questions about health and social care service use and their quality of life. They will do this three times over a six month period._x000D_ 4. Adapting iSupport for young carers (age 11-17). There are currently no evidence-based support interventions for young carers of people with dementia. We will work with a group of young carers and adapt iSupport for their use, identify what outcomes are most important to them, and assess this new version of iSupport with 30 young carers._x000D_ It is important we do this work because most people living with a dementia are cared for at home, supported by a family member or friend who has limited knowledge of the condition. The role is very stressful, and many carers experience more mental and physical illness compared to people who are not dementia carers. Covid-19 has meant that many older people have to self-isolate, placing increasing pressures on carers. _x000D_ If we show iSupport helps carers, service providers will benefit by knowing there is a proven service they can recommend to dementia carers. Carers will benefit from reductions in psychological distress and improvements in skills and resilience. People living with dementia will benefit from a better equipped carer. Society will potentially benefit from reduced care costs, as improving care at home can delay care-home admission. _x000D_ From the very start of the study, we will develop a comprehensive plan for ensuring our findings are communicated to people who need to hear about them. We will do this together with our collaborators, who include people living with dementia, carers, as well as academics, clinicians, charities and the World Health Organisation.

Lay abstract: Background: Most of the 850,000 people living with dementia in the UK are cared for at home. Caregiving is known to have a detrimental effect on physical and mental health. Covid-19 has meant that many older people have to self-isolate, placing increasing pressures on carers. NICE recommend informal carers of people living with dementia should be offered training and psychoeducation to help them develop care skills and manage their own physical and mental health. _x000D_ Research question: Is carer distress significantly reduced in participants allocated to receive the iSupport e-health intervention compared to carers allocated to a control group?_x000D_ Objectives_x000D_ 1)To estimate the clinical and cost-effectiveness of the iSupport intervention, compared with brief advice_x000D_ 2)To undertake a process evaluation of the barriers and facilitators to the implementation of ‘iSupport’ at scale/_x000D_ 3)To explore the feasibility of adapting iSupport for young carers_x000D_ Intervention: iSupport’ is an internet-based psychoeducation skills development intervention. It consists of five themes and accompanying exercises; (i) introduction to dementia; (ii) being a carer; (iii) caring for me; (iv) providing everyday care; and (v) dealing with behaviour changes. Each session takes approximately 5-15 minutes. Carers can construct their own personalised plan and access which sessions they feel are most relevant to them at that point in time. _x000D_ Design: Individually randomised two-arm controlled trial with health economic evaluation and nested process evaluation. A separate non-randomised feasibility study of adapting the intervention for young carers. The research will take place with carers living in the UK. The study will start 1.01.2021 and run for 36 months. _x000D_ The RCT will recruit 356 informal carers (aged 18+) of a person with dementia, caring at least weekly at home for at least 6 months. The carers must self-identify as experiencing at least some stress, anxiety or depression. Participants assigned to the comparison group will receive information about dementia developed by the Alzheimer’s Society. The feasibility study will involve 30 carers aged 11-17._x000D_ The primary outcome will be reduction in carers’ distress, as measured by the Zarit Interview (ZBI). Secondary outcomes assess reductions in depression (CESD-10), anxiety (GAD-7) improvements in resilience (RS-14), sense of competence (SSCQ), quality of the carer-patient relationship (QCPR), increases in dementia knowledge (DKAS) and the EQ-5D-5L._x000D_ Impact: This will be the first study in the UK and the first in an English-speaking population of a globally targeted e-health intervention for dementia carers. iSupport may be especially important in the current climate of distancing and isolating, and benefit the mental health of dementia carers in the UK, who may feel better able to provide care. New knowledge regarding what may enhance or hinder the implementation of iSupport will be of benefit to our collaborators at the WHO by informing the international implementation of iSupport. In the long term, we envisage sustainability with ‘iSupport’ embedded and recommended as part of care packages in the UK. Given that there are 850,000 people diagnosed with dementia in the UK, and most of them live at home supported by a family member or friend, the number of carers that could benefit is substantial. This may lead to reductions in care home admissions and reductions in health and social care costs, benefiting the economy.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH