Innovations in Dementia Empowerment and Action

Alzheimer Disease Clinical Trial

— IDEA  

Official title:

Aging With Pride: Innovations in Dementia Empowerment and Action

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03550131
• Other study ID #: STUDY00003076
• Secondary ID: 1R01AG055488-01A
• Status: Completed
• Phase: N/A
• Start date: December 5, 2018
• Est. completion date: May 16, 2023

Study information

• Verified date: September 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 322
• Est. completion date: May 16, 2023
• Est. primary completion date: May 16, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Dementia
• Dementia, Vascular
• Lewy Body Dementia
• Lewy Body Disease
• Mild Cognitive Impairment
• Parkinson Disease
• Parkinson Disease Dementia
• Vascular Dementia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Physical Activity of Care Recipient	Days exercise >= 30 min in the past week	Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months
Primary	Change in Physical Activity of Caregiver	Days exercise >= 30 min in the past week	Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months
Primary	Change in Physical Functioning of Care Recipient	Medical outcomes study short form (MOS SF-36)	Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months
Primary	Change in Physical Functioning of Caregiver	Medical outcomes study short form (MOS SF-36)	Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months
Primary	Change in Perceived Stress (PSS) of Caregiver	14-item self-report measure designed to measure nonspecific, appraised stress during the past month	Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months
Secondary	Change in Depressive Symptomatology of Caregiver	CESD-10	Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months
Secondary	Change in Quality of Life (QOL-AD) of Care Recipient	QOL-AD measure	Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months
Secondary	Change in Rate of Care-Recipient Behavioral Disturbances	Revised Memory and Behavior Problem Checklist (RMBPC) assess presence and frequency of memory, depressive, disruptive behavior and caregiver response	Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months