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Stress Management Toolkit for Dementia

Phase < 1

Recruiting

Led By Melissa L Harris, PhD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trialis developing a home-based toolkit of simple tools to help people with dementia & their carers manage stress.

Who is the study for?

This trial is for people aged 60 and over with any type of dementia who can speak English and express themselves verbally. It's also for their care partners. The study aims to help them manage stress at home using a toolkit.

What is being tested?

The trial is testing a stress management toolkit designed specifically for those living with dementia and their caregivers. Participants will use tools like weighted blankets, robotic pets, journals, aromatherapy devices, etc., and provide feedback on the experience.

What are the potential side effects?

Risks are minimal but may include negative emotional reactions during focus groups or surveys about stress, time burden from participating in the study activities, breach of confidentiality, or physical discomfort if tools aren't used properly.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Enrollment rate

Frequency of adverse events and injuries

Frequency of toolkit use

+3 more

Secondary study objectives

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

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Stress Management Toolkit Prototype User TestingExperimental Treatment1 Intervention

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 II: Stress Management Toolkit Prototype DevelopmentActive Control1 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).

Do I qualify?Apply below to find out