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

NCT04944420 | Not Yet Recruiting

• 1 other identifier: 1026747
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Caregiver Burnout

Keywords

Caregiver Burnout; Caregiver Stress; Caregivers; Dementia

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline assessment, 2 months post randomization, 5 months post randomization

Secondary Outcomes (3)

• Overall carer wellbeing and specific facets of carer welling

  Baseline assessment, 2 months post randomization, 5 months post randomization

• Self-efficacy

  Baseline assessment, 2 months post randomization, 5 months post randomization

• Psychological distress

  Baseline assessment, 2 months post randomization, 5 months post randomization

Study Arms (2)

Intervention

EXPERIMENTAL

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

Waitlist Control

NO INTERVENTION

Participants in the control group will be waitlisted 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.

Interventions

Health enSuite Caregivers BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

To be eligible for this trial, participants will have to satisfy the following criteria: 1. The participant is 18 years or older. 2. The participant has regular access to an internet connected device (e.g., smartphone, tablet, or computer). 3. The participant is a caregiver of a person with moderate dementia. 4. The participant provides a least one hour of care per week. 5. The participant is experiencing distress associated with caregiving (score DQ5 \>= 11). Rational: Health enSuite Caregivers program being tested in this trial requires the use of an internet connected device. Health enSuite Caregivers can be downloaded as a mobile application for use on a smartphone or tablet, or it can be accessed through the web browser on an electronic device with an internet connection. People who do not have regular access to an internet connected device are unlikely to benefit from Health enSuite Caregivers, and therefore they will be excluded. Health enSuite Caregivers is designed to help primary caregivers of persons with moderate dementia. Therefore, the eligibility screening questionnaire includes items to assess dementia severity. To ensure that the participants has ongoing caregiving duties, they must self-report providing at least one hour of care per week. There is no clear consensus on the number of hours of care that all primary caregivers provide. Reports from the Canadian Institute for Health Informatics estimate that on average informal caregivers of persons with dementia provide 26 hours of care per week (3). One hour per week was selected as a minimum threshold to exclude people with very limited caregiving responsibilities. Health enSuite Caregivers is intended to help caregivers who are experiencing some degree of distress. Participants must also score above the cut-off score (\>=11) for distress on the DQ-5 (18), a population distress screening measure.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• IWK Health Centre: lead

Related Publications (17)

• Hango D. Insights on Canadian Society Support received by caregivers in Canada. Stat Canada. 2020;(75).

  BACKGROUND

• 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.

  PMID: 19585957 BACKGROUND

• Canadian Institute for Health Information. Unpaid caregiver challenges and supports. 2018.

  BACKGROUND

• Stall N. We should care more about caregivers. CMAJ. 2019 Mar 4;191(9):E245-E246. doi: 10.1503/cmaj.190204. No abstract available.

  PMID: 30833490 BACKGROUND

• 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.

  PMID: 30967164 BACKGROUND

• 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.

  PMID: 31518255 BACKGROUND

• 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.

  PMID: 29959111 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 29538433 BACKGROUND

• 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.

  PMID: 12028884 BACKGROUND

• 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.

  PMID: 21547745 BACKGROUND

• 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.

  PMID: 16449755 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 23512568 BACKGROUND

• 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.

  PMID: 31985249 BACKGROUND

• 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.

  PMID: 30642300 BACKGROUND

• Batterham PJ, Werner-Seidler A, O'Dea B, Calear AL, Maston K, Mackinnon A, Christensen H. Psychometric properties of the Distress Questionnaire-5 (DQ5) for measuring psychological distress in adolescents. J Psychiatr Res. 2024 Jan;169:58-63. doi: 10.1016/j.jpsychires.2023.11.004. Epub 2023 Nov 18.

  PMID: 38000185 BACKGROUND

MeSH Terms

Conditions

Caregiver Burden; Dementia

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Patrick McGrath

  IWK Health Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rekha Dhonde

CONTACT

1-877-341-8309; TeamHealthEnSuite@iwk.nshealth.ca

Maryam Akbari

CONTACT

Maryam.Akbari@iwk.nshealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This project consists of a pragmatic randomized controlled trial (RCT). The Consolidated Standards of Reporting Trials (CONSORT) recommendations (http://www.consort-statement.org/) will be used to guide the methodology. Participants will be randomly allocated in a 1:1 ratio to either the intervention group or a waitlist control group. Participants in both groups will complete self-assessments, including key outcome measures, at baseline, and 2-, and 5-months post-randomization. Participants in the intervention group will receive the full Health enSuite Caregivers program described below immediately after being randomized to this group. Participants in the control group will be waitlisted 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 Record Dates

• First Submitted: June 14, 2021
• First Posted: June 29, 2021
• Study Start: February 15, 2026
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: January 27, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: From study closure to five years post publication.
• 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.