Stress Management Toolkit for People Living With Dementia and Their Care Partners

NCT ID: NCT05465551

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-20
• Study Completion Date: 2025-01-06

Brief Summary

The purpose of this study is to develop a prototype of a home-based, dyadic tangible toolkit comprised of simple tools to help people living with dementia (PLWD) and their care partners manage stress at home.

A human-centered design approach will be used to develop and user-test a prototype of a dyadic, tangible stress-management toolkit with and for PLWD and their care partners; and to explore the feasibility of collecting several stress-related outcomes. A total of 4 focus groups (n=3-4 dyads/group) will be convened to explore the experiences, perceptions, preferences, and recommendations of dementia-caring dyads regarding stress, stress management, and key components and features of a stress management toolkit. Eligible tools for the toolkit include low burden, high safety tools such as weighted blankets, robotic pets and baby dolls, guided journals, aromatherapy and bright light therapy devices, and massage and acupressure tools. Ten dyads who were not involved in prototype development will then use the toolkit for 2 weeks. Feedback on usability, feasibility, and acceptability will be collected through questionnaires (end of weeks 1 and 2) and 3 focus groups (3-4 dyads/group at end of week 2). We will collect stress-related, participant-reported outcomes (e.g., neuropsychiatric symptoms of dementia, caregiver stress, dyadic relationship strain), and saliva biospecimens from participants with dementia and their care partners at baseline and end of week 2, to explore their utility as endpoints in a future toolkit intervention that uses a single-arm, pre-post study design. Results will yield valuable data to support development and preliminary testing of a stress management toolkit intervention in a future pilot study.

This study involves human subjects and is expected to yield no more than minimal risk. Tools eligible for the toolkit must have demonstrated high degrees of safety in prior research. Major risks for participation include the potential for negative emotional responses to focus group discussions and surveys pertaining to stress, excess time burden to participate in the study, and breach of confidentiality. It is not anticipated, but there is a potential for physical discomfort if tools are not used as directed, which is why the toolkits will include a user guide outlining safety information, which a research team member will review with each participant prior to use.

Conditions

Dementia; Stress; Caregiver Burden

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Stress Management Toolkit Prototype Development

3-4 qualitative focus groups (n=3-4 dyads/group) will be held to explore experiences, perceptions, preferences, and recommendations of dementia-caring dyads regarding stress, stress management, and key components and features of a stress management toolkit. Eligible tools for the toolkit include low burden, high safety tools (e.g., weighted blankets, robotic pets and baby dolls, guided journals, aromatherapy, bright light therapy devices, massage and acupressure tools).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Stress Management Toolkit Prototype User Testing

10 dyads will use the toolkit for 2 weeks in their own homes. Feedback on usability, feasibility, and acceptability will be collected through questionnaires and focus groups. Stress-related, participant-reported outcomes (e.g., neuropsychiatric symptoms of dementia, caregiver stress, dyadic relationship strain), and salivary cortisol biospecimens will be collected at baseline and end of week 2, to explore their utility as endpoints in a future pilot study to examine efficacy.

Group Type: EXPERIMENTAL

Stress Management Toolkit

Intervention Type: COMBINATION_PRODUCT

The toolkit will be a home-based, dyadic tangible toolkit comprised of simple tools to help people living with dementia (PLWD) and their care partners manage stress at home. Potential tools for the toolkit includes low burden, high safety tools such as weighted blankets, robotic pets and baby dolls, guided journals, aromatherapy and bright light therapy devices, and massage and acupressure tools. The tookit will also include user-safety guidelines and directions on how to use each tool. Tools will be included for participants with dementia and care partners.

Interventions

Stress Management Toolkit

The toolkit will be a home-based, dyadic tangible toolkit comprised of simple tools to help people living with dementia (PLWD) and their care partners manage stress at home. Potential tools for the toolkit includes low burden, high safety tools such as weighted blankets, robotic pets and baby dolls, guided journals, aromatherapy and bright light therapy devices, and massage and acupressure tools. The tookit will also include user-safety guidelines and directions on how to use each tool. Tools will be included for participants with dementia and care partners.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• age 60 years and over with a diagnosis of dementia of any type
• able to express self verbally
• English speaking.

• age 21 years and older
• identify as a primary care partner of someone with dementia
• English speaking

Exclusion Criteria

• has a hearing or visual impairment that limits their ability to participate in the screening process or to participate in a focus group.

• has a hearing or visual impairment that limits their ability to participate in the screening process or to participate in a focus group.

Dyadic eligibility criteria include:

• both the PLWD and care partner reside in the same household or personal residence in the community
• dyad has lived together for at least 1 month
• dyad has telephone or internet access
• Dyads will be excluded if they reside in assisted living or other long-term care setting.

Dyads participating in user-testing phase will also be excluded if either member:

• currently receives cytokine-based therapy
• currently receives radiation therapy to the salivary glands or thyroid
• are diagnosed with Cushing or Addison's disease

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melissa L Harris, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University School of Nursing

Susan N Hastings, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Caregiver and dementia community support organizations

Durham, North Carolina, United States

Countries

United States

References

Harris M, Van Houtven C, Hastings S. Development of a Home-Based Stress Management Toolkit for Dementia Caring Dyads: Protocol for a Pilot Intervention Development and Feasibility Study. JMIR Res Protoc. 2022 Dec 14;11(12):e43098. doi: 10.2196/43098.

Reference Type: DERIVED

PMID: 36399169 (View on PubMed)

Other Identifiers

P30AG072958

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00110944

Identifier Type: -

Identifier Source: org_study_id