Alzheimer Disease, Dementia, Lewy Body Dementia, Mild Cognitive Impairment, Parkinson Disease Dementia, Vascular Dementia
Conditions
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
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.
The RDAD intervention includes behavioral management training for caregiver and activities and exercise training for caregiver and care receiver.
Sponsors
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| Change in Physical Activity of Care Recipient | 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
| Measure | Time frame | Description |
|---|---|---|
| Depression of Care Partner: Center for Epidemiological Studies-Depression Scale (CESD-10) | 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. |
| Quality of Life in Alzheimer's Disease, Care Recipient | 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. |
| Memory-Related Disturbance, Care Recipient | 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. |
| 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 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. |
| Perceived Stress of Care Partner | 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. |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 156 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death of person with dementia | 4 | 8 |
| Overall Study | Illness of dyad member | 10 | 2 |
| Overall Study | Lost to Follow-up | 16 | 24 |
| Overall Study | Withdrawal by Subject | 36 | 28 |
Baseline characteristics
| Characteristic | Personalized Intervention | Standard Intervention | Total |
|---|---|---|---|
| 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 Participants | 5 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Care partner (CP) Not Hispanic or Latino | 73 Participants | 71 Participants | 144 Participants |
| Ethnicity (NIH/OMB) Care partner (CP) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Care recipient (CR) Hispanic or Latino | 9 Participants | 4 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Care recipient (CR) Not Hispanic or Latino | 71 Participants | 72 Participants | 143 Participants |
| Ethnicity (NIH/OMB) Care recipient (CR) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Care partner (CP) American Indian or Alaska Native | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Care partner (CP) Asian | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Care partner (CP) Black or African American | 4 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) Care partner (CP) More than one race | 10 Participants | 6 Participants | 16 Participants |
| Race (NIH/OMB) Care partner (CP) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Care partner (CP) Unknown or Not Reported | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Care partner (CP) White | 62 Participants | 58 Participants | 120 Participants |
| Race (NIH/OMB) Care recipient (CR) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Care recipient (CR) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Care recipient (CR) Black or African American | 7 Participants | 3 Participants | 10 Participants |
| Race (NIH/OMB) Care recipient (CR) More than one race | 4 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) Care recipient (CR) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Care recipient (CR) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Care recipient (CR) White | 67 Participants | 68 Participants | 135 Participants |
| Sex/Gender, Customized Care partner (CP) Diverse | 5 Participants | 6 Participants | 11 Participants |
| Sex/Gender, Customized Care partner (CP) Men | 30 Participants | 32 Participants | 62 Participants |
| Sex/Gender, Customized Care partner (CP) Women | 45 Participants | 38 Participants | 83 Participants |
| Sex/Gender, Customized Care recipient (CR) Diverse | 0 Participants | 3 Participants | 3 Participants |
| Sex/Gender, Customized Care recipient (CR) Men | 33 Participants | 28 Participants | 61 Participants |
| Sex/Gender, Customized Care recipient (CR) Women | 47 Participants | 45 Participants | 92 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 80 | 0 / 80 | 4 / 76 | 0 / 76 |
| other Total, other adverse events | 0 / 80 | 0 / 80 | 0 / 76 | 0 / 76 |
| serious Total, serious adverse events | 0 / 80 | 0 / 80 | 0 / 76 | 0 / 76 |
Outcome results
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Personalized Intervention | Change in Physical Activity of Care Recipient | 6 weeks | 3.01 days | Standard Deviation 2.66 |
| Personalized Intervention | Change in Physical Activity of Care Recipient | 30 weeks | 3.67 days | Standard Deviation 2.67 |
| Personalized Intervention | Change in Physical Activity of Care Recipient | 13 weeks | 3.81 days | Standard Deviation 2.4 |
| Personalized Intervention | Change in Physical Activity of Care Recipient | 13 months | 2.96 days | Standard Deviation 2.51 |
| Personalized Intervention | Change in Physical Activity of Care Recipient | Baseline | 3.20 days | Standard Deviation 2.56 |
| Standard Intervention | Change in Physical Activity of Care Recipient | 13 months | 2.96 days | Standard Deviation 2.51 |
| Standard Intervention | Change in Physical Activity of Care Recipient | Baseline | 2.76 days | Standard Deviation 2.53 |
| Standard Intervention | Change in Physical Activity of Care Recipient | 6 weeks | 2.66 days | Standard Deviation 2.53 |
| Standard Intervention | Change in Physical Activity of Care Recipient | 13 weeks | 3.79 days | Standard Deviation 2.54 |
| Standard Intervention | Change in Physical Activity of Care Recipient | 30 weeks | 3.21 days | Standard Deviation 2.6 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Personalized Intervention | Depression of Care Partner: Center for Epidemiological Studies-Depression Scale (CESD-10) | 6 weeks | 6.76 score on a scale | Standard Deviation 6.29 |
| Personalized Intervention | Depression of Care Partner: Center for Epidemiological Studies-Depression Scale (CESD-10) | 30 weeks | 6.43 score on a scale | Standard Deviation 5.98 |
| Personalized Intervention | Depression of Care Partner: Center for Epidemiological Studies-Depression Scale (CESD-10) | 13 weeks | 5.63 score on a scale | Standard Deviation 5.58 |
| Personalized Intervention | Depression of Care Partner: Center for Epidemiological Studies-Depression Scale (CESD-10) | 13 months | 5.23 score on a scale | Standard Deviation 5.58 |
| Personalized Intervention | Depression of Care Partner: Center for Epidemiological Studies-Depression Scale (CESD-10) | Baseline | 7.38 score on a scale | Standard Deviation 5.45 |
| Standard Intervention | Depression of Care Partner: Center for Epidemiological Studies-Depression Scale (CESD-10) | 13 months | 5.70 score on a scale | Standard Deviation 6.22 |
| Standard Intervention | Depression of Care Partner: Center for Epidemiological Studies-Depression Scale (CESD-10) | Baseline | 6.98 score on a scale | Standard Deviation 5.57 |
| Standard Intervention | Depression of Care Partner: Center for Epidemiological Studies-Depression Scale (CESD-10) | 6 weeks | 6.95 score on a scale | Standard Deviation 5.01 |
| Standard Intervention | Depression of Care Partner: Center for Epidemiological Studies-Depression Scale (CESD-10) | 13 weeks | 6.38 score on a scale | Standard Deviation 5.22 |
| Standard Intervention | Depression of Care Partner: Center for Epidemiological Studies-Depression Scale (CESD-10) | 30 weeks | 7.21 score on a scale | Standard Deviation 4.62 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Personalized Intervention | Memory-Related Disturbance, Care Recipient | 6 weeks | 1.21 score on a scale | Standard Deviation 0.8 |
| Personalized Intervention | Memory-Related Disturbance, Care Recipient | 30 weeks | 1.21 score on a scale | Standard Deviation 0.85 |
| Personalized Intervention | Memory-Related Disturbance, Care Recipient | 13 weeks | 1.10 score on a scale | Standard Deviation 0.8 |
| Personalized Intervention | Memory-Related Disturbance, Care Recipient | 13 months | 1.29 score on a scale | Standard Deviation 0.93 |
| Personalized Intervention | Memory-Related Disturbance, Care Recipient | Baseline | 1.24 score on a scale | Standard Deviation 0.78 |
| Standard Intervention | Memory-Related Disturbance, Care Recipient | 13 months | 1.14 score on a scale | Standard Deviation 0.84 |
| Standard Intervention | Memory-Related Disturbance, Care Recipient | Baseline | 1.19 score on a scale | Standard Deviation 0.72 |
| Standard Intervention | Memory-Related Disturbance, Care Recipient | 6 weeks | 1.15 score on a scale | Standard Deviation 0.73 |
| Standard Intervention | Memory-Related Disturbance, Care Recipient | 13 weeks | 1.10 score on a scale | Standard Deviation 0.76 |
| Standard Intervention | Memory-Related Disturbance, Care Recipient | 30 weeks | 1.14 score on a scale | Standard Deviation 0.79 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Personalized Intervention | Perceived Stress of Care Partner | 6 weeks | 2.46 score on a scale | Standard Deviation 0.27 |
| Personalized Intervention | Perceived Stress of Care Partner | 30 weeks | 2.43 score on a scale | Standard Deviation 0.29 |
| Personalized Intervention | Perceived Stress of Care Partner | 13 weeks | 2.44 score on a scale | Standard Deviation 0.29 |
| Personalized Intervention | Perceived Stress of Care Partner | 52 weeks | 2.41 score on a scale | Standard Deviation 0.23 |
| Personalized Intervention | Perceived Stress of Care Partner | Baseline | 2.39 score on a scale | Standard Deviation 0.28 |
| Standard Intervention | Perceived Stress of Care Partner | 52 weeks | 2.41 score on a scale | Standard Deviation 0.25 |
| Standard Intervention | Perceived Stress of Care Partner | Baseline | 2.42 score on a scale | Standard Deviation 0.25 |
| Standard Intervention | Perceived Stress of Care Partner | 6 weeks | 2.44 score on a scale | Standard Deviation 0.22 |
| Standard Intervention | Perceived Stress of Care Partner | 13 weeks | 2.46 score on a scale | Standard Deviation 0.3 |
| Standard Intervention | Perceived Stress of Care Partner | 30 weeks | 2.43 score on a scale | Standard Deviation 0.26 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Personalized Intervention | Physical Functioning of Care Recipient: Medical Outcomes Study 36-Item Short Form (SF-36) | 6 weeks | 58.15 score on a scale | Standard Deviation 28.98 |
| Personalized Intervention | Physical Functioning of Care Recipient: Medical Outcomes Study 36-Item Short Form (SF-36) | 30 weeks | 58.17 score on a scale | Standard Deviation 30.13 |
| Personalized Intervention | Physical Functioning of Care Recipient: Medical Outcomes Study 36-Item Short Form (SF-36) | 13 weeks | 59.95 score on a scale | Standard Deviation 28.4 |
| Personalized Intervention | Physical Functioning of Care Recipient: Medical Outcomes Study 36-Item Short Form (SF-36) | 13 months | 59.79 score on a scale | Standard Deviation 29.98 |
| Personalized Intervention | Physical Functioning of Care Recipient: Medical Outcomes Study 36-Item Short Form (SF-36) | baseline | 58.65 score on a scale | Standard Deviation 28.37 |
| Standard Intervention | Physical Functioning of Care Recipient: Medical Outcomes Study 36-Item Short Form (SF-36) | 13 months | 57.45 score on a scale | Standard Deviation 30.62 |
| Standard Intervention | Physical Functioning of Care Recipient: Medical Outcomes Study 36-Item Short Form (SF-36) | baseline | 58.46 score on a scale | Standard Deviation 31.04 |
| Standard Intervention | Physical Functioning of Care Recipient: Medical Outcomes Study 36-Item Short Form (SF-36) | 6 weeks | 59.16 score on a scale | Standard Deviation 30.19 |
| Standard Intervention | Physical Functioning of Care Recipient: Medical Outcomes Study 36-Item Short Form (SF-36) | 13 weeks | 61.24 score on a scale | Standard Deviation 31.7 |
| Standard Intervention | Physical Functioning of Care Recipient: Medical Outcomes Study 36-Item Short Form (SF-36) | 30 weeks | 57.79 score on a scale | Standard Deviation 32 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Personalized Intervention | Quality of Life in Alzheimer's Disease, Care Recipient | 6 weeks | 33.94 score on a scale | Standard Deviation 5.98 |
| Personalized Intervention | Quality of Life in Alzheimer's Disease, Care Recipient | 30 weeks | 35.46 score on a scale | Standard Deviation 6.12 |
| Personalized Intervention | Quality of Life in Alzheimer's Disease, Care Recipient | 13 weeks | 36.49 score on a scale | Standard Deviation 6.42 |
| Personalized Intervention | Quality of Life in Alzheimer's Disease, Care Recipient | 13 months | 33.94 score on a scale | Standard Deviation 7.31 |
| Personalized Intervention | Quality of Life in Alzheimer's Disease, Care Recipient | Baseline | 33.29 score on a scale | Standard Deviation 6.46 |
| Standard Intervention | Quality of Life in Alzheimer's Disease, Care Recipient | 13 months | 35.37 score on a scale | Standard Deviation 6.82 |
| Standard Intervention | Quality of Life in Alzheimer's Disease, Care Recipient | Baseline | 34.71 score on a scale | Standard Deviation 7.13 |
| Standard Intervention | Quality of Life in Alzheimer's Disease, Care Recipient | 6 weeks | 34.07 score on a scale | Standard Deviation 7.05 |
| Standard Intervention | Quality of Life in Alzheimer's Disease, Care Recipient | 13 weeks | 35.37 score on a scale | Standard Deviation 6.87 |
| Standard Intervention | Quality of Life in Alzheimer's Disease, Care Recipient | 30 weeks | 34.79 score on a scale | Standard Deviation 6.8 |