Trial Outcomes & Findings for Caring for the Caregiver Network (NCT NCT03049501)
NCT ID: NCT03049501
Last Updated: 2019-06-25
Results Overview
CES-D Scale ranges from 0 to 30 with higher scores indicating greater frequency of depressive symptoms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
244 participants
Primary outcome timeframe
Baseline, 6-mth follow-up and 12-mth follow-up
Results posted on
2019-06-25
Participant Flow
Participant milestones
| Measure |
Caregiving Condition
Participants will receive a computer tablet and have access to web-based skill building sessions, videos from experts, annotated resources and information and tips on caregiving-related topics
Caregiving condition
|
Nutrition Condition
Participants will receive a computer tablet and have access to web-based training sessions on different topics related to nutrition
Nutrition condition
|
|---|---|---|
|
Overall Study
STARTED
|
123
|
121
|
|
Overall Study
6 Month Follow up
|
107
|
91
|
|
Overall Study
12 Month Follow up
|
101
|
92
|
|
Overall Study
COMPLETED
|
101
|
92
|
|
Overall Study
NOT COMPLETED
|
22
|
29
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Caring for the Caregiver Network
Baseline characteristics by cohort
| Measure |
Caregiving Condition
n=123 Participants
Participants will receive a computer tablet and have access to web-based skill building sessions, videos from experts, annotated resources and information and tips on caregiving-related topics
Caregiving condition
|
Nutrition Condition
n=121 Participants
Participants will receive a computer tablet and have access to web-based training sessions on different topics related to nutrition
Nutrition condition
|
Total
n=244 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
|
68 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
55 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
204 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
55 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
68 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
135 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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
29 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
85 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
174 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
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6-mth follow-up and 12-mth follow-upPopulation: Follow up visits were not completed for all participants
CES-D Scale ranges from 0 to 30 with higher scores indicating greater frequency of depressive symptoms.
Outcome measures
| Measure |
Caregiving Condition
n=123 Participants
Participants will receive a computer tablet and have access to web-based skill building sessions, videos from experts, annotated resources and information and tips on caregiving-related topics
Caregiving condition
|
Nutrition Condition
n=121 Participants
Participants will receive a computer tablet and have access to web-based training sessions on different topics related to nutrition
Nutrition condition
|
|---|---|---|
|
Depression as Measured by Center for Epidemiologic Studies Depression Scale (CES-D)
Baseline
|
11.38 score on a scale
Standard Deviation 7.02
|
10.88 score on a scale
Standard Deviation 5.79
|
|
Depression as Measured by Center for Epidemiologic Studies Depression Scale (CES-D)
12 month follow up
|
10.32 score on a scale
Standard Deviation 7.18
|
10.46 score on a scale
Standard Deviation 6.25
|
|
Depression as Measured by Center for Epidemiologic Studies Depression Scale (CES-D)
6 month follow up
|
10.86 score on a scale
Standard Deviation 6.63
|
10.69 score on a scale
Standard Deviation 6.23
|
PRIMARY outcome
Timeframe: Baseline, 6-mth follow-up and 12-mth follow-upPopulation: Follow up visits were not completed for all participants
Higher score means greater level of caregiver burden. Range (0-44)
Outcome measures
| Measure |
Caregiving Condition
n=123 Participants
Participants will receive a computer tablet and have access to web-based skill building sessions, videos from experts, annotated resources and information and tips on caregiving-related topics
Caregiving condition
|
Nutrition Condition
n=121 Participants
Participants will receive a computer tablet and have access to web-based training sessions on different topics related to nutrition
Nutrition condition
|
|---|---|---|
|
Caregiving Burden as Measured by Burden Inventory
Baseline
|
18.52 score on a scale
Standard Deviation 8.91
|
19.66 score on a scale
Standard Deviation 7.59
|
|
Caregiving Burden as Measured by Burden Inventory
6 month follow up
|
16.89 score on a scale
Standard Deviation 8.39
|
18.23 score on a scale
Standard Deviation 6.97
|
|
Caregiving Burden as Measured by Burden Inventory
12 month follow up
|
16.08 score on a scale
Standard Deviation 8.29
|
17.66 score on a scale
Standard Deviation 8.27
|
PRIMARY outcome
Timeframe: Baseline, 6-mth follow-up and 12-mth follow-upPopulation: Follow up visits were not completed for all participants
A 13 Item self care questionnaire is used to measure caregivers self care. Each item can be scored as 0,1,negative 3 or negative 4. The total score ranging from negative 52 to 13. Higher score means better in keeping medical obligations to him/herself.
Outcome measures
| Measure |
Caregiving Condition
n=123 Participants
Participants will receive a computer tablet and have access to web-based skill building sessions, videos from experts, annotated resources and information and tips on caregiving-related topics
Caregiving condition
|
Nutrition Condition
n=121 Participants
Participants will receive a computer tablet and have access to web-based training sessions on different topics related to nutrition
Nutrition condition
|
|---|---|---|
|
Caregiver's Self Report of Self-care
Baseline
|
0.62 score on a scale
Standard Deviation 0.18
|
0.60 score on a scale
Standard Deviation 0.17
|
|
Caregiver's Self Report of Self-care
6 month follow up
|
0.62 score on a scale
Standard Deviation 0.18
|
0.60 score on a scale
Standard Deviation 0.17
|
|
Caregiver's Self Report of Self-care
12 month follow up
|
0.62 score on a scale
Standard Deviation 0.20
|
0.61 score on a scale
Standard Deviation 0.17
|
PRIMARY outcome
Timeframe: Baseline, 6-mth follow-up and 12-mth follow-upPopulation: Follow up visits were not completed for all participants
SF 12 Health Survey was used to measure physical health of the caregiver. Scores ranges from 0 to 35 with lower score means less limitation to physical health.
Outcome measures
| Measure |
Caregiving Condition
n=123 Participants
Participants will receive a computer tablet and have access to web-based skill building sessions, videos from experts, annotated resources and information and tips on caregiving-related topics
Caregiving condition
|
Nutrition Condition
n=121 Participants
Participants will receive a computer tablet and have access to web-based training sessions on different topics related to nutrition
Nutrition condition
|
|---|---|---|
|
Caregiver's Self-report of Physical Health
Baseline
|
2.71 score on a scale
Standard Deviation 1.03
|
2.75 score on a scale
Standard Deviation 1.14
|
|
Caregiver's Self-report of Physical Health
6 month follow up
|
2.89 score on a scale
Standard Deviation 1.12
|
2.51 score on a scale
Standard Deviation 1.11
|
|
Caregiver's Self-report of Physical Health
12 month follow up
|
2.76 score on a scale
Standard Deviation 1.09
|
2.67 score on a scale
Standard Deviation 1.22
|
PRIMARY outcome
Timeframe: Baseline, 6-mth follow-up and 12-mth follow-upPopulation: Follow up visits were not completed for all participants
A 15 item Caregiver's self efficacy questionnaire will be used to assess caregiver's self-efficacy. The questionnaire score ranges from 0-1500 percent with a lower percentage score indicating less efficacy.
Outcome measures
| Measure |
Caregiving Condition
n=123 Participants
Participants will receive a computer tablet and have access to web-based skill building sessions, videos from experts, annotated resources and information and tips on caregiving-related topics
Caregiving condition
|
Nutrition Condition
n=121 Participants
Participants will receive a computer tablet and have access to web-based training sessions on different topics related to nutrition
Nutrition condition
|
|---|---|---|
|
Caregiver's Self-efficacy
Baseline
|
925.21 percentage of efficacy
Standard Deviation 243.36
|
936.65 percentage of efficacy
Standard Deviation 249.62
|
|
Caregiver's Self-efficacy
6 month follow up
|
971.43 percentage of efficacy
Standard Deviation 295.41
|
964.15 percentage of efficacy
Standard Deviation 273.06
|
|
Caregiver's Self-efficacy
12 month follow up
|
999.65 percentage of efficacy
Standard Deviation 285.94
|
1047.71 percentage of efficacy
Standard Deviation 225.14
|
PRIMARY outcome
Timeframe: Baseline, 6-mth follow-up and 12-mth follow-upPopulation: Follow up visits were not completed for all participants
An 11 item positive aspects of caregiving questionnaire was used to measure positive aspects of caregiving. Each item can be scored 0, 1, 2, 3, 4, negative 3 or negative 4. The total score ranging from negative 44 to 44. Higher score means more positive feelings towards caregiving.
Outcome measures
| Measure |
Caregiving Condition
n=123 Participants
Participants will receive a computer tablet and have access to web-based skill building sessions, videos from experts, annotated resources and information and tips on caregiving-related topics
Caregiving condition
|
Nutrition Condition
n=121 Participants
Participants will receive a computer tablet and have access to web-based training sessions on different topics related to nutrition
Nutrition condition
|
|---|---|---|
|
Positive Aspects of Caregiving
Baseline
|
24.46 score on a scale
Standard Deviation 8.49
|
23.24 score on a scale
Standard Deviation 8.83
|
|
Positive Aspects of Caregiving
6 month follow up
|
24.72 score on a scale
Standard Deviation 8.34
|
24.02 score on a scale
Standard Deviation 8.54
|
|
Positive Aspects of Caregiving
12 month follow up
|
24.00 score on a scale
Standard Deviation 9.60
|
24.58 score on a scale
Standard Deviation 8.54
|
Adverse Events
Caregiving Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nutrition Condition
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