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

NCT05465551 | Completed Early Phase 1

• 2 other identifiers: Pro00110944P30AG072958
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Keywords

Nonpharmacological interventions

Outcome Measures

Primary Outcomes (7)

• Frequency of toolkit use

  Number of days toolkit was used over the last week (range 0-7) will be assessed among participants enrolled in user-testing arm.

  End of week 1 of user-testing period

• Frequency of toolkit use

  Number of days toolkit was used over the last week (range 0-7) will be assessed among participants enrolled in user-testing arm.

  End of week 2 of user-testing period

• Enrollment rate

  Percentage of participant dyads enrolled/dyads screened in user-testing arm.

  Through study completion, an average of 1 year

• Withdrawal rate

  Percentage of dyads that withdraw/dyads enrolled in user-testing arm.

  Through study completion, an average of 1 year

• Frequency of adverse events and injuries

  Number of adverse events and injuries reported in user-testing arm.

  Through study completion, an average of 1 year

• Participant satisfaction with toolkit, as assessed using a toolkit satisfaction scale

  Investigator developed multi-item satisfaction scale will include Likert-scaled items pertaining to satisfaction with design and delivery of the toolkit among participants in the user-testing arm; item ranges 1=not satisfied at all to 5 very satisfied). Scores will be averaged to yield and overall satisfaction score with higher scores indicating a greater degree of satisfaction.

  Within 1 week after user-testing period

• Participant perceived benefit with toolkit, as assessed using a toolkit benefit scale

  Investigator developed multi-item benefit scale will include Likert-scaled items pertaining to perceived benefit from the toolkit among participants in the user-testing arm; item ranges 1=not beneficial at all to 5 very beneficial). Scores will be averaged to yield and overall benefit score with higher scores indicating a greater degree of benefit.

  Within 1 week after user-testing period

Secondary Outcomes (8)

• Percentage of participant completion of neuropsychiatric symptoms of dementia outcome measure, as assessed using the Neuropsychiatric Inventory-Questionnaire

  Baseline, pre user-testing period

• Percentage of participant completion of neuropsychiatric symptoms of dementia outcome measure, as assessed using the Neuropsychiatric Inventory-Questionnaire

  Within 1 week after user-testing period

• Percentage of participant completion of caregiver stress outcome measure, as assessed using the Perceived Stress Scale

  Baseline, pre user-testing period

• Percentage of participant completion of caregiver stress outcome measure, as assessed using the Perceived Stress Scale

  Within 1 week after user-testing period

• Percentage of participant completion of dyadic relationship strain outcome measure, as assessed using the Dyadic Relationship Scale

  Baseline, pre user-testing period

Study Arms (2)

Stress Management Toolkit Prototype Development

NO INTERVENTION

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).

Stress Management Toolkit Prototype User Testing

EXPERIMENTAL

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.

Combination Product: Stress Management Toolkit

Interventions

Stress Management Toolkit 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.

Stress Management Toolkit Prototype User Testing

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• has a hearing or visual impairment that limits their ability to participate in the screening process or to participate in a focus group.
• age 21 years and older
• identify as a primary care partner of someone with dementia
• English speaking
• 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

Sponsors & Collaborators

• Duke University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Caregiver and dementia community support organizations

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

• 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.

  PMID: 36399169 DERIVED

MeSH Terms

Conditions

Dementia; Caregiver Burden

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Melissa L Harris, PhD

  Duke University School of Nursing

  PRINCIPAL INVESTIGATOR

• Susan N Hastings, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 20, 2022
• Study Start: December 20, 2022
• Primary Completion: January 6, 2025
• Study Completion: January 6, 2025
• Last Updated: March 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)