Effectiveness of iSupport for unpaid carers of people with dementia: a randomized controlled trial

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1) Be aged 18 years or older; 2) Be an informal caregiver (partners, children, friends, etc) of a person with dementia for at least 6 months and experience at least some caregiver burden. This is assessed with one item on which the person can score the burden between 1 (no burden) and 10 (extreme burden). People with a score of 4 or higher will be included; 3) Well‐being needs to be affected and might be expressed as stress, depressive symptoms or anxiety. This mean that people need to have a score of > 13 on the Perceived Stress Scale (PSS) or a score =4 on the General Anxiety Disorder Questionnaire (GAD‐7)), or a score =4 on the Centre for Epidemiological Studies Depression scale (CES‐D); 4) The care recipient has to have a confirmed diagnosis of dementia (through self‐report of the caregiver) or a score =2 on the Ascertain Dementia 8‐item Informant Questionnaire (AD8). Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 1) Those receiving psychological treatment from a mental health specialist at the time of recruitment; 2) Being unable to comprehend written Dutch; 3) No access to internet. Online Support Programme, Dementia The trial contains two arms: (1) iSupport and (2) a comparison group which will receive a minimal intervention which consists of psycho‐education about dementia. ‐iSupport: iSupport is an online support programme to enhance self‐help, skills, and support for caregivers of people with dementia. The iSupport online intervention is based on the principles of Cognitive Behavioral Therapy (CBT), and includes techniques like problem solving, relaxation, and cognitive reframing. iSupport consists of twenty‐three lessons, distributed over five modules: What is Dementia? (1 lesson); Being a caregiver (4 lessons); Caring for Me (3 lessons); Providing everyday care (5 lessons), and; Dealing with Challenging Behaviour (10 lessons). Each caregiver can choose which lessons they like to do, depending on their needs, and when they like to complete them. The program will be available via personal computers and tablets. ‐Minimal intervention (Comparison condition): Participants assigned to comparison group will receive psycho‐education about dementia and caregiver stress. This is based on information provided by Alzheimer Nederland. This information will be made avalaible online (eBook) and in printed format. Caregivers can choose which format they prefer. Next to this psycho‐education caregiver are allowed to receive care‐as‐usual. They can search for other information or seek help from other providers. After the last assessment, 6 months after baseline, the caregivers in this group will be offered to access to iSupport. The main study parameter will be caregivers’ stress at post‐intervention. This will be measured with the Perceived Stress Scale (PSS). The secondary study parameters can be grouped into four categories. First, mental health outcomes. This includes: symptoms of depression (Centre for Epidemiological Studies Depression scale (CES‐D)), symptoms of anxiety (General Anxiety Disorder Questionnaire (GAD‐7)), and caregiver burden (Zarit Burden Scale (ZBS). The second category of outcomes relate to the way caregivers perceive that they can cope with the situation and the person with dementia. It includes: general sense of mastery (Pearlin Mastery Scale), self‐efficacy (RIS) which relate to the feeling that one can perform a certain task in a given situation competently and capably, sense of competence (Short Sense of Competence Questionnaire (SSCQ)) of the caregiver to care for the person with dementia, and the way the caregiver approaches the person with dementia (ADQ) which measures specifically if the caregiver can see the person with dementia as a unique and valuable person. The third category of outcomes relate to the costs. It contains a questionnaire measuring the health care use and (loss of) work productivity. These outcomes can be expressed in monetary units. All possible outcomes of the EQ5D, which measures quality of life, can be expressed as utilities (values). Combining monetary costs and utilities will enable us to perform cost‐utility analysis. The last category of outcomes relate to the intervention itself. It consists of usability (System usability scale (SUS)) which evaluates the satisfaction about the intervention as a whole. Next to this we will measure satisfaction with every lesson but this is incorporated into the intervention itself. Finally, we will gather data about the number of logins and the time spend on the intervention as indicators of intervention adherence.