Clinical trial NCT05465551: Stress Management Toolkit for People Living With Dementia and Their Care Partners
Official title: Development of a Dyadic Stress Management Toolkit for People Living With Dementia and Their Care Partners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Dementia
Stress
Caregiver Burden
Keywords: Nonpharmacological interventions
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-07-20
Enrollment: 44
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion criteria for participants with dementia are:

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

Exclusion criteria for participants with dementia is:

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

Inclusion criteria for care partner participants are:

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

Exclusion criteria for care partner participants is:

• 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

Primary outcomes:
measure: Frequency of toolkit use
timeFrame: End of week 1 of user-testing period
measure: Frequency of toolkit use
timeFrame: End of week 2 of user-testing period
measure: Enrollment rate
timeFrame: Through study completion, an average of 1 year
measure: Withdrawal rate
timeFrame: Through study completion, an average of 1 year
measure: Frequency of adverse events and injuries
timeFrame: Through study completion, an average of 1 year
measure: Participant satisfaction with toolkit, as assessed using a toolkit satisfaction scale
timeFrame: Within 1 week after user-testing period
measure: Participant perceived benefit with toolkit, as assessed using a toolkit benefit scale
timeFrame: Within 1 week after user-testing period
Secondary outcomes:
measure: Percentage of participant completion of neuropsychiatric symptoms of dementia outcome measure, as assessed using the Neuropsychiatric Inventory-Questionnaire
timeFrame: Baseline, pre user-testing period
measure: Percentage of participant completion of neuropsychiatric symptoms of dementia outcome measure, as assessed using the Neuropsychiatric Inventory-Questionnaire
timeFrame: Within 1 week after user-testing period
measure: Percentage of participant completion of caregiver stress outcome measure, as assessed using the Perceived Stress Scale
timeFrame: Baseline, pre user-testing period
measure: Percentage of participant completion of caregiver stress outcome measure, as assessed using the Perceived Stress Scale
timeFrame: Within 1 week after user-testing period
measure: Percentage of participant completion of dyadic relationship strain outcome measure, as assessed using the Dyadic Relationship Scale
timeFrame: Baseline, pre user-testing period
measure: Percentage of participant completion of dyadic relationship strain outcome measure, as assessed using the Dyadic Relationship Scale
timeFrame: Within 1 week after user-testing period
measure: Percentage of participant completion of physiologic stress outcome measure, as assessed through salivary cortisol biospecimens
timeFrame: Baseline, pre user-testing period
measure: Percentage of participant completion of physiologic stress outcome measure, as assessed through salivary cortisol biospecimens
timeFrame: Within 1 week after user-testing period
Other outcomes:
Locations:
city: Durham
country: United States
facility: Caregiver and dementia community support organizations
state: North Carolina
Study officials:
affiliation: Duke University School of Nursing
name: Melissa L Harris, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Susan N Hastings, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.