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Innovations in Dementia Empowerment and Action (IDEA)

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ClinicalTrials.gov Identifier: NCT03550131
Recruitment Status : Active, not recruiting
First Posted : June 8, 2018
Last Update Posted : February 14, 2023
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Karen Fredriksen Goldsen, University of Washington

Study Description
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Brief Summary:
The lack of efficacious research-based interventions for such vulnerable older adults with Alzheimer's disease and related dementias (AD/RD) and their caregivers (CGs) is a significant public health problem. Caregiving of sexual/gender minority older adults with AD/RD is of concern due to social stigma, marginalization, and isolation, which may be barriers to sustaining caregiving. It is necessary and timely to translate evidence-based culturally adaptable interventions for this underserved and stigmatized population. Reducing Disability in Alzheimer's Disease (RDAD) has been evaluated in a randomized controlled trial and has shown to successfully train community-dwelling CR (care receiver)-CG dyads to increase the physical activity and functioning of individuals with AD/RD and their CGs and to teach CGs techniques for managing behavioral symptoms of CRs. RDAD consequently decreases stress of CGs, delays institutionalization of CRs, and increases health related quality of life (HRQOL) of CRs and CGs. Thus, this study will evaluate the effect of the standard RDAD among lesbian, gay, bisexual, and transgender (LGBT) CRs with AD/RD and their CGs, and this study will test a personalized intervention tailored to better respond to distinct risks experienced by CGs and LGBT CRs with AD/RD, addressing unique sexual/gender minority CG risk factors (e.g., identity management, stigma-related adverse or traumatic life events, and lack of social support).

Condition or disease Intervention/treatment Phase
Alzheimer Disease Dementia Mild Cognitive Impairment Parkinson Disease Dementia Lewy Body Dementia Vascular Dementia Behavioral: Innovations in Dementia Empowerment and Action (IDEA) Behavioral: Reducing Disabilities in Alzheimer's Disease (RDAD) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 322 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study will utilize a 2-group randomized controlled trial design including 2 pre-intervention and 4 post-intervention assessments. The comparator group (standard intervention) will have 112 caregiver-care receiver dyads, and the experimental group (personalized intervention) will have 113 caregiver-care receiver dyads.
Masking: Single (Participant)
Masking Description: Participants receiving intervention will not be informed whether it is the standard or personalized treatment.
Primary Purpose: Treatment
Official Title: Aging With Pride: Innovations in Dementia Empowerment and Action
Actual Study Start Date : December 5, 2018
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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

 Behavioral: Reducing Disabilities in Alzheimer's Disease (RDAD)
The RDAD intervention includes behavioral management training for caregiver and activities and exercise training for caregiver and care receiver.
Other Name: Standard RDAD
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

 Behavioral: Innovations in Dementia Empowerment and Action (IDEA)
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 Name: Personalized RDAD


Outcome Measures
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Primary Outcome Measures :
  1. Change in Physical Activity of Care Recipient [ Time Frame: Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months ]
    # of minutes per week of exercise care recipient participated in

  2. Change in Physical Activity of Caregiver [ Time Frame: Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months ]
    # of minutes per week of exercise caregiver participated in

  3. Change in Physical Functioning of Care Recipient [ Time Frame: Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months ]
    # of days care recipient experienced restriction in activities

  4. Change in Physical Functioning of Caregiver [ Time Frame: Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months ]
    # of days caregiver experienced restriction in activities

  5. 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


Secondary Outcome Measures :
  1. Change in Health-Related Quality of Life (HRQOL) of Care Recipient [ Time Frame: Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months ]
    Medical outcomes study short form (MOS SF-36)

  2. Change in Health-Related Quality of Life (HRQOL) of Caregiver [ Time Frame: Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months ]
    Medical outcomes study short form (MOS SF-36)

  3. Change in Quality of Life (QOL-AD) of Care Recipient [ Time Frame: Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months ]
    QOL-AD measure

  4. Change in Health-Related Quality of Life (QOL-AD) of Caregiver [ Time Frame: Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months ]
    Medical outcomes study short form (MOS SF-36)

  5. Change in Rate of Care-Recipient Behavioral Disturbances [ Time Frame: Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months ]
    Revised Memory and Behavior Problem Checklist (RMBPC) assess presence and frequency of memory, depressive, disruptive behavior and caregiver response


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03550131


Locations
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United States, Washington
University of Washington
Seattle, Washington, United States, 98105
Sponsors and Collaborators
University of Washington
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Karen Fredriksen-Goldsen, PhD University of Washington
More Information
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Responsible Party: Karen Fredriksen Goldsen, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT03550131    
Other Study ID Numbers: STUDY00003076
1R01AG055488-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: February 14, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Karen Fredriksen Goldsen, University of Washington:
LGBT
Additional relevant MeSH terms:
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Parkinson Disease
Alzheimer Disease
Dementia
Dementia, Vascular
Lewy Body Disease
Cognitive Dysfunction
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
 Neurodegenerative Diseases
Tauopathies
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases