Clinical trial NCT04944420: Health enSuite Caregivers: an App-based Treatment for Distressed Caregivers of Persons With Moderate Dementia
Official title: Evaluating an App-based Treatment for Distressed Caregivers of Persons With Moderate Dementia: Health enSuite Caregivers Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Caregiver Burnout
Keywords: Caregiver Burnout
Caregiver Stress
Caregivers
Dementia
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
First posted: 2021-06-29
Enrollment: 430
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This project consists of a pragmatic randomized controlled trial. Participants will be randomly allocated in a 1:1 ratio to either the intervention group or a wait-list control group. Participants in both groups will complete self-assessments, including key outcome measures, at baseline, and 3 and 6 months post-randomization. Participants in the intervention group will receive the full Health enSuite Caregivers program immediately after being randomized to this group.

Participants in the control group will be wait-listed and receive only treatment as usual during the study. After their participation is the study has ended, participants in the control group will be given access to the full Health enSuite Caregivers program.
Primary purpose: TREATMENT

Brief summary: 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 well-being 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. 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.

Detailed description: As the Canadian population ages, the demand for informal caregivers is expected to increase. Currently, an estimated 8 million Canadians provide unpaid assistance and ongoing care to family members and friends in need of support due to physical, cognitive, or mental health conditions. Challenges associated with being an informal caregiver vary based on a number of factors including how much time is involved, the health of the person being cared for, and the care needs. Although all caregivers may experience distress, caregivers of people with dementia are at especially high risk for psychological distress and poor health outcomes. Nearly half of the individuals who are providing care for someone with dementia experience symptoms of distress. It is important to provide caregivers with information and support so that they can manage these demands without compromising their own well-being. However, existing programs for caregivers are relatively limited. Primary care providers play an important role in supporting caregivers of people with dementia; however, there is a lack of effective, easily accessible programs for primary healthcare providers to recommend to a distressed caregiver of someone with dementia. The investigators developed Health enSuite Caregivers as a potential solution to this problem.

Primary hypothesis: On average participants assigned to the intervention group will report greater wellbeing (emotional and relationship facets) over time compared to participants assigned to the control group. At 3 and 6 months post-randomization emotional and relational well-being is expected to be higher in the intervention group compared to the control group. Secondary hypothesis: Participants assigned to the intervention group will have greater well-being (each specific facet, total well-being) and greater self-efficacy at 3 and 6 months post-randomization compared to participants assigned to the control group.

This project consists of a pragmatic randomized controlled trial (RCT). Participants will be randomly allocated in a 1:1 ratio to either the intervention group or a wait-list control group. Participants in both groups will complete self-assessments, including key outcome measures, at baseline, and 3, and 6 months post-randomization. Participants in the intervention group will receive the full Health enSuite Caregivers program immediately after being randomized to this group. It is designed to offer advice to caregivers of persons with dementia based on an assessment of their specific needs. Topics are divided into five main content areas, which are recommended based on an assessment of the caregivers current challenges and sources of stress. Participants in the control group will be wait-listed and receive only treatment as usual during the study. After their participation is the study has ended, participants in the control group will be given access to the full Health enSuite Caregivers program.

Eligibility criteria: Inclusion Criteria:

Caregiver Eligibility Screening:

Part 1:

1. Are you 18 years and older?

   * Yes
   * No
2. Do you have regular access to an Internet connected device (tablet, computer, smartphone)?

   * Yes
   * No

   As their disease progresses, persons living with dementia will experience changes in their memory and judgment. These changes will impact their ability to complete many tasks and activities independently.
3. Does the person with dementia you are caring for need assistance, encouragement or reminders to complete any of the following activities because of memory or thinking problems?

   Assistance with activities such as:
   * Cooking
   * House or yard work
   * Using the telephone
   * Driving
   * Managing finances
   * Managing medications
4. Encouragement or reminders to complete such activities as:

   * Bathing
   * Getting dressed
   * Walking
   * Using the toilet
   * Eating
5. How many hours in a week are you providing care for this person with dementia?

   * more than 1 hour per week -less than one hour per week

Part 2:

In the past 30 days:

1. My worries overwhelm me

   * Never (1)
   * Rarely (2)
   * Sometimes (3)
   * Often (4)
   * Always (5)
2. I felt hopeless

   -Never (1)

   -Rarely (2)

   -Sometimes (3)

   -Often (4)

   -Always (5)
3. I found social settings upsetting

   * Never (1)
   * Rarely (2)
   * Sometimes (3)
   * Often (4)
   * Always (5)
4. I had trouble staying focused on tasks

   -Never (1)
   * Rarely (2)
   * Sometimes (3)
   * Often (4)
   * Always (5)
5. Anxiety or fear interfered with my ability to do the things I needed to at work or at home

   * Never (1)
   * Rarely (2)
   * Sometimes (3)
   * Often (4)
   * Always (5)

Determination of eligibility:

• If response to the question 1 is Yes, the application will consider the caregiver as eligible. If response to the question 1 is No, then application displays this message to the caregiver "You are currently not eligible to participate in this study. This application is designed to support caregivers who are 18 years and older."

* If response to the question 2 is Yes, the application will consider the caregiver as eligible. If response to the question 2 is No, then application displays this message to the caregiver "You are currently not eligible to participate in this study. To access the Health enSuite Caregivers program you will need regular access to a device with an internet connection."
* If at least 1 option from question 3 or question 4 is selected, then person is considered to be living with "moderate" dementia, and the application will consider the caregiver as eligible. If no option from question 3 or question 4 is selected, then the application will consider the caregiver as ineligible, and display the following message to the caregiver "You are currently not eligible to participate in this study. You must be caring for a person with moderate dementia to be able to participate in the Health enSuite Caregivers program."
* If "more than one hour per week" is selected for question 5 then the application will consider the caregiver as eligible. If "less than one hour per week" is selected, then the application will consider the caregiver as ineligible, and display the following message to the caregiver "You are currently not eligible to participate in this study. You must be caring for a person with moderate dementia for more than 1 hour per week to be able to participate in the Health enSuite Caregivers program."

Part 2:

• If sum of responses in Part 2 is 10 or less, then the participant is ineligible. If the sum of response in Part 2 is 11 or greater, then the participant is ineligible.

Exclusion Criteria:

-

Primary outcomes:
measure: Change in carer emotional and relationship well-being at 3 and 6 months
timeFrame: Baseline assessment, 3 months post randomization, 6 months post randomization
Secondary outcomes:
measure: Change in total carer wellbeing at 3 and 6 months
timeFrame: Baseline assessment, 3 months post randomization, 6 months post randomization
measure: Change in carer concern toward their role as a carer at 3 and 6 months
timeFrame: Baseline assessment, 3 months post randomization, 6 months post randomization
measure: Change in carer relationship with the person with dementia at 3 and 6 months
timeFrame: Baseline assessment, 3 months post randomization, 6 months post randomization
measure: Change in carer relationships with friends and family at 3 and 6 months
timeFrame: Baseline assessment, 3 months post randomization, 6 months post randomization
measure: Change in carer emotional well-being at 3 and 6 months
timeFrame: Baseline assessment, 3 months post randomization, 6 months post randomization
measure: Change in carer financial well-being at 3 and 6 months
timeFrame: Baseline assessment, 3 months post randomization, 6 months post randomization
measure: Change in carer physical health at 3 and 6 months
timeFrame: Baseline assessment, 3 months post randomization, 6 months post randomization
measure: Change in carer experience with stigma and discrimination at 3 and 6 months
timeFrame: Baseline assessment, 3 months post randomization, 6 months post randomization
measure: Change in carer personal safety at 3 and 6 months
timeFrame: Baseline assessment, 3 months post randomization, 6 months post randomization
measure: Change in safety of the person with dementia at 3 and 6 months
timeFrame: Baseline assessment, 3 months post randomization, 6 months post randomization
measure: Change in carer distress at 3 and 6 months
timeFrame: Baseline assessment, 3 months post randomization, 6 months post randomization
measure: Change in carer self-efficacy at 3 and 6 months
timeFrame: Baseline assessment, 3 months post randomization, 6 months post randomization
Other outcomes:
Locations:
Study officials:
affiliation: IWK Health Centre
name: Patrick McGrath
role: PRINCIPAL_INVESTIGATOR
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