Trial Outcomes & Findings for Innovations in Dementia Empowerment and Action (NCT NCT03550131)
NCT ID: NCT03550131
Last Updated: 2024-07-25
Results Overview
Measured by the days of aerobic activity for at least 30 minutes in the past week with higher numbers indicating more days of activity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
322 participants
Primary outcome timeframe
Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months
Results posted on
2024-07-25
Participant Flow
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.
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.
Participant milestones
| Measure |
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 lesbian, gay, bisexual, and transgender (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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
162
|
160
|
|
Overall Study
Baseline, CR
|
80
|
76
|
|
Overall Study
Baseline, CP
|
80
|
76
|
|
Overall Study
6 Week (Pre-Treatment), CR
|
70
|
71
|
|
Overall Study
6 Week (Pre-Treatment), CP
|
70
|
71
|
|
Overall Study
13 Week (Post-treatment), CR
|
57
|
63
|
|
Overall Study
13 Week (Post-treatment), CP
|
57
|
63
|
|
Overall Study
30 Week Follow up, CR
|
53
|
61
|
|
Overall Study
30 Week Follow up, CP
|
53
|
61
|
|
Overall Study
13 Month Follow up, CR
|
48
|
49
|
|
Overall Study
13 Month Follow up, CP
|
48
|
49
|
|
Overall Study
COMPLETED
|
96
|
98
|
|
Overall Study
NOT COMPLETED
|
66
|
62
|
Reasons for withdrawal
| Measure |
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 lesbian, gay, bisexual, and transgender (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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
16
|
24
|
|
Overall Study
Withdrawal by Subject
|
36
|
28
|
|
Overall Study
Illness of dyad member
|
10
|
2
|
|
Overall Study
Death of person with dementia
|
4
|
8
|
Baseline Characteristics
The overall number includes both care recipients and care partners.
Baseline characteristics by cohort
| Measure |
Personalized Intervention
n=80 Participants
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.
|
Standard Intervention
n=76 Participants
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.
|
Total
n=156 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Care recipient (CR)
|
69.36 years
STANDARD_DEVIATION 10.11 • n=5 Participants • The overall number includes both care recipients and care partners.
|
72.19 years
STANDARD_DEVIATION 8.26 • n=7 Participants • The overall number includes both care recipients and care partners.
|
70.75 years
STANDARD_DEVIATION 9.32 • n=5 Participants • The overall number includes both care recipients and care partners.
|
|
Age, Continuous
Care partner (CP)
|
62.15 years
STANDARD_DEVIATION 13.04 • n=5 Participants • The overall number includes both care recipients and care partners.
|
62.03 years
STANDARD_DEVIATION 13.34 • n=7 Participants • The overall number includes both care recipients and care partners.
|
62.09 years
STANDARD_DEVIATION 13.15 • n=5 Participants • The overall number includes both care recipients and care partners.
|
|
Sex/Gender, Customized
Care recipient (CR) · Women
|
47 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
45 Participants
n=7 Participants • The overall number includes both care recipients and care partners.
|
92 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
|
Sex/Gender, Customized
Care recipient (CR) · Men
|
33 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
28 Participants
n=7 Participants • The overall number includes both care recipients and care partners.
|
61 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
|
Sex/Gender, Customized
Care recipient (CR) · Diverse
|
0 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
3 Participants
n=7 Participants • The overall number includes both care recipients and care partners.
|
3 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
|
Sex/Gender, Customized
Care partner (CP) · Women
|
45 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
38 Participants
n=7 Participants • The overall number includes both care recipients and care partners.
|
83 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
|
Sex/Gender, Customized
Care partner (CP) · Men
|
30 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
32 Participants
n=7 Participants • The overall number includes both care recipients and care partners.
|
62 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
|
Sex/Gender, Customized
Care partner (CP) · Diverse
|
5 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
6 Participants
n=7 Participants • The overall number includes both care recipients and care partners.
|
11 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
|
Ethnicity (NIH/OMB)
Care recipient (CR) · Hispanic or Latino
|
9 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
4 Participants
n=7 Participants • The overall number includes both care recipients and care partners.
|
13 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
|
Ethnicity (NIH/OMB)
Care recipient (CR) · Not Hispanic or Latino
|
71 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
72 Participants
n=7 Participants • The overall number includes both care recipients and care partners.
|
143 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
|
Ethnicity (NIH/OMB)
Care recipient (CR) · Unknown or Not Reported
|
0 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
0 Participants
n=7 Participants • The overall number includes both care recipients and care partners.
|
0 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
|
Ethnicity (NIH/OMB)
Care partner (CP) · Hispanic or Latino
|
7 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
5 Participants
n=7 Participants • The overall number includes both care recipients and care partners.
|
12 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
|
Ethnicity (NIH/OMB)
Care partner (CP) · Not Hispanic or Latino
|
73 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
71 Participants
n=7 Participants • The overall number includes both care recipients and care partners.
|
144 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
|
Ethnicity (NIH/OMB)
Care partner (CP) · Unknown or Not Reported
|
0 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
0 Participants
n=7 Participants • The overall number includes both care recipients and care partners.
|
0 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
|
Race (NIH/OMB)
Care recipient (CR) · American Indian or Alaska Native
|
0 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
1 Participants
n=7 Participants • The overall number includes both care recipients and care partners.
|
1 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
|
Race (NIH/OMB)
Care recipient (CR) · Asian
|
0 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
0 Participants
n=7 Participants • The overall number includes both care recipients and care partners.
|
0 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
|
Race (NIH/OMB)
Care recipient (CR) · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
1 Participants
n=7 Participants • The overall number includes both care recipients and care partners.
|
1 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
|
Race (NIH/OMB)
Care recipient (CR) · Black or African American
|
7 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
3 Participants
n=7 Participants • The overall number includes both care recipients and care partners.
|
10 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
|
Race (NIH/OMB)
Care recipient (CR) · White
|
67 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
68 Participants
n=7 Participants • The overall number includes both care recipients and care partners.
|
135 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
|
Race (NIH/OMB)
Care recipient (CR) · More than one race
|
4 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
3 Participants
n=7 Participants • The overall number includes both care recipients and care partners.
|
7 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
|
Race (NIH/OMB)
Care recipient (CR) · Unknown or Not Reported
|
2 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
0 Participants
n=7 Participants • The overall number includes both care recipients and care partners.
|
2 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
|
Race (NIH/OMB)
Care partner (CP) · American Indian or Alaska Native
|
0 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
3 Participants
n=7 Participants • The overall number includes both care recipients and care partners.
|
3 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
|
Race (NIH/OMB)
Care partner (CP) · Asian
|
3 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
3 Participants
n=7 Participants • The overall number includes both care recipients and care partners.
|
6 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
|
Race (NIH/OMB)
Care partner (CP) · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
0 Participants
n=7 Participants • The overall number includes both care recipients and care partners.
|
0 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
|
Race (NIH/OMB)
Care partner (CP) · Black or African American
|
4 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
3 Participants
n=7 Participants • The overall number includes both care recipients and care partners.
|
7 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
|
Race (NIH/OMB)
Care partner (CP) · White
|
62 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
58 Participants
n=7 Participants • The overall number includes both care recipients and care partners.
|
120 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
|
Race (NIH/OMB)
Care partner (CP) · More than one race
|
10 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
6 Participants
n=7 Participants • The overall number includes both care recipients and care partners.
|
16 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
|
Race (NIH/OMB)
Care partner (CP) · Unknown or Not Reported
|
1 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
3 Participants
n=7 Participants • The overall number includes both care recipients and care partners.
|
4 Participants
n=5 Participants • The overall number includes both care recipients and care partners.
|
PRIMARY outcome
Timeframe: Baseline, 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.
Outcome measures
| Measure |
Personalized Intervention
n=80 Participants
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.
|
Standard Intervention
n=76 Participants
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.
|
|---|---|---|
|
Change in Physical Activity of Care Recipient
Baseline
|
3.20 days
Standard Deviation 2.56
|
2.76 days
Standard Deviation 2.53
|
|
Change in Physical Activity of Care Recipient
6 weeks
|
3.01 days
Standard Deviation 2.66
|
2.66 days
Standard Deviation 2.53
|
|
Change in Physical Activity of Care Recipient
13 weeks
|
3.81 days
Standard Deviation 2.40
|
3.79 days
Standard Deviation 2.54
|
|
Change in Physical Activity of Care Recipient
30 weeks
|
3.67 days
Standard Deviation 2.67
|
3.21 days
Standard Deviation 2.60
|
|
Change in Physical Activity of Care Recipient
13 months
|
2.96 days
Standard Deviation 2.51
|
2.96 days
Standard Deviation 2.51
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Personalized Intervention
n=80 Participants
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.
|
Standard Intervention
n=76 Participants
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.
|
|---|---|---|
|
Depression of Care Partner: Center for Epidemiological Studies-Depression Scale (CESD-10)
Baseline
|
7.38 score on a scale
Standard Deviation 5.45
|
6.98 score on a scale
Standard Deviation 5.57
|
|
Depression of Care Partner: Center for Epidemiological Studies-Depression Scale (CESD-10)
6 weeks
|
6.76 score on a scale
Standard Deviation 6.29
|
6.95 score on a scale
Standard Deviation 5.01
|
|
Depression of Care Partner: Center for Epidemiological Studies-Depression Scale (CESD-10)
13 weeks
|
5.63 score on a scale
Standard Deviation 5.58
|
6.38 score on a scale
Standard Deviation 5.22
|
|
Depression of Care Partner: Center for Epidemiological Studies-Depression Scale (CESD-10)
30 weeks
|
6.43 score on a scale
Standard Deviation 5.98
|
7.21 score on a scale
Standard Deviation 4.62
|
|
Depression of Care Partner: Center for Epidemiological Studies-Depression Scale (CESD-10)
13 months
|
5.23 score on a scale
Standard Deviation 5.58
|
5.70 score on a scale
Standard Deviation 6.22
|
SECONDARY outcome
Timeframe: Baseline, 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.
Outcome measures
| Measure |
Personalized Intervention
n=80 Participants
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.
|
Standard Intervention
n=76 Participants
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.
|
|---|---|---|
|
Quality of Life in Alzheimer's Disease, Care Recipient
Baseline
|
33.29 score on a scale
Standard Deviation 6.46
|
34.71 score on a scale
Standard Deviation 7.13
|
|
Quality of Life in Alzheimer's Disease, Care Recipient
6 weeks
|
33.94 score on a scale
Standard Deviation 5.98
|
34.07 score on a scale
Standard Deviation 7.05
|
|
Quality of Life in Alzheimer's Disease, Care Recipient
13 weeks
|
36.49 score on a scale
Standard Deviation 6.42
|
35.37 score on a scale
Standard Deviation 6.87
|
|
Quality of Life in Alzheimer's Disease, Care Recipient
30 weeks
|
35.46 score on a scale
Standard Deviation 6.12
|
34.79 score on a scale
Standard Deviation 6.80
|
|
Quality of Life in Alzheimer's Disease, Care Recipient
13 months
|
33.94 score on a scale
Standard Deviation 7.31
|
35.37 score on a scale
Standard Deviation 6.82
|
SECONDARY outcome
Timeframe: Baseline, 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.
Outcome measures
| Measure |
Personalized Intervention
n=80 Participants
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.
|
Standard Intervention
n=76 Participants
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.
|
|---|---|---|
|
Memory-Related Disturbance, Care Recipient
Baseline
|
1.24 score on a scale
Standard Deviation 0.78
|
1.19 score on a scale
Standard Deviation 0.72
|
|
Memory-Related Disturbance, Care Recipient
6 weeks
|
1.21 score on a scale
Standard Deviation 0.80
|
1.15 score on a scale
Standard Deviation 0.73
|
|
Memory-Related Disturbance, Care Recipient
13 weeks
|
1.10 score on a scale
Standard Deviation 0.80
|
1.10 score on a scale
Standard Deviation 0.76
|
|
Memory-Related Disturbance, Care Recipient
30 weeks
|
1.21 score on a scale
Standard Deviation 0.85
|
1.14 score on a scale
Standard Deviation 0.79
|
|
Memory-Related Disturbance, Care Recipient
13 months
|
1.29 score on a scale
Standard Deviation 0.93
|
1.14 score on a scale
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Personalized Intervention
n=80 Participants
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.
|
Standard Intervention
n=76 Participants
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.
|
|---|---|---|
|
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
|
58.46 score on a scale
Standard Deviation 31.04
|
|
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
|
59.16 score on a scale
Standard Deviation 30.19
|
|
Physical Functioning of Care Recipient: Medical Outcomes Study 36-Item Short Form (SF-36)
13 weeks
|
59.95 score on a scale
Standard Deviation 28.40
|
61.24 score on a scale
Standard Deviation 31.70
|
|
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
|
57.79 score on a scale
Standard Deviation 32.00
|
|
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
|
57.45 score on a scale
Standard Deviation 30.62
|
SECONDARY outcome
Timeframe: Baseline, 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.
Outcome measures
| Measure |
Personalized Intervention
n=80 Participants
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.
|
Standard Intervention
n=76 Participants
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.
|
|---|---|---|
|
Perceived Stress of Care Partner
Baseline
|
2.39 score on a scale
Standard Deviation 0.28
|
2.42 score on a scale
Standard Deviation 0.25
|
|
Perceived Stress of Care Partner
6 weeks
|
2.46 score on a scale
Standard Deviation 0.27
|
2.44 score on a scale
Standard Deviation 0.22
|
|
Perceived Stress of Care Partner
13 weeks
|
2.44 score on a scale
Standard Deviation 0.29
|
2.46 score on a scale
Standard Deviation 0.30
|
|
Perceived Stress of Care Partner
30 weeks
|
2.43 score on a scale
Standard Deviation 0.29
|
2.43 score on a scale
Standard Deviation 0.26
|
|
Perceived Stress of Care Partner
52 weeks
|
2.41 score on a scale
Standard Deviation 0.23
|
2.41 score on a scale
Standard Deviation 0.25
|
Adverse Events
Personalized Intervention, Care Recipient
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Personalized Intervention, Care Partner
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Intervention, Care Recipient
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths
Standard Intervention, Care Partner
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place