Health enSuite Caregivers: an App-based Treatment for Distressed Caregivers of Persons With Moderate Dementia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluating an App-based Treatment for Distressed Caregivers of Persons With Moderate Dementia: Health enSuite Caregivers Study

Conditions
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Caregiver Burnout

Intervention / Treatment
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* Behavioral: Health enSuite Caregivers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Caregiver Eligibility Screening: Part 1: Are you 18 years and older? Yes No 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. 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 Encouragement or reminders to complete such activities as: Bathing Getting dressed Walking Using the toilet Eating 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: My worries overwhelm me Never (1) Rarely (2) Sometimes (3) Often (4) Always (5) I felt hopeless -Never (1) -Rarely (2) -Sometimes (3) -Often (4) -Always (5) I found social settings upsetting Never (1) Rarely (2) Sometimes (3) Often (4) Always (5) I had trouble staying focused on tasks -Never (1) Rarely (2) Sometimes (3) Often (4) Always (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: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Intervention group will have access to Health enSuite Caregivers, 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 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. | Behavioral: Health enSuite Caregivers<br>* Advice 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.<br>|
| No Intervention: Waitlist Control<br>Participants in the control group will be wait-listed and receive only treatment as usual from their healthcare providers 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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in carer emotional and relationship well-being at 3 and 6 months | Primary objectives: Carer emotional and relationship well-being, (as assessed using the Carer Wellbeing Scales (CWS). The ratings to the CWS questions in the following sections: 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 aggregated to create a single composite score for each participant. This composite score will be the primary outcome measure. Each of the 21 items in these sections (items 1-5, 6-11, 12-15, and 21-26) can be answered using A lot (4) Quite a bit (3) Moderately (2) A little (1) or Not at all (0), with total scores on the scale ranging from 0-84), with higher scores indicating poorer emotional and relationship well-being. | Baseline assessment, 3 months post randomization, 6 months post randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total carer wellbeing at 3 and 6 months | All sections of the Carer Wellbeing and Support Scales (CWS) will be used as a secondary outcome measure, measuring the total change in carer well-being and support. Each of the 33 items in these sections can be answered using A lot (4) Quite a bit (3) Moderately (2) A little (1) or Not at all (0), with total scores on the scale ranging from 0-132, with higher scores indicating poorer total carer well-being. | Baseline assessment, 3 months post randomization, 6 months post randomization | 
| Change in carer concern toward their role as a carer at 3 and 6 months | The your role as a carer section (items 1-5) of the Carer Wellbeing and Support Scales (CWS) will be used as a secondary outcome measure, measuring the change in overall feeling toward their role as a carer Each of the items in these sections can be answered using A lot (4) Quite a bit (3) Moderately (2) A little (1) or Not at all (0), with total scores on the scale ranging from 0-20, with higher scores indicating higher carer concern toward their role as a carer. | Baseline assessment, 3 months post randomization, 6 months post randomization | 
| Change in carer relationship with the person with dementia at 3 and 6 months | The Relationship with the person with dementia section (items 6-11) the Carer Wellbeing and Support Scales (CWS) will be used as a secondary outcome measure, measuring the change in the carers relationship with the person with dementia. Each of the items in these sections can be answered using A lot (4) Quite a bit (3) Moderately (2) A little (1) or Not at all (0), with total scores on the scale ranging from 0-24, with higher scores indicating poorer carer relationship with the person with dementia. | Baseline assessment, 3 months post randomization, 6 months post randomization | 
| Change in carer relationships with friends and family at 3 and 6 months | The Relationships with friends and family section (items 12-15) of the Carer Wellbeing and Support Scales (CWS) will be used as a secondary outcome measure, measuring the change in relationships with friends and family. Each of the items in these sections can be answered using A lot (4) Quite a bit (3) Moderately (2) A little (1) or Not at all (0), with total scores on the scale ranging from 0-16, with higher scores indicating poorer carer relationships with friends and family. | Baseline assessment, 3 months post randomization, 6 months post randomization | 
| Change in carer emotional well-being at 3 and 6 months | The emotional well-being section(items 21-26) of the Carer Wellbeing and Support Scales (CWS) will be used as a secondary outcome measure, measuring the change in carer emotional well-being. Each of the items in these sections can be answered using A lot (4) Quite a bit (3) Moderately (2) A little (1) or Not at all (0), with total scores on the scale ranging from 0-24, with higher scores indicating poorer carer emotional well-being. | Baseline assessment, 3 months post randomization, 6 months post randomization | 
| Change in carer financial well-being at 3 and 6 months | The financial well-being section (items 16-18) of the Carer Wellbeing and Support Scales (CWS) will be used as a secondary outcome measure, measuring the change in carer financial well-being. Each of the items in these sections can be answered using A lot (4) Quite a bit (3) Moderately (2) A little (1) or Not at all (0), with total scores on the scale ranging from 0-12, with higher scores indicating poorer financial well-being. | Baseline assessment, 3 months post randomization, 6 months post randomization | 
| Change in carer physical health at 3 and 6 months | The physical health section (items 19-20) of the Carer Wellbeing and Support Scales (CWS) will be used as a secondary outcome measure, measuring the change in carer physical health. Each of the items in these sections can be answered using A lot (4) Quite a bit (3) Moderately (2) A little (1) or Not at all (0), with total scores on the scale ranging from 0-8, with higher scores indicating poorer carer physical health. | Baseline assessment, 3 months post randomization, 6 months post randomization | 
| Change in carer experience with stigma and discrimination at 3 and 6 months | The stigma and discrimination section (item 27) of the Carer Wellbeing and Support Scales (CWS) will be used as a secondary outcome measure, measuring the change in carer experience with stigma and discrimination. Each of the items in these sections can be answered using A lot (4) Quite a bit (3) Moderately (2) A little (1) or Not at all (0), with total scores on the scale ranging from 0-4, with higher scores indicating poorer carer experience with stigma and discrimination. | Baseline assessment, 3 months post randomization, 6 months post randomization | 
| Change in carer personal safety at 3 and 6 months | The personal safety section (items 28-29) of the Carer Wellbeing and Support Scales (CWS) will be used as a secondary outcome measure, measuring the change in carer personal safety. Each of the items in these sections can be answered using A lot (4) Quite a bit (3) Moderately (2) A little (1) or Not at all (0), with total scores on the scale ranging from 0-8, with higher scores indicating poorer carer personal safety. | Baseline assessment, 3 months post randomization, 6 months post randomization | 
| Change in safety of the person with dementia at 3 and 6 months | The safety of the person with dementia section (items 30-32) of the Carer Wellbeing and Support Scales (CWS) will be used as a secondary outcome measure, measuring the change in the safety of the person with dementia. Each of the items in these sections can be answered using A lot (4) Quite a bit (3) Moderately (2) A little (1) or Not at all (0), with total scores on the scale ranging from 0-12, with higher scores indicating poorer safety of the person with dementia. | Baseline assessment, 3 months post randomization, 6 months post randomization | 
| Change in carer distress at 3 and 6 months | The Distress Questionnaire (DQ-5) scale will be used as a secondary outcome measure, measuring the change in carer distress. The response scale for the DQ5 is Never (1), Rarely (2), Sometimes (3), Often (4) or Always (5), with total scores on the scale ranging from 5-25, with higher scores indicating greater psychological distress. | Baseline assessment, 3 months post randomization, 6 months post randomization | 
| Change in carer self-efficacy at 3 and 6 months | The Family Caregivers' Self-efficacy for Managing Dementia scale will be used as a secondary outcome measure. It includes 10 items and is scored based on a 10-point Likert scale from 1 (not at all certain) to 10 (very certain), with total scores on the scale ranging from 10-100, with lower scores indicating low self-efficacy. | Baseline assessment, 3 months post randomization, 6 months post randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caregiver Burnout, Caregiver Stress, Caregivers, Dementia