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Completed

NCT Number: NCT03550131

Innovations in Dementia Empowerment and Action

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).

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Key information

Conditions

Alzheimer Disease Arterial Occlusive Diseases Arteriosclerosis Basal Ganglia Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cognition Disorders Cognitive Dysfunction Dementia Dementia, Vascular Intracranial Arterial Diseases Intracranial Arteriosclerosis Leukoencephalopathies Lewy Body Dementia Lewy Body Disease Mental Disorders Mild Cognitive Impairment Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinson Disease Dementia Parkinsonian Disorders Synucleinopathies Tauopathies Vascular Dementia Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for care receiver

  • Age at enrollment is 50 years of age or older
  • Have dementia, (e.g., Alzheimer's disease, mild cognitive impairment, 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.

Treatment and study plan

Innovations in Dementia Empowerment and Action (IDEA)

Behavioral

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: Personalized RDAD

Reducing Disabilities in Alzheimer's Disease (RDAD)

Behavioral

The RDAD intervention includes behavioral management training for caregiver and activities and exercise training for caregiver and care receiver.

Other names: Standard RDAD

Primary outcomes

  1. Change in Physical Activity of Care Recipient

    Time frame: Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months

    Measured by the days of aerobic activity for at least 30 minutes in the past week with higher numbers indicating more days of activity.

Secondary outcomes

  1. Depression of Care Partner: Center for Epidemiological Studies-Depression Scale (CESD-10)

    Time frame: Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months

    Assessed using the summed score on the 10-item Center for Epidemiological Studies-Depression Scale (CESD-10). Range of scores 0-27 with higher scores indicating higher levels of depression.

  2. Quality of Life in Alzheimer's Disease, Care Recipient

    Time frame: Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months

    Quality of life was evaluated using the summed score of the Quality of Life in Alzheimer's Disease (QOL-AD), a 13-item measure. Range of scores 13-52 with higher scores equal better quality of life.

  3. Memory-Related Disturbance, Care Recipient

    Time frame: Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months

    Assessed using mean scores on the memory-related subscale (7 items) of the 24-item Revised Memory and Behavior Problem Checklist (RMBPC). Ranges 0 -3. Higher scores indicate higher memory-related behavioral disturbances.

  4. Physical Functioning of Care Recipient: Medical Outcomes Study 36-Item Short Form (SF-36)

    Time frame: Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months

    Physical functioning was assessed using the mean score of the Physical Functioning subscale of the Medical Outcomes Study 36-Item Short Form (SF-36), consisting of 10 items asking about degree to which health status limits activities including walking, climbing, lifting, and bathing or dressing oneself. The summary score ranges from 0 to 100. Higher scores indicate higher physical functioning.

  5. Perceived Stress of Care Partner

    Time frame: Baseline, 6 weeks (Pre-treatment), 13 weeks (Post-treatment), 30 weeks, 13 months

    Assessed with mean scores of the 4-item Perceived Stress Scale. The summary score ranges from 0 to 4. Higher scores indicate more stress.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Aging With Pride: Innovations in Dementia Empowerment and Action

Acronym: IDEA

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jun 8, 2018
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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