- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04944420
Health enSuite Caregivers: an App-based Treatment for Distressed Caregivers of Persons With Moderate Dementia
Evaluating an App-based Treatment for Distressed Caregivers of Persons With Moderate Dementia: Health enSuite Caregivers Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rekha Dhonde
- Phone Number: 5 1-877-341-8309
- Email: TeamHealthEnSuite@iwk.nshealth.ca
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
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. |
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. |
No Intervention: Waitlist Control
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?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in carer emotional and relationship well-being at 3 and 6 months
Time Frame: Baseline assessment, 3 months post randomization, 6 months post randomization
|
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
Time Frame: Baseline assessment, 3 months post randomization, 6 months post randomization
|
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
Time Frame: Baseline assessment, 3 months post randomization, 6 months post randomization
|
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
Time Frame: Baseline assessment, 3 months post randomization, 6 months post randomization
|
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
Time Frame: Baseline assessment, 3 months post randomization, 6 months post randomization
|
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
Time Frame: Baseline assessment, 3 months post randomization, 6 months post randomization
|
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
Time Frame: Baseline assessment, 3 months post randomization, 6 months post randomization
|
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
Time Frame: Baseline assessment, 3 months post randomization, 6 months post randomization
|
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
Time Frame: Baseline assessment, 3 months post randomization, 6 months post randomization
|
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
Time Frame: Baseline assessment, 3 months post randomization, 6 months post randomization
|
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
Time Frame: Baseline assessment, 3 months post randomization, 6 months post randomization
|
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
Time Frame: Baseline assessment, 3 months post randomization, 6 months post randomization
|
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
Time Frame: Baseline assessment, 3 months post randomization, 6 months post randomization
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Patrick McGrath, IWK Health Centre
Publications and helpful links
General Publications
- Michie S, Richardson M, Johnston M, Abraham C, Francis J, Hardeman W, Eccles MP, Cane J, Wood CE. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med. 2013 Aug;46(1):81-95. doi: 10.1007/s12160-013-9486-6.
- Wozney L, Freitas de Souza LM, Kervin E, Queluz F, McGrath PJ, Keefe J. Commercially Available Mobile Apps for Caregivers of People With Alzheimer Disease or Other Related Dementias: Systematic Search. JMIR Aging. 2018 Dec 7;1(2):e12274. doi: 10.2196/12274.
- Cheng ST, Li KK, Losada A, Zhang F, Au A, Thompson LW, Gallagher-Thompson D. The effectiveness of nonpharmacological interventions for informal dementia caregivers: An updated systematic review and meta-analysis. Psychol Aging. 2020 Feb;35(1):55-77. doi: 10.1037/pag0000401.
- Hango D. Insights on Canadian Society Support received by caregivers in Canada. Stat Canada. 2020;(75).
- 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.
- Canadian Institute for Health Information. Unpaid caregiver challenges and supports. 2018.
- Duggleby W, Ploeg J, McAiney C, Peacock S, Fisher K, Ghosh S, Markle-Reid M, Swindle J, Williams A, Triscott JA, Forbes D, Jovel Ruiz K. Web-Based Intervention for Family Carers of Persons with Dementia and Multiple Chronic Conditions (My Tools 4 Care): Pragmatic Randomized Controlled Trial. J Med Internet Res. 2018 Jun 29;20(6):e10484. doi: 10.2196/10484.
- Quirk A, Smith S, Hamilton S, Lamping D, Lelliott P, Stahl D, et al. Development of the carer well-being and support (CWS) questionnaire. Ment Heal Rev J. 2012 Sep 21;17(3):128-38.
- Fortinsky RH, Kercher K, Burant CJ. Measurement and correlates of family caregiver self-efficacy for managing dementia. Aging Ment Health. 2002 May;6(2):153-60. doi: 10.1080/13607860220126763.
- Gallagher D, Ni Mhaolain A, Crosby L, Ryan D, Lacey L, Coen RF, Walsh C, Coakley D, Walsh JB, Cunningham C, Lawlor BA. Self-efficacy for managing dementia may protect against burden and depression in Alzheimer's caregivers. Aging Ment Health. 2011 Aug;15(6):663-70. doi: 10.1080/13607863.2011.562179. Epub 2011 May 24.
- Spitznagel MB, Tremont G, Davis JD, Foster SM. Psychosocial predictors of dementia caregiver desire to institutionalize: caregiver, care recipient, and family relationship factors. J Geriatr Psychiatry Neurol. 2006 Mar;19(1):16-20. doi: 10.1177/0891988705284713.
- Keefe J, Guberman N, Fancey P, Barylak L, Nahmiash D. Caregivers' Aspirations, Realities, and Expectations: The CARE Tool. J Appl Gerontol. 2008 Jun 11;27(3):286-308.
- Qiu D, Hu M, Yu Y, Tang B, Xiao S. Acceptability of psychosocial interventions for dementia caregivers: a systematic review. BMC Psychiatry. 2019 Jan 14;19(1):23. doi: 10.1186/s12888-018-1976-4.
- Stall N. We should care more about caregivers. CMAJ. 2019 Mar 4;191(9):E245-E246. doi: 10.1503/cmaj.190204. No abstract available.
- Queluz FNFR, Kervin E, Wozney L, Fancey P, McGrath PJ, Keefe J. Understanding the needs of caregivers of persons with dementia: a scoping review. Int Psychogeriatr. 2020 Jan;32(1):35-52. doi: 10.1017/S1041610219000243.
- Dow J, Robinson J, Robalino S, Finch T, McColl E, Robinson L. How best to assess quality of life in informal carers of people with dementia; A systematic review of existing outcome measures. PLoS One. 2018 Mar 14;13(3):e0193398. doi: 10.1371/journal.pone.0193398. eCollection 2018.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1026747
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Caregiver Burnout
-
Wroclaw University of Health and Sport SciencesUniversity of Silesia in Katowice; Jan Dlugosz University in CzestochowaCompleted
-
University Diego PortalesInstituto de Seguridad del Trabajo, ChileRecruitingBurnout | Burnout, Caregiver | Parental BurnoutChile
-
Memorial Sloan Kettering Cancer CenterRecruitingCaregiver Burden | Caregiver Stress Syndrome | Caregiver BurnoutUnited States
-
Indonesia UniversityCompleted
-
Consuelo Lourdes Díaz RodríguezCompleted
-
Hamad Medical CorporationCompletedIntensive Care Unit | Extracorporeal Membrane Oxygenation Complication | Burnout, CaregiverQatar
-
Istanbul Saglik Bilimleri UniversityCompleted
-
Medical University of South CarolinaUniversity of DelawareCompletedBurnout, CaregiverUnited States
-
Washington University School of MedicineCompleted
-
Melanie KeatsNot yet recruiting
Clinical Trials on Health enSuite Caregivers
-
IWK Health CentreNot yet recruiting
-
Universidad de GranadaCompletedEmotional Stress | Performance AnxietySpain
-
ElTyeb, Sara Amir Hassan, M.D.Sudan Medical Specialization Board (SMSB); Elfatih Malik, MDCompletedDevelopmental Disability
-
University of California, San FranciscoCentre de Recherche en Sante de Nouna, Burkina FasoNot yet recruitingAcute Malnutrition in Childhood
-
University of Alabama at BirminghamActive, not recruitingObesity | Utilization, Health CareUnited States
-
Hospices Civils de LyonCompletedChronic Heart Failure | Acute Myocardial InfarctionFrance
-
Hacettepe UniversityCompletedQuality of Life | Dysphagia | Deglutition Disorder | Outcome AssessmentTurkey
-
University of California, San DiegoNational Institute on Minority Health and Health Disparities (NIMHD); National... and other collaboratorsRecruitingChildhood Obesity | Minority HealthUnited States
-
Duke UniversityNational Institute of Nursing Research (NINR)Completed
-
Columbia UniversityNational Institute on Aging (NIA); Department of Health and Human ServicesActive, not recruitingLoneliness | Emotional StressUnited States