- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03550131
Innovations in Dementia Empowerment and Action (IDEA)
Aging With Pride: Innovations in Dementia Empowerment and Action
Study Overview
Status
Conditions
Detailed Description
We will address the following aims:
Aim 1. Test the translation and enhancement of intervention designed to increase physical activities of older adult care receivers (CRs) with AD/RD and their CGs. Aim 2. Evaluate the short- and long-term effect of the standard and personalized intervention on primary (physical activity and functioning; perceived stress for CGs; independence/residential status (institutionalization) for CRs) and secondary outcomes (HRQOL; depressive symptomatology; behavioral disturbances for CRs). Aim 3. Test the moderating roles of CR-CG characteristics, including type of CR-CG relationship, sex, and severity of CR AD/RD, on the treatment effect of the standard and personalized intervention.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Washington
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Seattle, Washington, United States, 98105
- University of Washington
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion criteria for care receiver
- Age at enrollment is 50 years of age or older
- Have dementia, (e.g., Alzheimer's disease, MCI, Vascular dementia, Parkinson's disease, Lewy Body dementia) or memory loss significant enough to affect daily activities
- Living in the community, not in a care facility.
- Living in the U.S.
- Either the care receiver or care giver must self-identify as LGBT (or sexual or gender non-binary or same sex sexual behavior)
Inclusion criteria for care giver
- Provide care to the care recipient with dementia.
- Willing to spend 30 minutes daily for study activities (or coordinate for someone to.)
- Unpaid
- Live in the community, not in a care facility
- Living in the U.S.
Neither care receiver nor caregiver:
- Has known terminal illness (with death anticipated within the next 12 months)
- Was hospitalized for a psychiatric disorder in the 12 months prior to baseline
- Is currently suicidal or having major hallucinations or delusions
- Plans to move to long term care setting within 6 months of enrollment.
- Has any physical limitations/chronic conditions preventing participation in an exercise program.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard intervention
Reducing Disabilities in Alzheimer's Disease (RDAD): 9 60-minute virtual sessions for 6 weeks and 4 15-minute follow-up phone sessions for 4 months |
The RDAD intervention includes behavioral management training for caregiver and activities and exercise training for caregiver and care receiver.
Other Names:
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Experimental: Personalized intervention
Innovations in Dementia Empowerment and Action (IDEA): 9 60-minute virtual sessions for 6 weeks and 4 15-minute follow-up phone sessions for 4 months |
The IDEA intervention has the same exposure to treatment as the RDAD intervention.
The behavioral component of the treatment manual is adapted to incorporate 3 risk factors that are empirically known to affect midlife and older LGBT populations.These include: 1) identity management; 2) stigma-related adverse/traumatic life events; and 3) lack of social support.
All other aspects of the treatment are preserved.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Perceived Stress (PSS) of Caregiver
Time Frame: Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months
|
14-item self-report measure designed to measure nonspecific, appraised stress during the past month
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Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months
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Change in Physical Activity of Care Recipient
Time Frame: Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months
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Days exercise >= 30 min in the past week
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Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months
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Change in Physical Activity of Caregiver
Time Frame: Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months
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Days exercise >= 30 min in the past week
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Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months
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Change in Physical Functioning of Care Recipient
Time Frame: Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months
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Medical outcomes study short form (MOS SF-36)
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Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months
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Change in Physical Functioning of Caregiver
Time Frame: Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months
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Medical outcomes study short form (MOS SF-36)
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Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Quality of Life (QOL-AD) of Care Recipient
Time Frame: Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months
|
QOL-AD measure
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Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months
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Change in Rate of Care-Recipient Behavioral Disturbances
Time Frame: Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months
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Revised Memory and Behavior Problem Checklist (RMBPC) assess presence and frequency of memory, depressive, disruptive behavior and caregiver response
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Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months
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Change in Depressive Symptomatology of Caregiver
Time Frame: Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months
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CESD-10
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Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Karen Fredriksen-Goldsen, PhD, University of Washington
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Neurocognitive Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Tauopathies
- Cognition Disorders
- Intracranial Arterial Diseases
- Intracranial Arteriosclerosis
- Leukoencephalopathies
- Parkinson Disease
- Dementia
- Alzheimer Disease
- Cognitive Dysfunction
- Lewy Body Disease
- Dementia, Vascular
Other Study ID Numbers
- STUDY00003076
- 1R01AG055488-01A1 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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