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Innovations in Dementia Empowerment and Action (IDEA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03550131
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
Karen Fredriksen Goldsen, University of Washington

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 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 : December 31, 2020
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

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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
  • Self-identify as LGBT (or sexual or gender non-binary or same sex sexual behavior)
  • Have dementia, including Alzheimer's disease
  • Living in the community, not in a care facility.
  • No more than 150 minutes a week of moderate intensity exercise.

Inclusion criteria for care giver

  • Provide care to the care recipient with dementia.
  • Unpaid
  • Live in the community, not in a care facility

Neither care receiver nor caregiver:

  • No known terminal illness (with death anticipated within the next 12 months)
  • No hospitalization for a psychiatric disorder in the 12 months prior to baseline
  • Not Parkinson's disease, Huntington's disease, traumatic brain injury, or stroke which resulted in persistent muscle weakness or paralysis.
  • Not blind, or unable to hear even with hearing aids, or unable to walk.
  • No plans to move out of study geographic area during the next 4 months.
  • Any physical limitations/chronic conditions preventing participation in an exercise program.

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


Contacts
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Contact: Amy Cunningham, MS 1-888-655-6646 ageidea@uw.edu

Locations
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United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98105
Contact: Amy Cunningham, MS    888-655-6646    ageidea@uw.edu   
Sponsors and Collaborators
University of Washington
Investigators
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Principal Investigator: Karen Fredriksen-Goldsen, PhD University of Washington
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Responsible Party: Karen Fredriksen Goldsen, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT03550131    
Other Study ID Numbers: STUDY00003076
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: April 2020

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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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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders