Caregiver Resilience and StressDPW-CaregiverNCT05619263
Emergency Preparedness for Caregivers of Persons With Dementia: Disaster PrepWise
A study testing Disaster PrepWise-Caregiver in people with Caregiver Resilience and Stress, run by Sato Ashida at 1 site in United States.
Trial summary
Individuals with dementia and their families are especially vulnerable during a disaster as it limits caregivers' ability to continue with care due to disaster related stress and reduced access to resources and support. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregiver Resilience and Stress
- What is being tested?
- Disaster PrepWise-Caregiver
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2023to 30 Jun 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
Who may be able to join
- English speaking adults (18 years and older)
- Family members (e.g., biological and non-biological relatives, friends) of individuals diagnosed with ADRD regardless of whether they live with the individual or not. Individuals will not be excluded based on race/ethnicity, gender, or sexual orientation.
Who cannot join
- Families of those diagnosed as predementia or mild cognitive impairment are excluded from the parent study due to differing care needs.
- DPW addresses the needs of community-dwelling individuals, thus, caregivers of those living in nursing homes facilities will be excluded.
- Caregivers with physical or cognitive conditions that prevent them from consenting or providing responses to questions will be excluded following evaluation ("Evaluation to Sign an Informed Consent Document for Research," UI IRB).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Emergency Preparedness and Support for Caregivers of Persons With Dementia: Disaster PrepWise
Individuals with dementia and their families are especially vulnerable during a disaster as it limits caregivers' ability to continue with care due to disaster related stress and reduced access to resources and support. The COVID-19 pandemic showed the extreme vulnerability of persons with dementia (PWD) and their caregivers as they struggled to access support and resources due to the threat of COVID-19 infection; such impact was exacerbated in rural areas where caregivers are geographically isolated and disaster management resources are scarce. With the number of federally declared disasters increasing dramatically over the past 50 years, active public health efforts are needed to support caregivers in developing emergency caregiving plans usable in disasters such as pandemics and extreme weather emergencies. The long-term goal of this project is to enhance emergency preparedness and support networks of caregivers of PWD to increase their resilience and minimize distress by implementing an intervention program, Disaster PrepWise (DPW). In the DPW program, a trained Medical Reserve Corp (MRC) volunteer will provide step-by-step guidance to caregivers to jointly develop emergency preparedness plans and personal support networks. The objectives of this proposed study are to 1) test the impact of DPW on caregiver outcomes (i.e., resilience, stress) and perceptions that may mediate the association between DPW and outcomes (caregiver self-efficacy, preparedness, social support); and 2) evaluate implementation strategies in a real-world setting to optimize future dissemination. We will conduct a randomized control trial of 250 caregivers of persons with dementia involving two arms: DPW intervention group and an information-only control group (print information on disaster preparedness). Assessments will occur before randomization (baseline), and 3 and 6 months after the baseline. This study is innovative in its use of a highly personalized disaster preparedness program with built-in assistance to support caregivers; the support will be provided through an existing national-level public health infrastructure (MRC) that has a great potential to reach older adults and caregivers in rural areas. The knowledge and data obtained through this study will lay the foundation for a future larger-scale multi-state pragmatic trial to assess dissemination potentials.
- Conditions
- Caregiver Resilience and Stress
- Being tested
- Disaster PrepWise-Caregiver
- Keywords
- Alzheimer's disease, Dementia, Caregiver, Disaster preparedness
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disaster PrepWise-CaregiverBehavioural
The Disaster PrepWise (DPW) intervention consists of five interactive modules and two supplemental sections (special topics and resources on various types of disasters). The five modules are: (1) Complete a Personal \& Household Assessment, (2) Develop a Personal Emergency Network, (3) Develop Emergency Information \& Gather Important Documents, (4) Keep a 3-5 Day Supply of Medications \& Medical Supplies, and (5) Build an Emergency Supply Kit. Through an initial visit (IV1) and a follow-up phone conversation 4 weeks later (IV2), the interventionist will develop a personalized disaster management plan and provide it to the participant for sharing with family and friends. Eight weeks after the initial session, the interventionist will make a final follow-up call (IV3) to provide any additional assistance caregivers may need.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Caregivers who consent to participate, complete a baseline survey, and are assigned to the control arm will receive a four-page handout on Emergency Preparedness published by the Alzheimer's Association that provides tips on preparing for disasters and what to do during and after a disaster. Control participants will complete follow-up surveys at 3 and 6 months, similar to intervention participants. |
| Disaster PrepWise-Caregiver Intervention | Experimental | Caregivers who consent to participate, complete a baseline survey, and are assigned to the intervention arm will receive a Disaster PrepWise-Caregiver program from a trained interventionist and receive a completed household emergency management plan. Control participants will complete follow-up surveys at 3 and 6 months, similar to intervention participants. Receives: Behavioral: Disaster PrepWise-Caregiver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resilience
Connor-Davidson Resilience Scale (CD-RISC: 25 items). The range is 0 to 100. Higher scores indicate higher resilience.
Measured: Change between baseline and 6-month follow-up
Caregiver stress
Cohen Perceived Stress Scale (PSS: 14 items). The range is 0 to 40. Higher scores indicate higher perceived stress.
Measured: Change between baseline and 6-month follow-up
Secondary outcomes (3)
Self-Efficacy
Caregiver Self-Efficacy (SE to manage care, 5 items; SE to use services, 4 items). The range is 0-10. A higher score indicates a higher amount of self-efficacy.
Measured: Change between baseline and 6-month follow-up
Caregiver Preparedness
Caregiver Preparedness scale (8 items). The range is 0 to 40. A higher score indicates that the caregiver feels more prepared for caregiving.
Measured: Change between baseline and 6-month follow-up
Social Networks
CaREnet: Caregiver Social Network Assessment tool. It is not a scale score. Counts of network members engaging in supportive interactions.
Measured: Change between baseline and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start12 Jul 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver Resilience and StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sato Ashida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor-investigator, Sato Ashida, University of Iowa
- Investigators
- Sato Ashida, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05619263
- Sponsor's protocol ID
- 202201195
- Other IDs
- 1R01AG077436
- Acronym
- DPW-Caregiver
- Status last verified
- Oct 2026
- First submitted
- 2 Nov 2022
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Preparedness and Support for Caregivers of Persons With Dementia: Disaster PrepWise
- ClinicalTrials.gov ID
- NCT05619263
- Acronym / sponsor ID
- DPW-Caregiver / 202201195
- Conditions
- Caregiver Resilience and Stress
- Keywords
- Alzheimer's disease, Dementia, Caregiver, Disaster preparedness
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Sato AshidaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 16 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Individuals with dementia and their families are especially vulnerable during a disaster as it limits caregivers' ability to continue with care due to disaster related stress and reduced access to resources and support. The COVID-19 pandemic showed the extreme vulnerability of persons with dementia (PWD) and their caregivers as they struggled to access support and resources due to the threat of COVID-19 infection; such impact was exacerbated in rural areas where caregivers are geographically isolated and disaster management resources are scarce. With the number of federally declared disasters increasing dramatically over the past 50 years, active public health efforts are needed to support caregivers in developing emergency caregiving plans usable in disasters such as pandemics and extreme weather emergencies. The long-term goal of this project is to enhance emergency preparedness and support networks of caregivers of PWD to increase their resilience and minimize distress by implementing an intervention program, Disaster PrepWise (DPW). In the DPW program, a trained Medical Reserve Corp (MRC) volunteer will provide step-by-step guidance to caregivers to jointly develop emergency preparedness plans and personal support networks. The objectives of this proposed study are to 1) test the impact of DPW on caregiver outcomes (i.e., resilience, stress) and perceptions that may mediate the association between DPW and outcomes (caregiver self-efficacy, preparedness, social support); and 2) evaluate implementation strategies in a real-world setting to optimize future dissemination. We will conduct a randomized control trial of 250 caregivers of persons with dementia involving two arms: DPW intervention group and an information-only control group (print information on disaster preparedness). Assessments will occur before randomization (baseline), and 3 and 6 months after the baseline. This study is innovative in its use of a highly personalized disaster preparedness program with built-in assistance to support caregivers; the support will be provided through an existing national-level public health infrastructure (MRC) that has a great potential to reach older adults and caregivers in rural areas. The knowledge and data obtained through this study will lay the foundation for a future larger-scale multi-state pragmatic trial to assess dissemination potentials.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Caregivers who consent to participate, complete a baseline survey, and are assigned to the control arm will receive a four-page handout on Emergency Preparedness published by the Alzheimer's Association that provides tips on preparing for disasters and what to do during and after a disaster. Control participants will complete follow-up surveys at 3 and 6 months, similar to intervention participants. |
| Disaster PrepWise-Caregiver Intervention | Experimental | Behavioral: Disaster PrepWise-CaregiverCaregivers who consent to participate, complete a baseline survey, and are assigned to the intervention arm will receive a Disaster PrepWise-Caregiver program from a trained interventionist and receive a completed household emergency management plan. Control participants will complete follow-up surveys at 3 and 6 months, similar to intervention participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- English speaking adults (18 years and older)
- Family members (e.g., biological and non-biological relatives, friends) of individuals diagnosed with ADRD regardless of whether they live with the individual or not. Individuals will not be excluded based on race/ethnicity, gender, or sexual orientation.
Key exclusion criteria (3 listed)
- Families of those diagnosed as predementia or mild cognitive impairment are excluded from the parent study due to differing care needs.
- DPW addresses the needs of community-dwelling individuals, thus, caregivers of those living in nursing homes facilities will be excluded.
- Caregivers with physical or cognitive conditions that prevent them from consenting or providing responses to questions will be excluded following evaluation ("Evaluation to Sign an Informed Consent Document for Research," UI IRB).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Disaster PrepWise-CaregiverThe Disaster PrepWise (DPW) intervention consists of five interactive modules and two supplemental sections (special topics and resources on various types of disasters). The five modules are: (1) Complete a Personal \& Household Assessment, (2) Develop a Personal Emergency Network, (3) Develop Emergency Information \& Gather Important Documents, (4) Keep a 3-5 Day Supply of Medications \& Medical Supplies, and (5) Build an Emergency Supply Kit. Through an initial visit (IV1) and a follow-up phone conversation 4 weeks later (IV2), the interventionist will develop a personalized disaster management plan and provide it to the participant for sharing with family and friends. Eight weeks after the initial session, the interventionist will make a final follow-up call (IV3) to provide any additional assistance caregivers may need. | Behavioural | Disaster PrepWise-Caregiver Intervention |
Primary outcome
Resilience
Time frame: Change between baseline and 6-month follow-up
Connor-Davidson Resilience Scale (CD-RISC: 25 items). The range is 0 to 100. Higher scores indicate higher resilience.
Caregiver stress
Time frame: Change between baseline and 6-month follow-up
Cohen Perceived Stress Scale (PSS: 14 items). The range is 0 to 40. Higher scores indicate higher perceived stress.
3 secondary outcomes
Self-Efficacy
Time frame: Change between baseline and 6-month follow-up
Caregiver Preparedness
Time frame: Change between baseline and 6-month follow-up
Social Networks
Time frame: Change between baseline and 6-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sato Ashida, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Disaster PrepWise-Caregiver in people with Caregiver Resilience and Stress, run by Sato Ashida 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 2 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 27 Oct 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?
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?
Resilience (time frame: Change between baseline and 6-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2026.