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Stress Management Toolkit for Dementia

Q: Is recruitment still open for this research endeavor?

Affirmative. According to clinicaltrials.gov, this trial has been open since February 1st 2023 and is actively seeking new patients. 30 people are needed from one medical site for the study's completion.

Q: How many individuals are enrolled in this clinical examination?

Affirmative, the information available on clinicaltrials.gov illustrates that this study is still inviting subjects to participate. Initially published on February 1st 2023 and edited as recently as November 10th 2022, it currently seeks to recruit 30 patients from a single site.

Q: What are the fundamental goals of this trial?

The primary purpose of this year-long study is to assess the frequency of toolkit usage. Secondary objectives include calculating the completion rate for perceived stress and dyadic relationship measures, as well as salivary cortisol biospecimens collected from participants in the user-testing arm. The Perceived Stress Scale involves 10 questions answered on a 5 point scale with higher scores indicating heightened levels of distress, while Dyadic Relationship Scales involve versions tailored both towards care recipients (10 items) and partners (11 items). Salivary samples must be collected five times post user-testing by individuals at home using sample kits sent through mail.

Phase < 1

Recruiting

Led By Susan N Hastings, MD

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Enrollment rate

Frequency of adverse events and injuries

Frequency of toolkit use

+3 more

Secondary outcome measures

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

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

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Who is running the clinical trial?

Duke UniversityLead Sponsor

2,363 Previous Clinical Trials

3,420,456 Total Patients Enrolled

18 Trials studying Dementia

41,033 Patients Enrolled for Dementia

National Institute on Aging (NIA)NIH

1,675 Previous Clinical Trials

28,020,895 Total Patients Enrolled

268 Trials studying Dementia

23,627,576 Patients Enrolled for Dementia

Susan N Hastings, MDPrincipal InvestigatorDuke University

1 Previous Clinical Trials

1,815 Total Patients Enrolled

Media Library

Stress Management Toolkit Clinical Trial Eligibility Overview. Trial Name: NCT05465551 — Phase < 1

Dementia Research Study Groups: Stress Management Toolkit Prototype Development, Stress Management Toolkit Prototype User Testing

Dementia Clinical Trial 2023: Stress Management Toolkit Highlights & Side Effects. Trial Name: NCT05465551 — Phase < 1

Stress Management Toolkit 2023 Treatment Timeline for Medical Study. Trial Name: NCT05465551 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment still open for this research endeavor?

"Affirmative. According to clinicaltrials.gov, this trial has been open since February 1st 2023 and is actively seeking new patients. 30 people are needed from one medical site for the study's completion."

Answered by AI

How many individuals are enrolled in this clinical examination?

"Affirmative, the information available on clinicaltrials.gov illustrates that this study is still inviting subjects to participate. Initially published on February 1st 2023 and edited as recently as November 10th 2022, it currently seeks to recruit 30 patients from a single site."

Answered by AI

What are the fundamental goals of this trial?

"The primary purpose of this year-long study is to assess the frequency of toolkit usage. Secondary objectives include calculating the completion rate for perceived stress and dyadic relationship measures, as well as salivary cortisol biospecimens collected from participants in the user-testing arm. The Perceived Stress Scale involves 10 questions answered on a 5 point scale with higher scores indicating heightened levels of distress, while Dyadic Relationship Scales involve versions tailored both towards care recipients (10 items) and partners (11 items). Salivary samples must be collected five times post user-testing by individuals at home using sample kits sent through mail."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Stress Management Toolkit for People Living With Dementia and Their Care Partners". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05465551.

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