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AzTrials

DementiaNCT06635876

Caregivers Preparing for Their Own Health Care Emergency

A study testing Coaching Sessions in people with Dementia and Caregiver Burden, run by University of California, Davis at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The proposed research will develop and test an online Emergency Preparedness Toolkit to help caregivers prepare for their own unexpected health events. Caregivers of persons with dementia often ignore their own health needs as their primary focus is the care of the person with dementia. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Dementia, Caregiver Burden
What is being tested?
Coaching Sessions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteUnited States
Study dates
18 Jul 2025to 3 Aug 2026
Phase
Interventional
Are there results?
None posted in the registry

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

Who may be able to join

  • Must be 55 years of age or older at the time of signing the informed consent
  • Must self-identify as the spouse or partner of the PWD (may be subject to independent verification per PI discretion, e.g., medical record review or a signed doctor's note)
  • Must provide some caregiving to a PWD
  • Must live in the same dwelling as the PWD

Who cannot join

  • Diagnosis of dementia
  • Unable to use or does not have access to a computer
  • Complete deafness or blindness and/or unable to use a telephone
  • Condition that prevents them from performing caregiving duties or providing physical/emotional support to the PWD
  • Unable to follow directions
  • Unable to read or write in English
  • Participation in prior study involving the EPT

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California - Davis

    Sacramento, California, 95817

Other trials in United States

About this study

Official title: Piloting an Online Emergency Preparedness Toolkit for Caregivers Preparing for Their Own Health Care Emergency

The proposed research will develop and test an online Emergency Preparedness Toolkit to help caregivers prepare for their own unexpected health events. Caregivers of persons with dementia often ignore their own health needs as their primary focus is the care of the person with dementia. This can lead to a caregiver delaying their own care and subsequently emergent health events. The Emergency Preparedness Toolkit provides guidance to the caregiver as to how to identify and transfer care to a standby caregiver. The goal is to provide a caregiver with the security and comfort that the person with dementia will be well cared for while they care for their own health needs.

Being tested
Coaching Sessions
Medical subject headings
Dementia, Caregiver Burden

What participants receive

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

  • Coaching SessionsBehavioural

    The coach will use motivational interviewing techniques to:

    1. To assist and guide the caregiver to establish a standby caregiver relationship
    2. To assist and guide the caregiver as to how to use the EPT
Study groups in NCT06635876
Study groupRoleWhat they receive
EPT-CActive comparatorThe EPT-C group will receive two coaching sessions to assist with the completion of the EPT.
Receives: Behavioral: Coaching Sessions
EPT-ANo interventionThe EPT-A group will be responsible for completing the EPT alone, without coaching sessions.

What is being measured

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

  1. Completion of the EPT six weeks from the baseline visit

    This will be measured using de-identified data from the EPT system.

    Measured: Six weeks

Secondary outcomes (5)

  1. Identification and engagement of a standby caregiver six weeks from the baseline visit

    This will be measured using de-identified data from the EPT system.

    Measured: Six weeks

  2. Change in caregiver preparedness from baseline to Month 3

    This will be measured using the Caregiver Preparedness Scale (CPS). Responses are rated from 0 to 4. The higher the score, the more prepared the caregiver feels for caregiver; the lower the score, the less prepared the caregiver feels.

    Measured: Three months

  3. Change in caregiver confidence from baseline to Month 3

    This will be measured using a Likert scale of caregiver confidence from "completely confident" to "not at all confident". Responses will be grouped into two categories: confident (completely confident, fairly confident, or somewhat confident) or not confident (slightly confident or not at all confident).

    Measured: Three months

  4. Change in caregiving self-efficacy from baseline to Month 3

    This will be measured using the Revised Scale for Caregiver Self-Efficacy (RSCSE). Responses are rated from 0 to 100. The higher the score, the more self-efficacious the caregiver feels about caregiving; the lower the score, the less self-efficacious the caregiver feels.

    Measured: Three months

  5. Qualitative data and theme identification from participant experience surveys and EPT-C coaching session recordings

    This will be measured using a qualitative descriptive approach and theme identification, based on participant experience surveys and EPT-C coaching session recordings.

    Measured: Three months

Timeline

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

  1. First posted10 Oct 2024
  2. Study start18 Jul 2025
  3. Primary completion11 Jun 2026
  4. Study completion3 Aug 2026

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06635876
Sponsor's protocol ID
2180909
Other IDs
1R21AG089840-01, 5R21AG089840-02
Status last verified
Aug 2026
First submitted
8 Oct 2024
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

  • Ornstein KA, Wolff JL, Bollens-Lund E, Rahman OK, Kelley AS. Spousal Caregivers Are Caregiving Alone In The Last Years Of Life. Health Aff (Millwood). 2019 Jun;38(6):964-972. doi: 10.1377/hlthaff.2019.00087.

    PubMed 31158025

  • Rykkje L, Tranvåg O. Caring for one's wife with dementia-at home: older husbands' experiences with managing challenges of everyday life. Sage Open. 2019;9(1):215824401983445. doi:10.1177/2158244019834453

  • Perkins M, Howard VJ, Wadley VG, Crowe M, Safford MM, Haley WE, Howard G, Roth DL. Caregiving strain and all-cause mortality: evidence from the REGARDS study. J Gerontol B Psychol Sci Soc Sci. 2013 Jul;68(4):504-12. doi: 10.1093/geronb/gbs084. Epub 2012 Oct 2.

    PubMed 23033358

  • Tarlow BJ, Wisniewski SR, Belle SH, Rubert M, Ory MG, Gallagher-Thompson D. Positive aspects of caregiving: Contributions of the REACH project to the development of new measures for Alzheimer's caregiving. Res Aging. 2004;26(4):429-453. doi:10.1177/0164027504264493

  • Pinquart M, Sorensen S. Correlates of physical health of informal caregivers: a meta-analysis. J Gerontol B Psychol Sci Soc Sci. 2007 Mar;62(2):P126-37. doi: 10.1093/geronb/62.2.p126.

    PubMed 17379673

  • Adelman RD, Tmanova LL, Delgado D, Dion S, Lachs MS. Caregiver burden: a clinical review. JAMA. 2014 Mar 12;311(10):1052-60. doi: 10.1001/jama.2014.304.

    PubMed 24618967

  • Boxer RS, Daddato AE, Jessen A, Portz JD, Shetterly S. Hospitalizations of Caregivers Increases Risk of Hospitalization for Patients Living with Dementia. J Gen Intern Med. 2023 Feb;38(2):502-507. doi: 10.1007/s11606-022-07902-w. Epub 2022 Nov 14. No abstract available.

    PubMed 36376629

  • Whitlatch CJ, Orsulic-Jeras S. Meeting the Informational, Educational, and Psychosocial Support Needs of Persons Living With Dementia and Their Family Caregivers. Gerontologist. 2018 Jan 18;58(suppl_1):S58-S73. doi: 10.1093/geront/gnx162.

    PubMed 29361068

  • Pearce J, Forsyth W, Boyd R, Jackson GA. Empowering people with dementia: Rutherglen and Cambuslang Values History Project. Dementia. 2012;11(5):695-698. doi:10.1177/1471301211431364

  • Mittelman MS, Haley WE, Clay OJ, Roth DL. Improving caregiver well-being delays nursing home placement of patients with Alzheimer disease. Neurology. 2006 Nov 14;67(9):1592-9. doi: 10.1212/01.wnl.0000242727.81172.91.

    PubMed 17101889

  • Yaffe K, Fox P, Newcomer R, Sands L, Lindquist K, Dane K, Covinsky KE. Patient and caregiver characteristics and nursing home placement in patients with dementia. JAMA. 2002 Apr 24;287(16):2090-7. doi: 10.1001/jama.287.16.2090.

    PubMed 11966383

  • Young HM, Bell JF, Whitney RL, Ridberg RA, Reed SC, Vitaliano PP. Social Determinants of Health: Underreported Heterogeneity in Systematic Reviews of Caregiver Interventions. Gerontologist. 2020 Feb 14;60(Suppl 1):S14-S28. doi: 10.1093/geront/gnz148.

    PubMed 32057083

  • Wawrziczny E, Berna G, Ducharme F, Kergoat MJ, Pasquier F, Antoine P. Modeling the Distress of Spousal Caregivers of People with Dementia. J Alzheimers Dis. 2017;55(2):703-716. doi: 10.3233/JAD-160558.

    PubMed 27716667

  • Turner RL, Reese-Melancon C, Harrington EE, Andreo M. Caregiving During the COVID-19 Pandemic: Factors Associated With Feelings of Caregiver Preparedness. J Appl Gerontol. 2023 Oct;42(10):2089-2099. doi: 10.1177/07334648231182242. Epub 2023 Jul 3.

    PubMed 37395127

Questions about this trial

What is this clinical trial studying?

A study testing Coaching Sessions in people with Dementia and Caregiver Burden, run by University of California, Davis at 1 site in United States.

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

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. 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: finished, as of the sponsor's last update on 17 Aug 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 United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Completion of the EPT six weeks from the baseline visit (time frame: Six weeks). 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 NCT06635876, which also lists 39 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 17 Aug 2026.

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