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Emergency Preparedness for Caregivers of Persons With Dementia: Disaster PrepWise (DPW-Caregiver)

Primary Purpose

Caregiver Resilience and Stress

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Disaster PrepWise-Caregiver
Sponsored by
Sato Ashida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Caregiver Resilience and Stress focused on measuring Alzheimer's disease, Dementia, Caregiver, Disaster preparedness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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 and assisted living 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).

Sites / Locations

  • University of IowaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Disaster PrepWise-Caregiver Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Resilience
Connor-Davidson Resilience Scale (CD-RISC: 25 items). The range is 0 to 100. Higher scores indicate higher resilience.
Caregiver stress
Cohen Perceived Stress Scale (PSS: 14 items). The range is 0 to 40. Higher scores indicate higher perceived stress.

Secondary Outcome Measures

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.
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.
Social Networks
CaREnet: Caregiver Social Network Assessment tool. It is not a scale score. Counts of network members engaging in supportive interactions.

Full Information

First Posted
November 2, 2022
Last Updated
October 20, 2023
Sponsor
Sato Ashida
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT05619263
Brief Title
Emergency Preparedness for Caregivers of Persons With Dementia: Disaster PrepWise
Acronym
DPW-Caregiver
Official Title
Emergency Preparedness and Support for Caregivers of Persons With Dementia: Disaster PrepWise
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 12, 2023 (Actual)
Primary Completion Date
May 30, 2026 (Anticipated)
Study Completion Date
June 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sato Ashida
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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 200 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregiver Resilience and Stress
Keywords
Alzheimer's disease, Dementia, Caregiver, Disaster preparedness

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Disaster PrepWise-Caregiver Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Disaster PrepWise-Caregiver
Intervention Description
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.
Primary Outcome Measure Information:
Title
Resilience
Description
Connor-Davidson Resilience Scale (CD-RISC: 25 items). The range is 0 to 100. Higher scores indicate higher resilience.
Time Frame
Change between baseline and 6-month follow-up
Title
Caregiver stress
Description
Cohen Perceived Stress Scale (PSS: 14 items). The range is 0 to 40. Higher scores indicate higher perceived stress.
Time Frame
Change between baseline and 6-month follow-up
Secondary Outcome Measure Information:
Title
Self-Efficacy
Description
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.
Time Frame
Change between baseline and 6-month follow-up
Title
Caregiver Preparedness
Description
Caregiver Preparedness scale (8 items). The range is 0 to 40. A higher score indicates that the caregiver feels more prepared for caregiving.
Time Frame
Change between baseline and 6-month follow-up
Title
Social Networks
Description
CaREnet: Caregiver Social Network Assessment tool. It is not a scale score. Counts of network members engaging in supportive interactions.
Time Frame
Change between baseline and 6-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 and assisted living 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sato Ashida, PhD
Phone
319-384-1477
Email
sato-ashida@uiowa.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew Peterson
Email
andrew-d-peterson@uiowa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sato Ashida, PhD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Donohoe, MPH
Phone
319-384-1498
Email
maria-donohoe@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Emily Killian, MPH
Email
emily-killian@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Sato Ashida, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Emergency Preparedness for Caregivers of Persons With Dementia: Disaster PrepWise

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