About this trial
Health enSuite Caregivers is an e-health program designed to meet some of the most common needs of caregivers of persons with dementia, including information about dementia and dementia care, caregivers' emotional health, formal or informal help received from others. It also recommends specific strategies to promote wellbeing and provides tools to help caregivers implement these strategies in their everyday lives. Health enSuite Caregivers is available online and as a smartphone app. Its development was informed by reviews of caregivers' needs and existing commercially available apps F. A systematic search of commercially available smartphone applications for caregivers found that many apps did not consider each caregiver's unique needs and were limited to psychoeducational content (no tools for self-management). Furthermore, most existing programs have not been rigorously tested or lack evidence to support their effectiveness.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The participant is 18 years or older.
The participant has regular access to an internet connected device (e.g., smartphone, tablet, or computer).
The participant is a caregiver of a person with moderate dementia.
The participant provides a least one hour of care per week.
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Health enSuite Caregivers
BehavioralAdvice within Health enSuite Caregivers is organized into 5 priority areas: Taking Care of Yourself (Self-care), Support for You (Support), Supporting the Person Living with Dementia (Characteristics of Persons Living with Dementia), Communication, and Time Management. Under "My Priority Areas", participants will see these in order from highest to lowest need, based on their answers to the needs assessment. Each priority area contains small subtopics and specific tips for things to "Try" or "Avoid". Navigation through the priority areas is user directed and at the participant's discretion. The goal is to make the information they need easy to access.
Treatment groups
Trial outcomes
Primary outcomes
Carer wellbeing
Carer wellbeing in terms of emotional health and interpersonal relationships will be assessed as the primary outcome measure in this study using the Carer Wellbeing and Support Scales (CWS(9). It is recommended as the most appropriate instrument for the assessment of quality of life in informal carers of people with dementia (10). The CWS evaluates the multiple facets of well-being of people caring for someone with dementia. The aggregate of the responses to the questions under "your role as a carer", "your relationship with the person you care for", "your relationship with family and friends" and "your emotional well-being" will be used as the primary outcome in this RCT as these are the forms of wellbeing Health enSuite Caregivers is hypothesized to effect most strongly.
Secondary outcomes
Overall carer wellbeing and specific facets of carer welling
Responses on the CWS will be used to compute several secondary outcomes that may be affected by Health enSuite Caregivers. * Total carer wellbeing (sum of all 33 items) * Your role as a carer (items 1-5) * Relationship with the PWD (items 6-11) * Relationships with friends and family (items 12-15) * Emotional wellbeing (items 21-26) * Financial wellbeing (items 16-18) * Physical health (items 19-20) * Stigma and discrimination (item 27) * Personal safety (item 28-29) * Safety of PWD (items 30-32)
Self-efficacy
Caregiver self-efficacy will be measured using the family caregivers' self-efficacy for managing dementia scale (11). It measures the degree of confidence caregivers have about their ability to complete necessary caregiving tasks. It includes 10 items and is scored based on a 10-point Likert scale from 1 ("not at all certain") to 10 ("very certain"). This scale has been widely used in studies of caregivers of people with dementia and has been found to have good internal consistency (11-13).
Psychological distress
The Distress Questionnaire-5 (DQ-5) (18) will be used to assess psychological distress among caregivers. This 5-item measure captures general emotional distress and has demonstrated strong psychometric properties. We hypothesize that participants assigned to the intervention group will report lower levels of psychological distress at both 2- and 5-months post-randomization compared to participants in the control group. Specifically, DQ-5 scores are expected to decrease from baseline to follow-up in the intervention group, reflecting a reduction in emotional distress over time.
Locations
Sponsors and contacts
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