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Innovations in Dementia Empowerment and Action

Aging With Pride: Innovations in Dementia Empowerment and Action

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03550131
Acronym
IDEA
Enrollment
322
Registered
2018-06-08
Start date
2018-12-05
Completion date
2023-05-16
Last updated
2024-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

LGBT

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).

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.

Interventions

BEHAVIORALInnovations 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.

BEHAVIORALReducing 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.

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Participants receiving intervention will not be informed whether it is the standard or personalized treatment.

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.

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Physical Activity of Care RecipientBaseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 monthsMeasured by the days of aerobic activity for at least 30 minutes in the past week with higher numbers indicating more days of activity.

Secondary

MeasureTime frameDescription
Depression of Care Partner: Center for Epidemiological Studies-Depression Scale (CESD-10)Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 monthsAssessed 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.
Quality of Life in Alzheimer's Disease, Care RecipientBaseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 monthsQuality 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.
Memory-Related Disturbance, Care RecipientBaseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 monthsAssessed 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.
Physical Functioning of Care Recipient: Medical Outcomes Study 36-Item Short Form (SF-36)Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 monthsPhysical 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.
Perceived Stress of Care PartnerBaseline, 6 weeks (Pre-treatment), 13 weeks (Post-treatment), 30 weeks, 13 monthsAssessed with mean scores of the 4-item Perceived Stress Scale. The summary score ranges from 0 to 4. Higher scores indicate more stress.

Countries

United States

Participant flow

Recruitment details

Participants recruited from multiple sources using a multifaceted approach, including direct referrals from community agencies providing aging and health services using presentations, flyers, newsletters, and social media.

Pre-assignment details

A total of 161 dyad pairs (i.e., a person with dementia and their care partner) were enrolled and randomly assigned to either the personalized or standard arm.

Participants by arm

ArmCount
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 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.
80
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 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.
76
Total156

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath of person with dementia48
Overall StudyIllness of dyad member102
Overall StudyLost to Follow-up1624
Overall StudyWithdrawal by Subject3628

Baseline characteristics

CharacteristicPersonalized InterventionStandard InterventionTotal
Age, Continuous
Care partner (CP)
62.15 years
STANDARD_DEVIATION 13.04
62.03 years
STANDARD_DEVIATION 13.34
62.09 years
STANDARD_DEVIATION 13.15
Age, Continuous
Care recipient (CR)
69.36 years
STANDARD_DEVIATION 10.11
72.19 years
STANDARD_DEVIATION 8.26
70.75 years
STANDARD_DEVIATION 9.32
Ethnicity (NIH/OMB)
Care partner (CP)
Hispanic or Latino
7 Participants5 Participants12 Participants
Ethnicity (NIH/OMB)
Care partner (CP)
Not Hispanic or Latino
73 Participants71 Participants144 Participants
Ethnicity (NIH/OMB)
Care partner (CP)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Care recipient (CR)
Hispanic or Latino
9 Participants4 Participants13 Participants
Ethnicity (NIH/OMB)
Care recipient (CR)
Not Hispanic or Latino
71 Participants72 Participants143 Participants
Ethnicity (NIH/OMB)
Care recipient (CR)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Care partner (CP)
American Indian or Alaska Native
0 Participants3 Participants3 Participants
Race (NIH/OMB)
Care partner (CP)
Asian
3 Participants3 Participants6 Participants
Race (NIH/OMB)
Care partner (CP)
Black or African American
4 Participants3 Participants7 Participants
Race (NIH/OMB)
Care partner (CP)
More than one race
10 Participants6 Participants16 Participants
Race (NIH/OMB)
Care partner (CP)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Care partner (CP)
Unknown or Not Reported
1 Participants3 Participants4 Participants
Race (NIH/OMB)
Care partner (CP)
White
62 Participants58 Participants120 Participants
Race (NIH/OMB)
Care recipient (CR)
American Indian or Alaska Native
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Care recipient (CR)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Care recipient (CR)
Black or African American
7 Participants3 Participants10 Participants
Race (NIH/OMB)
Care recipient (CR)
More than one race
4 Participants3 Participants7 Participants
Race (NIH/OMB)
Care recipient (CR)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Care recipient (CR)
Unknown or Not Reported
2 Participants0 Participants2 Participants
Race (NIH/OMB)
Care recipient (CR)
White
67 Participants68 Participants135 Participants
Sex/Gender, Customized
Care partner (CP)
Diverse
5 Participants6 Participants11 Participants
Sex/Gender, Customized
Care partner (CP)
Men
30 Participants32 Participants62 Participants
Sex/Gender, Customized
Care partner (CP)
Women
45 Participants38 Participants83 Participants
Sex/Gender, Customized
Care recipient (CR)
Diverse
0 Participants3 Participants3 Participants
Sex/Gender, Customized
Care recipient (CR)
Men
33 Participants28 Participants61 Participants
Sex/Gender, Customized
Care recipient (CR)
Women
47 Participants45 Participants92 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
2 / 800 / 804 / 760 / 76
other
Total, other adverse events
0 / 800 / 800 / 760 / 76
serious
Total, serious adverse events
0 / 800 / 800 / 760 / 76

Outcome results

Primary

Change in Physical Activity of Care Recipient

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

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

ArmMeasureGroupValue (MEAN)Dispersion
Personalized InterventionChange in Physical Activity of Care Recipient6 weeks3.01 daysStandard Deviation 2.66
Personalized InterventionChange in Physical Activity of Care Recipient30 weeks3.67 daysStandard Deviation 2.67
Personalized InterventionChange in Physical Activity of Care Recipient13 weeks3.81 daysStandard Deviation 2.4
Personalized InterventionChange in Physical Activity of Care Recipient13 months2.96 daysStandard Deviation 2.51
Personalized InterventionChange in Physical Activity of Care RecipientBaseline3.20 daysStandard Deviation 2.56
Standard InterventionChange in Physical Activity of Care Recipient13 months2.96 daysStandard Deviation 2.51
Standard InterventionChange in Physical Activity of Care RecipientBaseline2.76 daysStandard Deviation 2.53
Standard InterventionChange in Physical Activity of Care Recipient6 weeks2.66 daysStandard Deviation 2.53
Standard InterventionChange in Physical Activity of Care Recipient13 weeks3.79 daysStandard Deviation 2.54
Standard InterventionChange in Physical Activity of Care Recipient30 weeks3.21 daysStandard Deviation 2.6
Secondary

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

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.

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

ArmMeasureGroupValue (MEAN)Dispersion
Personalized InterventionDepression of Care Partner: Center for Epidemiological Studies-Depression Scale (CESD-10)6 weeks6.76 score on a scaleStandard Deviation 6.29
Personalized InterventionDepression of Care Partner: Center for Epidemiological Studies-Depression Scale (CESD-10)30 weeks6.43 score on a scaleStandard Deviation 5.98
Personalized InterventionDepression of Care Partner: Center for Epidemiological Studies-Depression Scale (CESD-10)13 weeks5.63 score on a scaleStandard Deviation 5.58
Personalized InterventionDepression of Care Partner: Center for Epidemiological Studies-Depression Scale (CESD-10)13 months5.23 score on a scaleStandard Deviation 5.58
Personalized InterventionDepression of Care Partner: Center for Epidemiological Studies-Depression Scale (CESD-10)Baseline7.38 score on a scaleStandard Deviation 5.45
Standard InterventionDepression of Care Partner: Center for Epidemiological Studies-Depression Scale (CESD-10)13 months5.70 score on a scaleStandard Deviation 6.22
Standard InterventionDepression of Care Partner: Center for Epidemiological Studies-Depression Scale (CESD-10)Baseline6.98 score on a scaleStandard Deviation 5.57
Standard InterventionDepression of Care Partner: Center for Epidemiological Studies-Depression Scale (CESD-10)6 weeks6.95 score on a scaleStandard Deviation 5.01
Standard InterventionDepression of Care Partner: Center for Epidemiological Studies-Depression Scale (CESD-10)13 weeks6.38 score on a scaleStandard Deviation 5.22
Standard InterventionDepression of Care Partner: Center for Epidemiological Studies-Depression Scale (CESD-10)30 weeks7.21 score on a scaleStandard Deviation 4.62
Secondary

Memory-Related Disturbance, Care Recipient

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.

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

ArmMeasureGroupValue (MEAN)Dispersion
Personalized InterventionMemory-Related Disturbance, Care Recipient6 weeks1.21 score on a scaleStandard Deviation 0.8
Personalized InterventionMemory-Related Disturbance, Care Recipient30 weeks1.21 score on a scaleStandard Deviation 0.85
Personalized InterventionMemory-Related Disturbance, Care Recipient13 weeks1.10 score on a scaleStandard Deviation 0.8
Personalized InterventionMemory-Related Disturbance, Care Recipient13 months1.29 score on a scaleStandard Deviation 0.93
Personalized InterventionMemory-Related Disturbance, Care RecipientBaseline1.24 score on a scaleStandard Deviation 0.78
Standard InterventionMemory-Related Disturbance, Care Recipient13 months1.14 score on a scaleStandard Deviation 0.84
Standard InterventionMemory-Related Disturbance, Care RecipientBaseline1.19 score on a scaleStandard Deviation 0.72
Standard InterventionMemory-Related Disturbance, Care Recipient6 weeks1.15 score on a scaleStandard Deviation 0.73
Standard InterventionMemory-Related Disturbance, Care Recipient13 weeks1.10 score on a scaleStandard Deviation 0.76
Standard InterventionMemory-Related Disturbance, Care Recipient30 weeks1.14 score on a scaleStandard Deviation 0.79
Secondary

Perceived Stress of Care Partner

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

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

ArmMeasureGroupValue (MEAN)Dispersion
Personalized InterventionPerceived Stress of Care Partner6 weeks2.46 score on a scaleStandard Deviation 0.27
Personalized InterventionPerceived Stress of Care Partner30 weeks2.43 score on a scaleStandard Deviation 0.29
Personalized InterventionPerceived Stress of Care Partner13 weeks2.44 score on a scaleStandard Deviation 0.29
Personalized InterventionPerceived Stress of Care Partner52 weeks2.41 score on a scaleStandard Deviation 0.23
Personalized InterventionPerceived Stress of Care PartnerBaseline2.39 score on a scaleStandard Deviation 0.28
Standard InterventionPerceived Stress of Care Partner52 weeks2.41 score on a scaleStandard Deviation 0.25
Standard InterventionPerceived Stress of Care PartnerBaseline2.42 score on a scaleStandard Deviation 0.25
Standard InterventionPerceived Stress of Care Partner6 weeks2.44 score on a scaleStandard Deviation 0.22
Standard InterventionPerceived Stress of Care Partner13 weeks2.46 score on a scaleStandard Deviation 0.3
Standard InterventionPerceived Stress of Care Partner30 weeks2.43 score on a scaleStandard Deviation 0.26
Secondary

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

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.

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

ArmMeasureGroupValue (MEAN)Dispersion
Personalized InterventionPhysical Functioning of Care Recipient: Medical Outcomes Study 36-Item Short Form (SF-36)6 weeks58.15 score on a scaleStandard Deviation 28.98
Personalized InterventionPhysical Functioning of Care Recipient: Medical Outcomes Study 36-Item Short Form (SF-36)30 weeks58.17 score on a scaleStandard Deviation 30.13
Personalized InterventionPhysical Functioning of Care Recipient: Medical Outcomes Study 36-Item Short Form (SF-36)13 weeks59.95 score on a scaleStandard Deviation 28.4
Personalized InterventionPhysical Functioning of Care Recipient: Medical Outcomes Study 36-Item Short Form (SF-36)13 months59.79 score on a scaleStandard Deviation 29.98
Personalized InterventionPhysical Functioning of Care Recipient: Medical Outcomes Study 36-Item Short Form (SF-36)baseline58.65 score on a scaleStandard Deviation 28.37
Standard InterventionPhysical Functioning of Care Recipient: Medical Outcomes Study 36-Item Short Form (SF-36)13 months57.45 score on a scaleStandard Deviation 30.62
Standard InterventionPhysical Functioning of Care Recipient: Medical Outcomes Study 36-Item Short Form (SF-36)baseline58.46 score on a scaleStandard Deviation 31.04
Standard InterventionPhysical Functioning of Care Recipient: Medical Outcomes Study 36-Item Short Form (SF-36)6 weeks59.16 score on a scaleStandard Deviation 30.19
Standard InterventionPhysical Functioning of Care Recipient: Medical Outcomes Study 36-Item Short Form (SF-36)13 weeks61.24 score on a scaleStandard Deviation 31.7
Standard InterventionPhysical Functioning of Care Recipient: Medical Outcomes Study 36-Item Short Form (SF-36)30 weeks57.79 score on a scaleStandard Deviation 32
Secondary

Quality of Life in Alzheimer's Disease, Care Recipient

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.

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

ArmMeasureGroupValue (MEAN)Dispersion
Personalized InterventionQuality of Life in Alzheimer's Disease, Care Recipient6 weeks33.94 score on a scaleStandard Deviation 5.98
Personalized InterventionQuality of Life in Alzheimer's Disease, Care Recipient30 weeks35.46 score on a scaleStandard Deviation 6.12
Personalized InterventionQuality of Life in Alzheimer's Disease, Care Recipient13 weeks36.49 score on a scaleStandard Deviation 6.42
Personalized InterventionQuality of Life in Alzheimer's Disease, Care Recipient13 months33.94 score on a scaleStandard Deviation 7.31
Personalized InterventionQuality of Life in Alzheimer's Disease, Care RecipientBaseline33.29 score on a scaleStandard Deviation 6.46
Standard InterventionQuality of Life in Alzheimer's Disease, Care Recipient13 months35.37 score on a scaleStandard Deviation 6.82
Standard InterventionQuality of Life in Alzheimer's Disease, Care RecipientBaseline34.71 score on a scaleStandard Deviation 7.13
Standard InterventionQuality of Life in Alzheimer's Disease, Care Recipient6 weeks34.07 score on a scaleStandard Deviation 7.05
Standard InterventionQuality of Life in Alzheimer's Disease, Care Recipient13 weeks35.37 score on a scaleStandard Deviation 6.87
Standard InterventionQuality of Life in Alzheimer's Disease, Care Recipient30 weeks34.79 score on a scaleStandard Deviation 6.8

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026