Trial Outcomes & Findings for CommunityRx-Dementia (NCT NCT04146545)
NCT ID: NCT04146545
Last Updated: 2025-04-03
Results Overview
Self-efficacy is measured with a 4-item sub-domain from the 2015 Caregiver Dementia Care and Self-Efficacy Survey (Jennings et al). Responses to each of the items are scored between 1 = "strongly disagree" to 5 = "strongly agree" and will generate an average score. Higher values = greater self-efficacy
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
360 participants
Primary outcome timeframe
12 months
Results posted on
2025-04-03
Participant Flow
Participant milestones
| Measure |
Cases
Community Rx-Dementia "CRxD" Caregiver Resources
Community Rx-Dementia "CRxD" Caregiver Resources: A tailored list of resources addressing health-related social needs (HRSN) for caregivers and access to an online community resource finder.
|
Control
Usual Standard Care
|
|---|---|---|
|
Overall Study
STARTED
|
178
|
182
|
|
Overall Study
Main Randomized Trial
|
171
|
173
|
|
Overall Study
Supplement
|
7
|
9
|
|
Overall Study
COMPLETED
|
177
|
182
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Cases
Community Rx-Dementia "CRxD" Caregiver Resources
Community Rx-Dementia "CRxD" Caregiver Resources: A tailored list of resources addressing health-related social needs (HRSN) for caregivers and access to an online community resource finder.
|
Control
Usual Standard Care
|
|---|---|---|
|
Overall Study
deemed ineligible after randomization
|
1
|
0
|
Baseline Characteristics
Number analyzed differs from overall due to missing data
Baseline characteristics by cohort
| Measure |
Cases - Main Randomized Trial
n=170 Participants
Community Rx-Dementia "CRxD" Caregiver Resources, Enrolled as part of the Main Randomized Trial
Community Rx-Dementia "CRxD" Caregiver Resources: A tailored list of resources addressing health-related social needs (HRSN) for caregivers and access to an online community resource finder.
|
Control - Main Randomized Trial
n=173 Participants
Usual Standard Care - Enrolled as part of the Main Randomized Trial
|
Cases - Supplement
n=7 Participants
Community Rx-Dementia "CRxD" Caregiver Resources, Enrolled as part of the Supplement
Community Rx-Dementia "CRxD" Caregiver Resources: A tailored list of resources addressing health-related social needs (HRSN) for caregivers and access to an online community resource finder.
|
Control - Supplement
n=9 Participants
Usual Standard Care - Enrolled as part of the Supplement
|
Total
n=359 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
59.9 years
STANDARD_DEVIATION 11.8 • n=170 Participants
|
59.0 years
STANDARD_DEVIATION 12.0 • n=173 Participants
|
58.7 years
STANDARD_DEVIATION 15.3 • n=7 Participants
|
58.6 years
STANDARD_DEVIATION 13.5 • n=9 Participants
|
59.4 years
STANDARD_DEVIATION 12.0 • n=359 Participants
|
|
Sex: Female, Male
Female
|
133 Participants
n=169 Participants • Number analyzed differs from overall due to missing data
|
135 Participants
n=173 Participants • Number analyzed differs from overall due to missing data
|
0 Participants
n=7 Participants • Number analyzed differs from overall due to missing data
|
0 Participants
n=9 Participants • Number analyzed differs from overall due to missing data
|
268 Participants
n=358 Participants • Number analyzed differs from overall due to missing data
|
|
Sex: Female, Male
Male
|
36 Participants
n=169 Participants • Number analyzed differs from overall due to missing data
|
38 Participants
n=173 Participants • Number analyzed differs from overall due to missing data
|
7 Participants
n=7 Participants • Number analyzed differs from overall due to missing data
|
9 Participants
n=9 Participants • Number analyzed differs from overall due to missing data
|
90 Participants
n=358 Participants • Number analyzed differs from overall due to missing data
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
142 Participants
n=170 Participants • Number analyzed differs from overall due to missing data
|
132 Participants
n=170 Participants • Number analyzed differs from overall due to missing data
|
7 Participants
n=7 Participants • Number analyzed differs from overall due to missing data
|
5 Participants
n=9 Participants • Number analyzed differs from overall due to missing data
|
286 Participants
n=356 Participants • Number analyzed differs from overall due to missing data
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
11 Participants
n=170 Participants • Number analyzed differs from overall due to missing data
|
16 Participants
n=170 Participants • Number analyzed differs from overall due to missing data
|
0 Participants
n=7 Participants • Number analyzed differs from overall due to missing data
|
3 Participants
n=9 Participants • Number analyzed differs from overall due to missing data
|
30 Participants
n=356 Participants • Number analyzed differs from overall due to missing data
|
|
Race/Ethnicity, Customized
Hispanic
|
7 Participants
n=170 Participants • Number analyzed differs from overall due to missing data
|
7 Participants
n=170 Participants • Number analyzed differs from overall due to missing data
|
0 Participants
n=7 Participants • Number analyzed differs from overall due to missing data
|
1 Participants
n=9 Participants • Number analyzed differs from overall due to missing data
|
15 Participants
n=356 Participants • Number analyzed differs from overall due to missing data
|
|
Race/Ethnicity, Customized
Other
|
10 Participants
n=170 Participants • Number analyzed differs from overall due to missing data
|
15 Participants
n=170 Participants • Number analyzed differs from overall due to missing data
|
0 Participants
n=7 Participants • Number analyzed differs from overall due to missing data
|
0 Participants
n=9 Participants • Number analyzed differs from overall due to missing data
|
25 Participants
n=356 Participants • Number analyzed differs from overall due to missing data
|
|
Region of Enrollment
United States
|
170 participants
n=170 Participants
|
173 participants
n=173 Participants
|
7 participants
n=7 Participants
|
9 participants
n=9 Participants
|
359 participants
n=359 Participants
|
|
Presence of at least 1 health-related social risk factor
None
|
106 Participants
n=170 Participants
|
104 Participants
n=173 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=9 Participants
|
219 Participants
n=359 Participants
|
|
Presence of at least 1 health-related social risk factor
One or more
|
64 Participants
n=170 Participants
|
69 Participants
n=173 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=9 Participants
|
140 Participants
n=359 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Analysis was restricted to caregivers in the main randomized trial who had at least 1 unmet health-related social need at baseline and completed the self-efficacy measure at 12 month follow-up
Self-efficacy is measured with a 4-item sub-domain from the 2015 Caregiver Dementia Care and Self-Efficacy Survey (Jennings et al). Responses to each of the items are scored between 1 = "strongly disagree" to 5 = "strongly agree" and will generate an average score. Higher values = greater self-efficacy
Outcome measures
| Measure |
Cases
n=39 Participants
Community Rx-Dementia "CRxD" Caregiver Resources
Community Rx-Dementia "CRxD" Caregiver Resources: A tailored list of resources addressing health-related social needs (HRSN) for caregivers and access to an online community resource finder.
|
Control
n=36 Participants
Usual Standard Care
|
|---|---|---|
|
Caregiver Self-efficacy at 12 Months Among Caregivers With Unmet Health Related Social Needs
|
3.5 score on a scale
Standard Deviation 0.7
|
3.5 score on a scale
Standard Deviation 1.0
|
PRIMARY outcome
Timeframe: 7 daysPopulation: Analysis was restricted to caregivers in the main randomized trial who completed the satisfaction measure at 1 week follow-up
Satisfaction will be assessed using the Patient Satisfaction Questionnaire 18-item short form (PSQ-18), specifically the general satisfaction sub-scale (2 questions). Five possible response options for each of the two items are scored 1 to 5; with a higher score equating to higher satisfaction. Scores will be transformed using the formula: y= 100 \* (x-a)/(b-a) where y=the transformed score, x=the original score, a=the minimum possible score and b=the maximum possible score. Transformed items will be averaged to generate the composite score (range 0-100; higher scores indicating greater satisfaction).
Outcome measures
| Measure |
Cases
n=160 Participants
Community Rx-Dementia "CRxD" Caregiver Resources
Community Rx-Dementia "CRxD" Caregiver Resources: A tailored list of resources addressing health-related social needs (HRSN) for caregivers and access to an online community resource finder.
|
Control
n=156 Participants
Usual Standard Care
|
|---|---|---|
|
Satisfaction With Care
|
71.4 score on a scale
Standard Deviation 19.3
|
69.6 score on a scale
Standard Deviation 21.8
|
Adverse Events
Cases
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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