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Caregiver BurnoutNCT04944420

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

A study testing Health enSuite Caregivers in people with Caregiver Burnout, run by IWK Health Centre at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Caregiver Burnout
What is being tested?
Health enSuite Caregivers
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteCanada
Study dates
15 May 2026to Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • IWK Health

    Halifax, Nova Scotia, B3K 6R8

Other trials in Canada

About this study

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

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.

Read the 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 wellbeing. 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. We developed Health enSuite Caregivers as a potential solution to this problem.

Being tested
Health enSuite Caregivers
Keywords
Caregiver Burnout, Caregiver Stress, Caregivers, Dementia
Medical subject headings
Caregiver Burden, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health enSuite CaregiversBehavioural

    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.

Study groups in NCT04944420
Study groupRoleWhat they receive
InterventionExperimentalIntervention 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.
Receives: Behavioral: Health enSuite Caregivers
Waitlist ControlNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (3)

  1. Overall carer wellbeing and specific facets of carer welling

    Responses on the CWS will be used to compute several secondary outcomes that may be affected by Health enSuite Caregivers.

    • Total carer wellbeing (sum of all 33 items)
    • Your role as a carer (items 1-5)
    • Relationship with the PWD (items 6-11)
    • Relationships with friends and family (items 12-15)
    • Emotional wellbeing (items 21-26)
    • Financial wellbeing (items 16-18)
    • Physical health (items 19-20)
    • Stigma and discrimination (item 27)
    • Personal safety (item 28-29)
    • Safety of PWD (items 30-32)

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

  2. Self-efficacy

    Caregiver self-efficacy will be measured using the family caregivers' self-efficacy for managing dementia scale (11). It measures the degree of confidence caregivers have about their ability to complete necessary caregiving tasks. It includes 10 items and is scored based on a 10-point Likert scale from 1 ("not at all certain") to 10 ("very certain"). This scale has been widely used in studies of caregivers of people with dementia and has been found to have good internal consistency (11-13).

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

  3. Psychological distress

    The Distress Questionnaire-5 (DQ-5) (18) will be used to assess psychological distress among caregivers. This 5-item measure captures general emotional distress and has demonstrated strong psychometric properties. We hypothesize that participants assigned to the intervention group will report lower levels of psychological distress at both 2- and 5-months post-randomization compared to participants in the control group. Specifically, DQ-5 scores are expected to decrease from baseline to follow-up in the intervention group, reflecting a reduction in emotional distress over time.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2021
  2. Study start15 May 2026
  3. Primary completion15 Mar 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04944420
Sponsor's protocol ID
1026747
Status last verified
Nov 2026
First submitted
14 Jun 2021
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 19585957

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

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

    PubMed 30833490

  • 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.

    PubMed 30967164

  • 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.

    PubMed 31518255

  • 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.

    PubMed 29959111

  • 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.

  • 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.

    PubMed 29538433

  • 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.

    PubMed 12028884

  • 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.

    PubMed 21547745

  • 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.

    PubMed 16449755

  • 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.

  • 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.

    PubMed 23512568

  • 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.

    PubMed 31985249

Questions about this trial

What is this clinical trial studying?

A study testing Health enSuite Caregivers in people with Caregiver Burnout, run by IWK Health Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Carer wellbeing (time frame: Baseline assessment, 2 months post randomization, 5 months post randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04944420, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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