Trial Outcomes & Findings for Caregiving During Crisis (NCT NCT04939714)
NCT ID: NCT04939714
Last Updated: 2024-04-04
Results Overview
The CES-D is a 20-item self-report instrument asking respondents if they have experienced symptoms of depression during the past week. Responses are given on a scale of 0 to 3 where rarely is scored as 0 and most of the time is scored as 3. Total scores range from 0 to 60 and higher scores indicate greater symptoms of depression.
COMPLETED
NA
100 participants
Baseline, Week 8
2024-04-04
Participant Flow
Participant milestones
| Measure |
Psychoeducational Intervention Immediately
Caregivers receiving the psychoeducational intervention immediately.
|
Psychoeducational Intervention After Waiting Period
Caregivers receiving the psychoeducational intervention after a waiting period of 8 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
Completed Week 8 Assessment
|
38
|
38
|
|
Overall Study
COMPLETED
|
33
|
30
|
|
Overall Study
NOT COMPLETED
|
17
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age is missing for one caregiver
Baseline characteristics by cohort
| Measure |
Psychoeducational Intervention Immediately
n=50 Participants
Caregivers receiving the psychoeducational intervention immediately.
|
Psychoeducational Intervention After Waiting Period
n=50 Participants
Caregivers receiving the psychoeducational intervention after a waiting period of 8 weeks.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.245 years
STANDARD_DEVIATION 8.971 • n=49 Participants • Age is missing for one caregiver
|
63.800 years
STANDARD_DEVIATION 11.772 • n=50 Participants • Age is missing for one caregiver
|
64.515 years
STANDARD_DEVIATION 10.451 • n=99 Participants • Age is missing for one caregiver
|
|
Sex/Gender, Customized
Female
|
42 Participants
n=50 Participants
|
40 Participants
n=50 Participants
|
82 Participants
n=100 Participants
|
|
Sex/Gender, Customized
Male
|
6 Participants
n=50 Participants
|
10 Participants
n=50 Participants
|
16 Participants
n=100 Participants
|
|
Sex/Gender, Customized
Missing response
|
2 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
2 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=50 Participants
|
4 Participants
n=50 Participants
|
5 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=50 Participants
|
45 Participants
n=50 Participants
|
93 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=50 Participants
|
1 Participants
n=50 Participants
|
2 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
White
|
40 Participants
n=50 Participants
|
40 Participants
n=50 Participants
|
80 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
African American/Black
|
8 Participants
n=50 Participants
|
7 Participants
n=50 Participants
|
15 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=50 Participants
|
1 Participants
n=50 Participants
|
2 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=50 Participants
|
1 Participants
n=50 Participants
|
1 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
Missing response/did not wish to answer
|
1 Participants
n=50 Participants
|
1 Participants
n=50 Participants
|
2 Participants
n=100 Participants
|
|
Region of Enrollment
United States
|
50 Participants
n=50 Participants
|
50 Participants
n=50 Participants
|
100 Participants
n=100 Participants
|
|
Highest Education Level
High school/General Educational Development (GED) certificate
|
1 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=100 Participants
|
|
Highest Education Level
Some college
|
13 Participants
n=50 Participants
|
8 Participants
n=50 Participants
|
21 Participants
n=100 Participants
|
|
Highest Education Level
College graduate
|
14 Participants
n=50 Participants
|
16 Participants
n=50 Participants
|
30 Participants
n=100 Participants
|
|
Highest Education Level
Graduate degree
|
21 Participants
n=50 Participants
|
26 Participants
n=50 Participants
|
47 Participants
n=100 Participants
|
|
Highest Education Level
Missing response
|
1 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=100 Participants
|
|
Employed Outside of the Home
No
|
33 Participants
n=50 Participants
|
35 Participants
n=50 Participants
|
68 Participants
n=100 Participants
|
|
Employed Outside of the Home
Yes
|
16 Participants
n=50 Participants
|
15 Participants
n=50 Participants
|
31 Participants
n=100 Participants
|
|
Employed Outside of the Home
Missing response
|
1 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=100 Participants
|
|
Sexual Orientation
Bisexual
|
0 Participants
n=50 Participants
|
1 Participants
n=50 Participants
|
1 Participants
n=100 Participants
|
|
Sexual Orientation
Gay
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=100 Participants
|
|
Sexual Orientation
Lesbian
|
1 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=100 Participants
|
|
Sexual Orientation
Heterosexual
|
22 Participants
n=50 Participants
|
23 Participants
n=50 Participants
|
45 Participants
n=100 Participants
|
|
Sexual Orientation
Missing response
|
27 Participants
n=50 Participants
|
26 Participants
n=50 Participants
|
53 Participants
n=100 Participants
|
|
Geographic Area of Residence
Urban
|
17 Participants
n=50 Participants
|
15 Participants
n=50 Participants
|
32 Participants
n=100 Participants
|
|
Geographic Area of Residence
Suburban
|
22 Participants
n=50 Participants
|
30 Participants
n=50 Participants
|
52 Participants
n=100 Participants
|
|
Geographic Area of Residence
Rural
|
10 Participants
n=50 Participants
|
5 Participants
n=50 Participants
|
15 Participants
n=100 Participants
|
|
Geographic Area of Residence
Missing response
|
1 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=100 Participants
|
|
Care Provided for Spouse
No
|
25 Participants
n=50 Participants
|
27 Participants
n=50 Participants
|
52 Participants
n=100 Participants
|
|
Care Provided for Spouse
Yes
|
25 Participants
n=50 Participants
|
23 Participants
n=50 Participants
|
48 Participants
n=100 Participants
|
|
Age of Person Cared For
|
77.939 years
STANDARD_DEVIATION 9.286 • n=49 Participants • Age is missing for one person receiving care
|
78.560 years
STANDARD_DEVIATION 7.077 • n=50 Participants • Age is missing for one person receiving care
|
78.253 years
STANDARD_DEVIATION 8.208 • n=99 Participants • Age is missing for one person receiving care
|
|
Reside in Same House as Person Receiving Care
No
|
9 Participants
n=50 Participants
|
12 Participants
n=50 Participants
|
21 Participants
n=100 Participants
|
|
Reside in Same House as Person Receiving Care
Yes
|
40 Participants
n=50 Participants
|
38 Participants
n=50 Participants
|
78 Participants
n=100 Participants
|
|
Reside in Same House as Person Receiving Care
Missing response
|
1 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=100 Participants
|
|
Person Cared for Diagnosed with Dementia
No
|
5 Participants
n=50 Participants
|
3 Participants
n=50 Participants
|
8 Participants
n=100 Participants
|
|
Person Cared for Diagnosed with Dementia
Yes
|
44 Participants
n=50 Participants
|
47 Participants
n=50 Participants
|
91 Participants
n=100 Participants
|
|
Person Cared for Diagnosed with Dementia
Missing response
|
1 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=100 Participants
|
|
Stage of Dementia of Person Cared For
Early Stage - A person may function independently but is having memory lapses
|
5 Participants
n=50 Participants
|
5 Participants
n=50 Participants
|
10 Participants
n=100 Participants
|
|
Stage of Dementia of Person Cared For
Middle Stage - greater difficulty performing tasks but still remembers significant life details
|
32 Participants
n=50 Participants
|
33 Participants
n=50 Participants
|
65 Participants
n=100 Participants
|
|
Stage of Dementia of Person Cared For
Late Stage - loses ability to respond with environment/needs extensive help with daily activities
|
7 Participants
n=50 Participants
|
9 Participants
n=50 Participants
|
16 Participants
n=100 Participants
|
|
Stage of Dementia of Person Cared For
No known diagnosis of dementia
|
6 Participants
n=50 Participants
|
3 Participants
n=50 Participants
|
9 Participants
n=100 Participants
|
|
Amount of Help From Friends and Family
A great deal of help
|
8 Participants
n=50 Participants
|
11 Participants
n=50 Participants
|
19 Participants
n=100 Participants
|
|
Amount of Help From Friends and Family
Some help
|
9 Participants
n=50 Participants
|
10 Participants
n=50 Participants
|
19 Participants
n=100 Participants
|
|
Amount of Help From Friends and Family
A little help
|
6 Participants
n=50 Participants
|
10 Participants
n=50 Participants
|
16 Participants
n=100 Participants
|
|
Amount of Help From Friends and Family
Not much help
|
2 Participants
n=50 Participants
|
2 Participants
n=50 Participants
|
4 Participants
n=100 Participants
|
|
Amount of Help From Friends and Family
Almost no help
|
0 Participants
n=50 Participants
|
1 Participants
n=50 Participants
|
1 Participants
n=100 Participants
|
|
Amount of Help From Friends and Family
Missing response
|
25 Participants
n=50 Participants
|
16 Participants
n=50 Participants
|
41 Participants
n=100 Participants
|
|
Amount of Strife
They have only been helpful
|
16 Participants
n=50 Participants
|
12 Participants
n=50 Participants
|
28 Participants
n=100 Participants
|
|
Amount of Strife
Hardly any problems
|
16 Participants
n=50 Participants
|
21 Participants
n=50 Participants
|
37 Participants
n=100 Participants
|
|
Amount of Strife
Occasional Strife
|
11 Participants
n=50 Participants
|
11 Participants
n=50 Participants
|
22 Participants
n=100 Participants
|
|
Amount of Strife
Some serious difficulties
|
6 Participants
n=50 Participants
|
2 Participants
n=50 Participants
|
8 Participants
n=100 Participants
|
|
Amount of Strife
A main source of difficulties
|
0 Participants
n=50 Participants
|
4 Participants
n=50 Participants
|
4 Participants
n=100 Participants
|
|
Amount of Strife
Missing response
|
1 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=100 Participants
|
|
Also Provide Care to Others
No
|
25 Participants
n=50 Participants
|
28 Participants
n=50 Participants
|
53 Participants
n=100 Participants
|
|
Also Provide Care to Others
Yes
|
24 Participants
n=50 Participants
|
22 Participants
n=50 Participants
|
46 Participants
n=100 Participants
|
|
Also Provide Care to Others
Missing response
|
1 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=100 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: This analysis includes participants who attended the indicated study visits.
The CES-D is a 20-item self-report instrument asking respondents if they have experienced symptoms of depression during the past week. Responses are given on a scale of 0 to 3 where rarely is scored as 0 and most of the time is scored as 3. Total scores range from 0 to 60 and higher scores indicate greater symptoms of depression.
Outcome measures
| Measure |
Psychoeducational Intervention
n=50 Participants
Caregivers receiving the psychoeducational intervention immediately.
|
Waitlist Control Group
n=50 Participants
Caregivers on a waitlist to receive the psychoeducational intervention after a waiting period of 8 weeks.
|
|---|---|---|
|
Center for Epidemiologic Studies - Depression (CES-D) Scale Score
Baseline
|
11.7 score on a scale
Standard Deviation 8.8
|
11.8 score on a scale
Standard Deviation 8.0
|
|
Center for Epidemiologic Studies - Depression (CES-D) Scale Score
Week 8
|
10.4 score on a scale
Standard Deviation 8.7
|
14.6 score on a scale
Standard Deviation 9.6
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: This analysis includes participants who attended the indicated study visits and who provided complete information for the survey.
The STAI is a 20-item self-report scale of positive and negative anxiety experiences. Responses are given on a 4-point scale where 1 = not at all and 4 = very much so. Total scores range from 20 to 80 and higher scores indicate greater anxiety.
Outcome measures
| Measure |
Psychoeducational Intervention
n=50 Participants
Caregivers receiving the psychoeducational intervention immediately.
|
Waitlist Control Group
n=50 Participants
Caregivers on a waitlist to receive the psychoeducational intervention after a waiting period of 8 weeks.
|
|---|---|---|
|
State-Trait Anxiety Inventory (STAI) Score
Baseline
|
29.7 score on a scale
Standard Deviation 8.5
|
33.7 score on a scale
Standard Deviation 9.1
|
|
State-Trait Anxiety Inventory (STAI) Score
Week 8
|
32.6 score on a scale
Standard Deviation 10.4
|
38.2 score on a scale
Standard Deviation 12.5
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: This analysis includes participants who attended the indicated study visits.
The Perceived Stress Scale includes 14 items assessing self-reported caregiving stress. Responses are given on a 5-point scale where 0 = never and 4 = very often. Total scores range from 0 to 56 and higher values indicate greater perceived stress.
Outcome measures
| Measure |
Psychoeducational Intervention
n=50 Participants
Caregivers receiving the psychoeducational intervention immediately.
|
Waitlist Control Group
n=50 Participants
Caregivers on a waitlist to receive the psychoeducational intervention after a waiting period of 8 weeks.
|
|---|---|---|
|
Perceived Stress Scale (PSS-14) Score
Baseline
|
22.3 score on a scale
Standard Deviation 7.9
|
22.4 score on a scale
Standard Deviation 7.3
|
|
Perceived Stress Scale (PSS-14) Score
Week 8
|
21.7 score on a scale
Standard Deviation 7.1
|
23.1 score on a scale
Standard Deviation 8.1
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: This analysis includes participants who attended the indicated study visits and who provided complete information for the survey.
The RMBPC is a 24-item scale reporting on frequency of disturbing care recipient behaviors and severity or caregiver reactions to these behaviors. Respondents indicate how frequently problems have occurred on a 5-point scale where 0 = never occurred and 4 = daily or more often. Total frequency scores range from 0 to 96 with higher scores indicating greater frequency of memory and behavior problems exhibited by the person living with dementia (PLWD).
Outcome measures
| Measure |
Psychoeducational Intervention
n=50 Participants
Caregivers receiving the psychoeducational intervention immediately.
|
Waitlist Control Group
n=50 Participants
Caregivers on a waitlist to receive the psychoeducational intervention after a waiting period of 8 weeks.
|
|---|---|---|
|
Revised Memory and Behavior Problem Checklist (RMBPC) Frequency Score
Baseline
|
39.3 score on a scale
Standard Deviation 11.0
|
40.1 score on a scale
Standard Deviation 12.4
|
|
Revised Memory and Behavior Problem Checklist (RMBPC) Frequency Score
Week 8
|
39.0 score on a scale
Standard Deviation 11.8
|
38.2 score on a scale
Standard Deviation 13.4
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: This analysis includes participants who attended the indicated study visits and who provided complete information for the survey.
The RMBPC is a 24-item scale reporting on frequency of disturbing care recipient behaviors and severity or caregiver reactions to these behaviors. Respondents indicate the degree to which problems have bothered or upset them on a 5-point scale where 0 = not at all and 4 = extremely. Total reaction scores range from 0 to 96 with higher scores indicating more bothered or upset by memory and behavior problems exhibited by the PLWD.
Outcome measures
| Measure |
Psychoeducational Intervention
n=49 Participants
Caregivers receiving the psychoeducational intervention immediately.
|
Waitlist Control Group
n=50 Participants
Caregivers on a waitlist to receive the psychoeducational intervention after a waiting period of 8 weeks.
|
|---|---|---|
|
Revised Memory and Behavior Problem Checklist (RMBPC) Reaction Score
Week 8
|
14.9 score on a scale
Standard Deviation 9.0
|
16.3 score on a scale
Standard Deviation 14.1
|
|
Revised Memory and Behavior Problem Checklist (RMBPC) Reaction Score
Baseline
|
15.3 score on a scale
Standard Deviation 8.9
|
16.3 score on a scale
Standard Deviation 11.7
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: This analysis includes participants who attended the indicated study visits.
The Zarit Burden Interview is a 22-item scale of objective and subjective caregiver burden. Responses are given on a 5-point scale where 0 = never and 4 = nearly always. Total scores range from 0 to 88 where higher scores indicate greater feelings of being burdened with providing care.
Outcome measures
| Measure |
Psychoeducational Intervention
n=50 Participants
Caregivers receiving the psychoeducational intervention immediately.
|
Waitlist Control Group
n=50 Participants
Caregivers on a waitlist to receive the psychoeducational intervention after a waiting period of 8 weeks.
|
|---|---|---|
|
Zarit Burden Interview Score
Baseline
|
33.9 score on a scale
Standard Deviation 12.6
|
37.9 score on a scale
Standard Deviation 14.1
|
|
Zarit Burden Interview Score
Week 8
|
33.1 score on a scale
Standard Deviation 13.1
|
39.0 score on a scale
Standard Deviation 13.2
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: This analysis includes participants who attended the indicated study visits.
The Caregiving Mastery instrument assesses caregiver mastery of 3 different realms of caregiving situations: Relational Deprivation, Caregiving Competence, and Management of Situation. The Caregiving Competence section includes 4 items are responded to on a 4-point scale where 1 = not at all and 4 = completely. Total scores range from 4 to 16 where higher scores indicate greater feelings of mastery of caregiving.
Outcome measures
| Measure |
Psychoeducational Intervention
n=50 Participants
Caregivers receiving the psychoeducational intervention immediately.
|
Waitlist Control Group
n=50 Participants
Caregivers on a waitlist to receive the psychoeducational intervention after a waiting period of 8 weeks.
|
|---|---|---|
|
Caregiver Mastery Scales - Competency Score
Baseline
|
12.9 score on a scale
Standard Deviation 1.8
|
12.5 score on a scale
Standard Deviation 1.9
|
|
Caregiver Mastery Scales - Competency Score
Week 8
|
13.4 score on a scale
Standard Deviation 1.6
|
12.6 score on a scale
Standard Deviation 1.7
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: This analysis includes participants who attended the indicated study visits.
The Caregiver Assessment of Behavioral Skill - Self-report instrument is a 17-item caregiver self-assessment of perceived capacity to manage care situations. Responses are given on a 3-point scale where 0 = seldom true and 3 = true most of the time, for behaviors exhibited by or relevant to the PLWD. Total scores range from 0 to 51 where higher scores indicate perceived ability to manage providing care.
Outcome measures
| Measure |
Psychoeducational Intervention
n=50 Participants
Caregivers receiving the psychoeducational intervention immediately.
|
Waitlist Control Group
n=50 Participants
Caregivers on a waitlist to receive the psychoeducational intervention after a waiting period of 8 weeks.
|
|---|---|---|
|
Caregiver Assessment of Behavioral Skill - Self-report Score
Baseline
|
14.3 score on a scale
Standard Deviation 5.9
|
15.1 score on a scale
Standard Deviation 5.7
|
|
Caregiver Assessment of Behavioral Skill - Self-report Score
Week 8
|
14.1 score on a scale
Standard Deviation 6.7
|
14.4 score on a scale
Standard Deviation 4.9
|
Adverse Events
Psychoeducational Intervention Immediately
Psychoeducational Intervention After Waiting Period
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