Trial Outcomes & Findings for Translating a Dementia Caregiver Intervention Into a Mobile Application (NCT NCT04330482)
NCT ID: NCT04330482
Last Updated: 2023-09-28
Results Overview
Percentage of participants who decline participation because of randomization.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
3 months
Results posted on
2023-09-28
Participant Flow
Participant milestones
| Measure |
Internet Links
A tablet pre-loaded with a list of internet links relating to dementia caregiving that participants will be instructed to use at least 4 times weekly for 3 months.
Internet Links: Participants randomized into this group will be instructed to use a computer tablet pre-loaded with a list of internet links relevant to dementia caregiving at least 4 times per week.
|
CARE-Well App
A tablet pre-loaded with the CARE-Well app that participants will be instructed to use at least 4 times weekly for 3 months.
CARE-Well App: Participants randomized into this group will be instructed to use the CARE-Well App at least 4 times per week.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
18
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
Internet Links
A tablet pre-loaded with a list of internet links relating to dementia caregiving that participants will be instructed to use at least 4 times weekly for 3 months.
Internet Links: Participants randomized into this group will be instructed to use a computer tablet pre-loaded with a list of internet links relevant to dementia caregiving at least 4 times per week.
|
CARE-Well App
A tablet pre-loaded with the CARE-Well app that participants will be instructed to use at least 4 times weekly for 3 months.
CARE-Well App: Participants randomized into this group will be instructed to use the CARE-Well App at least 4 times per week.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
Baseline Characteristics
Translating a Dementia Caregiver Intervention Into a Mobile Application
Baseline characteristics by cohort
| Measure |
Internet Links
n=20 Participants
A tablet pre-loaded with a list of internet links relating to dementia caregiving that participants will be instructed to use at least 4 times weekly for 3 months.
Internet Links: Participants randomized into this group will be instructed to use a computer tablet pre-loaded with a list of internet links relevant to dementia caregiving at least 4 times per week.
|
CARE-Well App
n=20 Participants
A tablet pre-loaded with the CARE-Well app that participants will be instructed to use at least 4 times weekly for 3 months.
CARE-Well App: Participants randomized into this group will be instructed to use the CARE-Well App at least 4 times per week.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Continuous
|
68.70 years
STANDARD_DEVIATION 8.15 • n=5 Participants
|
64.05 years
STANDARD_DEVIATION 12.43 • n=7 Participants
|
66.38 years
STANDARD_DEVIATION 10.64 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Depression
|
12.95 units on a scale
STANDARD_DEVIATION 8.02 • n=5 Participants
|
13.55 units on a scale
STANDARD_DEVIATION 9.69 • n=7 Participants
|
13.25 units on a scale
STANDARD_DEVIATION 9.69 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPercentage of participants who decline participation because of randomization.
Outcome measures
| Measure |
Internet Links
n=20 Participants
A tablet pre-loaded with a list of internet links relating to dementia caregiving that participants will be instructed to use at least 4 times weekly for 3 months.
Internet Links: Participants randomized into this group will be instructed to use a computer tablet pre-loaded with a list of internet links relevant to dementia caregiving at least 4 times per week.
|
CARE-Well App
n=20 Participants
A tablet pre-loaded with the CARE-Well app that participants will be instructed to use at least 4 times weekly for 3 months.
CARE-Well App: Participants randomized into this group will be instructed to use the CARE-Well App at least 4 times per week.
|
|---|---|---|
|
Randomization
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPercentage of participants enrolled and who remain enrolled for the duration of the study.
Outcome measures
| Measure |
Internet Links
n=20 Participants
A tablet pre-loaded with a list of internet links relating to dementia caregiving that participants will be instructed to use at least 4 times weekly for 3 months.
Internet Links: Participants randomized into this group will be instructed to use a computer tablet pre-loaded with a list of internet links relevant to dementia caregiving at least 4 times per week.
|
CARE-Well App
n=20 Participants
A tablet pre-loaded with the CARE-Well app that participants will be instructed to use at least 4 times weekly for 3 months.
CARE-Well App: Participants randomized into this group will be instructed to use the CARE-Well App at least 4 times per week.
|
|---|---|---|
|
Study Enrollment Rate and Retention
|
18 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPercentage of participants who used the internet links or the app for the 3-month intervention period.
Outcome measures
| Measure |
Internet Links
n=18 Participants
A tablet pre-loaded with a list of internet links relating to dementia caregiving that participants will be instructed to use at least 4 times weekly for 3 months.
Internet Links: Participants randomized into this group will be instructed to use a computer tablet pre-loaded with a list of internet links relevant to dementia caregiving at least 4 times per week.
|
CARE-Well App
n=16 Participants
A tablet pre-loaded with the CARE-Well app that participants will be instructed to use at least 4 times weekly for 3 months.
CARE-Well App: Participants randomized into this group will be instructed to use the CARE-Well App at least 4 times per week.
|
|---|---|---|
|
Intervention Adherence
|
18 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPercentage of participants who completed assessments at baseline and follow-up within two weeks of enrollment or completion of the study.
Outcome measures
| Measure |
Internet Links
n=18 Participants
A tablet pre-loaded with a list of internet links relating to dementia caregiving that participants will be instructed to use at least 4 times weekly for 3 months.
Internet Links: Participants randomized into this group will be instructed to use a computer tablet pre-loaded with a list of internet links relevant to dementia caregiving at least 4 times per week.
|
CARE-Well App
n=16 Participants
A tablet pre-loaded with the CARE-Well app that participants will be instructed to use at least 4 times weekly for 3 months.
CARE-Well App: Participants randomized into this group will be instructed to use the CARE-Well App at least 4 times per week.
|
|---|---|---|
|
Timing of Assessments
|
18 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPercentage of participants who completed the intervention.
Outcome measures
| Measure |
Internet Links
n=20 Participants
A tablet pre-loaded with a list of internet links relating to dementia caregiving that participants will be instructed to use at least 4 times weekly for 3 months.
Internet Links: Participants randomized into this group will be instructed to use a computer tablet pre-loaded with a list of internet links relevant to dementia caregiving at least 4 times per week.
|
CARE-Well App
n=20 Participants
A tablet pre-loaded with the CARE-Well app that participants will be instructed to use at least 4 times weekly for 3 months.
CARE-Well App: Participants randomized into this group will be instructed to use the CARE-Well App at least 4 times per week.
|
|---|---|---|
|
Completion Rates
|
18 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPercentage of participants in a subset of caregivers (10 from each group) interested in continuing to use tablet/App use after formal trial as an estimate of sustainability.
Outcome measures
| Measure |
Internet Links
n=10 Participants
A tablet pre-loaded with a list of internet links relating to dementia caregiving that participants will be instructed to use at least 4 times weekly for 3 months.
Internet Links: Participants randomized into this group will be instructed to use a computer tablet pre-loaded with a list of internet links relevant to dementia caregiving at least 4 times per week.
|
CARE-Well App
n=10 Participants
A tablet pre-loaded with the CARE-Well app that participants will be instructed to use at least 4 times weekly for 3 months.
CARE-Well App: Participants randomized into this group will be instructed to use the CARE-Well App at least 4 times per week.
|
|---|---|---|
|
Interest in Continuation of Tablet/App Use After Formal Trial
|
10 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPercentage of participants satisfied or very satisfied with App technology.
Outcome measures
| Measure |
Internet Links
n=18 Participants
A tablet pre-loaded with a list of internet links relating to dementia caregiving that participants will be instructed to use at least 4 times weekly for 3 months.
Internet Links: Participants randomized into this group will be instructed to use a computer tablet pre-loaded with a list of internet links relevant to dementia caregiving at least 4 times per week.
|
CARE-Well App
n=16 Participants
A tablet pre-loaded with the CARE-Well app that participants will be instructed to use at least 4 times weekly for 3 months.
CARE-Well App: Participants randomized into this group will be instructed to use the CARE-Well App at least 4 times per week.
|
|---|---|---|
|
App Technology Satisfaction
|
13 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPercentage of participants satisfied or very satisfied with App content.
Outcome measures
| Measure |
Internet Links
n=18 Participants
A tablet pre-loaded with a list of internet links relating to dementia caregiving that participants will be instructed to use at least 4 times weekly for 3 months.
Internet Links: Participants randomized into this group will be instructed to use a computer tablet pre-loaded with a list of internet links relevant to dementia caregiving at least 4 times per week.
|
CARE-Well App
n=16 Participants
A tablet pre-loaded with the CARE-Well app that participants will be instructed to use at least 4 times weekly for 3 months.
CARE-Well App: Participants randomized into this group will be instructed to use the CARE-Well App at least 4 times per week.
|
|---|---|---|
|
App Content Satisfaction
|
13 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Baseline and immediately Post-Intervention at 3 monthsDepression scale; 0-30 points; higher scores indicate worse outcome.
Outcome measures
| Measure |
Internet Links
n=18 Participants
A tablet pre-loaded with a list of internet links relating to dementia caregiving that participants will be instructed to use at least 4 times weekly for 3 months.
Internet Links: Participants randomized into this group will be instructed to use a computer tablet pre-loaded with a list of internet links relevant to dementia caregiving at least 4 times per week.
|
CARE-Well App
n=16 Participants
A tablet pre-loaded with the CARE-Well app that participants will be instructed to use at least 4 times weekly for 3 months.
CARE-Well App: Participants randomized into this group will be instructed to use the CARE-Well App at least 4 times per week.
|
|---|---|---|
|
Center for Epidemiologic Studies Depression Scale
Baseline
|
13.29 units on a scale
Standard Deviation 7.88
|
13.94 units on a scale
Standard Deviation 12.19
|
|
Center for Epidemiologic Studies Depression Scale
Post-Intervention
|
16.71 units on a scale
Standard Deviation 8.36
|
17.38 units on a scale
Standard Deviation 11.67
|
SECONDARY outcome
Timeframe: Baseline and immediately Post-Intervention at 3 monthsCaregiver burden scale; 0-88 points; higher scores indicate worse outcome.
Outcome measures
| Measure |
Internet Links
n=18 Participants
A tablet pre-loaded with a list of internet links relating to dementia caregiving that participants will be instructed to use at least 4 times weekly for 3 months.
Internet Links: Participants randomized into this group will be instructed to use a computer tablet pre-loaded with a list of internet links relevant to dementia caregiving at least 4 times per week.
|
CARE-Well App
n=16 Participants
A tablet pre-loaded with the CARE-Well app that participants will be instructed to use at least 4 times weekly for 3 months.
CARE-Well App: Participants randomized into this group will be instructed to use the CARE-Well App at least 4 times per week.
|
|---|---|---|
|
Zarit Burden Interview
Baseline
|
55.53 units on a scale
Standard Deviation 9.82
|
56.56 units on a scale
Standard Deviation 14.40
|
|
Zarit Burden Interview
Post Intervention
|
58.11 units on a scale
Standard Deviation 10.93
|
57.56 units on a scale
Standard Deviation 13.22
|
SECONDARY outcome
Timeframe: Baseline and immediately Post-Intervention at 3 monthsCaregiver reaction to problem behaviors; range 0-96 Higher scores indicate worse outcomes.
Outcome measures
| Measure |
Internet Links
n=18 Participants
A tablet pre-loaded with a list of internet links relating to dementia caregiving that participants will be instructed to use at least 4 times weekly for 3 months.
Internet Links: Participants randomized into this group will be instructed to use a computer tablet pre-loaded with a list of internet links relevant to dementia caregiving at least 4 times per week.
|
CARE-Well App
n=16 Participants
A tablet pre-loaded with the CARE-Well app that participants will be instructed to use at least 4 times weekly for 3 months.
CARE-Well App: Participants randomized into this group will be instructed to use the CARE-Well App at least 4 times per week.
|
|---|---|---|
|
Revised Memory and Behavior Problem Checklist
Baseline
|
22.88 units on a scale
Standard Deviation 7.90
|
22.00 units on a scale
Standard Deviation 8.61
|
|
Revised Memory and Behavior Problem Checklist
Post Intervention
|
18.10 units on a scale
Standard Deviation 10.56
|
11.56 units on a scale
Standard Deviation 16.91
|
SECONDARY outcome
Timeframe: Baseline and immediately Post-Intervention at 3 monthsCaregiver desire to institutionalize care recipient; 0-7 points; high scores indicate worse outcome (or stronger desire to institutionalize).
Outcome measures
| Measure |
Internet Links
n=18 Participants
A tablet pre-loaded with a list of internet links relating to dementia caregiving that participants will be instructed to use at least 4 times weekly for 3 months.
Internet Links: Participants randomized into this group will be instructed to use a computer tablet pre-loaded with a list of internet links relevant to dementia caregiving at least 4 times per week.
|
CARE-Well App
n=16 Participants
A tablet pre-loaded with the CARE-Well app that participants will be instructed to use at least 4 times weekly for 3 months.
CARE-Well App: Participants randomized into this group will be instructed to use the CARE-Well App at least 4 times per week.
|
|---|---|---|
|
Desire to Institutionalize Scale
Baseline
|
0.82 units on a scale
Standard Deviation 1.24
|
1.38 units on a scale
Standard Deviation 1.45
|
|
Desire to Institutionalize Scale
Post Intervention
|
1.12 units on a scale
Standard Deviation 1.54
|
1.94 units on a scale
Standard Deviation 2.29
|
Adverse Events
Internet Links
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CARE-Well App
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