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Caregiver Support Interventions for Dementia Caregiver Stress

N/A

Waitlist Available

Research Sponsored by Case Western Reserve University

Eligibility Criteria Checklist

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

Must have

At least 18 years old

Have a living family member or a recently deceased family member diagnosed with Alzheimer's disease or another dementia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from t1 (baseline) to t2 (6 months) through t3 (one year)

Awards & highlights

Study Summary

This trial will study how giving caregivers different amounts of control over their self-management interventions affects their physical and mental health over time.

Who is the study for?

This trial is for primary caregivers aged 18 or older who are currently providing at least 4 hours of daily care to a family member with Alzheimer's or another dementia, have started caregiving within the last year, visit their cared-for family member in a facility weekly, or manage affairs if the person has recently passed away.Check my eligibility

What is being tested?

The study tests how different levels of caregiver choice in self-management interventions affect their health. Caregivers will be randomly assigned to learn about diversional activities, receive an intervention based on need (SM-need), or choose an intervention they prefer (SM-preference).See study design

What are the potential side effects?

Since this trial involves non-medical interventions like diversional and biofeedback training, side effects may include emotional discomfort or stress due to confronting personal issues during these activities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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A family member of mine has or had Alzheimer's or another form of dementia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from t1 (baseline) to t2 (6 months) through t3 (one year)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from t1 (baseline) to t2 (6 months) through t3 (one year)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from t1 (baseline) to t2 (6 months) through t3 (one 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

Change in Caregiver's Global Health

Change in Caregiver's Health Risk Behavior Scale

Secondary outcome measures

Change in Caregiver's Depressive Cognitions Scales

Change in Caregiver's Heart Rate Variability

Change in Caregiver's Negative Emotions Checklist

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Self-ManagementExperimental Treatment2 Interventions

Group II: Attention Control ConditionActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Resourcefulness Training

2018

N/A

~750

Biofeedback Training

2016

N/A

~420

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Case Western Reserve UniversityLead Sponsor

299 Previous Clinical Trials

259,692 Total Patients Enrolled

7 Trials studying Dementia

20,868 Patients Enrolled for Dementia

Media Library

Resourcefulness Training Clinical Trial Eligibility Overview. Trial Name: NCT04603482 — N/A

Dementia Research Study Groups: Self-Management, Attention Control Condition

Dementia Clinical Trial 2023: Resourcefulness Training Highlights & Side Effects. Trial Name: NCT04603482 — N/A

Resourcefulness Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT04603482 — N/A

Frequently Asked Questions

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

Does this research project have any open slots for enrollment?

"Affirmative. Clinicaltrials.gov reveals that this clinical examination, which was initially published on August 1st 2021, is currently enrolling volunteers. Approximately 300 participants will be recruited from a single site."

Answered by AI

How many participants have been approved to partake in this research?

"Yes, according to clinicaltrials.gov the trial is presently recruiting patients. It was initiallly posted on August 1st 2021 and last updated on December 15th 2021 with a need for 300 participants at one site."

Answered by AI

What are the key aims of this medical study?

"The primary result of this trial will be evaluated between the baseline (T1), 6-month (T2) and 1 year mark (T3). This assessment aims to observe any alterations in Caregiver's Global Health. Additional metrics include Change in Caregiver's Resourcefulness Scale, which is a 28 item survey with scores ranging from 0 - 140; higher values implying greater resourcefulness, Change in Caregiver's Heart Rate Variability measured through non- invasive monitoring relative to average heart rate and scored by standard deviation of milliseconds fluctuation from normal rates; lower values signifying less stress/better resilience towards stressors., as"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dementia Caregiver Career Study

Jaclene A. Zauszniewski 2021. "Dementia Caregiver Career Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04603482.

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