Back to resultsHealth enSuite Caregivers: an App-based Treatment for Distressed Caregivers of Persons With Moderate Dementia
Primary Purpose
Caregiver Burnout
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Health enSuite Caregivers
Sponsored by
About this trial
This is an interventional treatment trial for Caregiver Burnout focused on measuring Caregiver Burnout, Caregiver Stress, Caregivers, Dementia
Eligibility Criteria
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:
-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Waitlist Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04944420
Brief Title
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IWK Health Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregiver Burnout
Keywords
Caregiver Burnout, Caregiver Stress, Caregivers, Dementia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
430 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health enSuite Caregivers
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in carer emotional and relationship well-being at 3 and 6 months
Description
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.
Time Frame
Baseline assessment, 3 months post randomization, 6 months post randomization
Secondary Outcome Measure Information:
Title
Change in total carer wellbeing at 3 and 6 months
Description
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.
Time Frame
Baseline assessment, 3 months post randomization, 6 months post randomization
Title
Change in carer concern toward their role as a carer at 3 and 6 months
Description
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.
Time Frame
Baseline assessment, 3 months post randomization, 6 months post randomization
Title
Change in carer relationship with the person with dementia at 3 and 6 months
Description
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.
Time Frame
Baseline assessment, 3 months post randomization, 6 months post randomization
Title
Change in carer relationships with friends and family at 3 and 6 months
Description
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.
Time Frame
Baseline assessment, 3 months post randomization, 6 months post randomization
Title
Change in carer emotional well-being at 3 and 6 months
Description
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.
Time Frame
Baseline assessment, 3 months post randomization, 6 months post randomization
Title
Change in carer financial well-being at 3 and 6 months
Description
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.
Time Frame
Baseline assessment, 3 months post randomization, 6 months post randomization
Title
Change in carer physical health at 3 and 6 months
Description
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.
Time Frame
Baseline assessment, 3 months post randomization, 6 months post randomization
Title
Change in carer experience with stigma and discrimination at 3 and 6 months
Description
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.
Time Frame
Baseline assessment, 3 months post randomization, 6 months post randomization
Title
Change in carer personal safety at 3 and 6 months
Description
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.
Time Frame
Baseline assessment, 3 months post randomization, 6 months post randomization
Title
Change in safety of the person with dementia at 3 and 6 months
Description
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.
Time Frame
Baseline assessment, 3 months post randomization, 6 months post randomization
Title
Change in carer distress at 3 and 6 months
Description
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.
Time Frame
Baseline assessment, 3 months post randomization, 6 months post randomization
Title
Change in carer self-efficacy at 3 and 6 months
Description
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.
Time Frame
Baseline assessment, 3 months post randomization, 6 months post randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rekha Dhonde
Phone
1-877-341-8309
Ext
5
Email
TeamHealthEnSuite@iwk.nshealth.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick McGrath
Organizational Affiliation
IWK Health Centre
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data sets may be retained and stored within the Centre for Research in Family Health as required for future research or program development, if merited. During Consent, participants will be offered the option of allowing their de-identified study data to be re-used by other approved researchers under the conditions that the research projects are approved by an appropriate ethics board and the researchers sign an agreement ensuring confidentiality and restricting data use only to the approved study. A database will be created containing only the data for those participants who agree will be available to researchers who meet these criteria.
IPD Sharing Time Frame
From study closure to five years post publication.
IPD Sharing Access Criteria
During Consent, participants will be offered the option of allowing their de-identified study data to be re-used by other approved researchers under the conditions that the research projects are approved by an appropriate ethics board and the researchers sign an agreement ensuring confidentiality and restricting data use only to the approved study.
Citations:
Citation
Hango D. Insights on Canadian Society Support received by caregivers in Canada. Stat Canada. 2020;(75).
Results Reference
background
PubMed Identifier
19585957
Citation
Brodaty H, Donkin M. Family caregivers of people with dementia. Dialogues Clin Neurosci. 2009;11(2):217-28. doi: 10.31887/DCNS.2009.11.2/hbrodaty.
Results Reference
background
Citation
Canadian Institute for Health Information. Unpaid caregiver challenges and supports. 2018.
Results Reference
background
PubMed Identifier
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Health enSuite Caregivers: an App-based Treatment for Distressed Caregivers of Persons With Moderate Dementia
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