Stress Management Toolkit Prototype User Testing for Dementia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Dementia+2 MoreStress Management Toolkit - CombinationProduct
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Dementia
  • Caregiver Burden
  • Stress

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

6 Primary · 4 Secondary · Reporting Duration: Through study completion, an average of 1 year

Week 2
Frequency of toolkit use
Year 1
Enrollment rate
Frequency of adverse events and injuries
Heart rate
Week 1
Participant perceived benefit with toolkit, as assessed using a toolkit benefit scale
Participant satisfaction with toolkit, as assessed using a toolkit satisfaction scale
Percentage of participant completion of caregiver stress outcome measure, as assessed using the Perceived Stress Scale
Percentage of participant completion of dyadic relationship strain outcome measure, as assessed using the Dyadic Relationship Scale
Dementia
Monitoring, Physiologic

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Stress Management Toolkit Prototype Development
1 of 2
Stress Management Toolkit Prototype User Testing
1 of 2

Active Control

Experimental Treatment

30 Total Participants · 2 Treatment Groups

Primary Treatment: Stress Management Toolkit Prototype User Testing · No Placebo Group · Phase < 1

Stress Management Toolkit Prototype User Testing
CombinationProduct
Experimental Group · 1 Intervention: Stress Management Toolkit · Intervention Types: CombinationProduct
Stress Management Toolkit Prototype DevelopmentNoIntervention Group · 1 Intervention: Stress Management Toolkit Prototype Development · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 1 year

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,414 Previous Clinical Trials
3,484,216 Total Patients Enrolled
217 Trials studying Dementia
900,554 Patients Enrolled for Dementia
Duke UniversityLead Sponsor
2,178 Previous Clinical Trials
3,200,664 Total Patients Enrolled
13 Trials studying Dementia
31,129 Patients Enrolled for Dementia
Susan N Hastings, MDPrincipal InvestigatorDuke University
1 Previous Clinical Trials
1,680 Total Patients Enrolled
Melissa L Harris, PhDPrincipal InvestigatorDuke University School of Nursing

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a diagnosis of dementia of any type.