Trial Outcomes & Findings for Caregiver Speaks: A Technologically Mediated Storytelling Intervention (NCT NCT04103580)
NCT ID: NCT04103580
Last Updated: 2025-02-26
Results Overview
Caregiver anxiety measure. Response options range from 0 (not at all) to 3 (nearly every day), with total scores ranging from 0 to 21. Higher scores indicate more anxiety.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
457 participants
Primary outcome timeframe
Data were collected at baseline, 14, 30, 90, 150 days in active caregiving phase and 14, 30, 90, 150, and 180 days in bereavement phase. Follow-up data were included in the calculation of score change per day as long as participant had 1 followup.
Results posted on
2025-02-26
Participant Flow
Enrollment considered complete and random assignment made only after the baseline survey was completed. The baseline analysis population excludes those who were not truly randomized. Some participants who cared for the same patient were assigned to the same group (without any randomization) as the first participant from that cohort who was truly randomized. These are recorded as "Not truly randomized" as a category of participants under "Incomplete" in each phase.
Participant milestones
| Measure |
Control
Will receive usual hospice care plus measures
|
Intervention
Will receive photo elicitation intervention and will join a secret Facebook group to share photos with other caregivers
Photo elicitation: Caregivers are taught to use photos to illustrate various feelings and meanings
|
|---|---|---|
|
Phase 1 Active Caregiving
STARTED
|
227
|
230
|
|
Phase 1 Active Caregiving
COMPLETED
|
144
|
113
|
|
Phase 1 Active Caregiving
NOT COMPLETED
|
83
|
117
|
|
Phase 2 Bereavement
STARTED
|
134
|
85
|
|
Phase 2 Bereavement
COMPLETED
|
117
|
62
|
|
Phase 2 Bereavement
NOT COMPLETED
|
17
|
23
|
Reasons for withdrawal
| Measure |
Control
Will receive usual hospice care plus measures
|
Intervention
Will receive photo elicitation intervention and will join a secret Facebook group to share photos with other caregivers
Photo elicitation: Caregivers are taught to use photos to illustrate various feelings and meanings
|
|---|---|---|
|
Phase 1 Active Caregiving
Lost to Follow-up
|
18
|
45
|
|
Phase 1 Active Caregiving
Withdrawal by Subject
|
5
|
14
|
|
Phase 1 Active Caregiving
Decertified from Hospice
|
3
|
1
|
|
Phase 1 Active Caregiving
Care Recipient Died before First Follow-up
|
41
|
35
|
|
Phase 1 Active Caregiving
Not truly randomized (cohort-randomized with other family caregivers)
|
13
|
19
|
|
Phase 1 Active Caregiving
Other
|
3
|
3
|
|
Phase 2 Bereavement
Lost to Follow-up
|
2
|
6
|
|
Phase 2 Bereavement
Withdrawal by Subject
|
1
|
4
|
|
Phase 2 Bereavement
Not truly randomized (cohort-randomized with other family caregivers)
|
6
|
7
|
|
Phase 2 Bereavement
Other
|
8
|
6
|
Baseline Characteristics
7 Participants were missing age data.
Baseline characteristics by cohort
| Measure |
Control
n=214 Participants
Will receive usual hospice care plus measures
|
Intervention
n=211 Participants
Will receive photo elicitation intervention and will join a secret Facebook group to share photos with other caregivers
Photo elicitation: Caregivers are taught to use photos to illustrate various feelings and meanings
|
Total
n=425 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.2 years
STANDARD_DEVIATION 11.0 • n=212 Participants • 7 Participants were missing age data.
|
60.7 years
STANDARD_DEVIATION 9.69 • n=206 Participants • 7 Participants were missing age data.
|
60.5 years
STANDARD_DEVIATION 10.4 • n=418 Participants • 7 Participants were missing age data.
|
|
Sex/Gender, Customized
Sex · Female
|
176 Participants
n=214 Participants
|
174 Participants
n=211 Participants
|
350 Participants
n=425 Participants
|
|
Sex/Gender, Customized
Sex · Male
|
36 Participants
n=214 Participants
|
37 Participants
n=211 Participants
|
73 Participants
n=425 Participants
|
|
Sex/Gender, Customized
Sex · Other
|
1 Participants
n=214 Participants
|
0 Participants
n=211 Participants
|
1 Participants
n=425 Participants
|
|
Sex/Gender, Customized
Sex · Unknown
|
1 Participants
n=214 Participants
|
0 Participants
n=211 Participants
|
1 Participants
n=425 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=214 Participants
|
9 Participants
n=211 Participants
|
12 Participants
n=425 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
207 Participants
n=214 Participants
|
196 Participants
n=211 Participants
|
403 Participants
n=425 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=214 Participants
|
6 Participants
n=211 Participants
|
10 Participants
n=425 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=214 Participants
|
0 Participants
n=211 Participants
|
1 Participants
n=425 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=214 Participants
|
1 Participants
n=211 Participants
|
2 Participants
n=425 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=214 Participants
|
0 Participants
n=211 Participants
|
1 Participants
n=425 Participants
|
|
Race (NIH/OMB)
Black or African American
|
39 Participants
n=214 Participants
|
36 Participants
n=211 Participants
|
75 Participants
n=425 Participants
|
|
Race (NIH/OMB)
White
|
166 Participants
n=214 Participants
|
162 Participants
n=211 Participants
|
328 Participants
n=425 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=214 Participants
|
4 Participants
n=211 Participants
|
6 Participants
n=425 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=214 Participants
|
8 Participants
n=211 Participants
|
12 Participants
n=425 Participants
|
|
GAD-7
|
8.33 units on a scale
STANDARD_DEVIATION 5.92 • n=204 Participants • 25 participants were missing data on at least 1 item required to calculate a total GAD-7 score.
|
8.41 units on a scale
STANDARD_DEVIATION 5.29 • n=196 Participants • 25 participants were missing data on at least 1 item required to calculate a total GAD-7 score.
|
8.37 units on a scale
STANDARD_DEVIATION 5.61 • n=400 Participants • 25 participants were missing data on at least 1 item required to calculate a total GAD-7 score.
|
|
PHQ-9
|
7.20 units on a scale
STANDARD_DEVIATION 6.39 • n=198 Participants • 28 participants were missing data on at least one of the items required to calculated a total PHQ-9 score.
|
7.31 units on a scale
STANDARD_DEVIATION 5.63 • n=199 Participants • 28 participants were missing data on at least one of the items required to calculated a total PHQ-9 score.
|
7.25 units on a scale
STANDARD_DEVIATION 6.01 • n=397 Participants • 28 participants were missing data on at least one of the items required to calculated a total PHQ-9 score.
|
PRIMARY outcome
Timeframe: Data were collected at baseline, 14, 30, 90, 150 days in active caregiving phase and 14, 30, 90, 150, and 180 days in bereavement phase. Follow-up data were included in the calculation of score change per day as long as participant had 1 followup.Population: Each analysis population includes participants that had at least one follow-up after first measure in each phase.
Caregiver anxiety measure. Response options range from 0 (not at all) to 3 (nearly every day), with total scores ranging from 0 to 21. Higher scores indicate more anxiety.
Outcome measures
| Measure |
Control - Phase 1
n=137 Participants
Control group in active caregiving
|
Intervention - Phase 1
n=108 Participants
Intervention group in active caregiving
|
Control - Phase 2
n=112 Participants
Control group in bereavement
|
Intervention - Phase 2
n=61 Participants
Intervention group in bereavement
|
|---|---|---|---|---|
|
Generalized Anxiety Disorder-7 (GAD-7) Anxiety Score
|
-0.014 score on a scale change per day
Standard Error 0.003
|
-0.008 score on a scale change per day
Standard Error 0.004
|
-0.005 score on a scale change per day
Standard Error 0.002
|
-0.013 score on a scale change per day
Standard Error 0.003
|
PRIMARY outcome
Timeframe: Data were collected at baseline, 14, 30, 90, 150 days in active caregiving phase and 14, 30, 90, 150, and 180 days in bereavement phase. Follow-up data were included in the calculation of score change per day as long as participant had 1 followup.Population: Each analysis population includes participants that had at least one follow-up after first measure in each phase.
Caregiver depression measure. Response options range from 0 (not at all) to 3 (nearly every day), with total scores ranging from 0 to 27. Higher scores indicate more depression.
Outcome measures
| Measure |
Control - Phase 1
n=131 Participants
Control group in active caregiving
|
Intervention - Phase 1
n=105 Participants
Intervention group in active caregiving
|
Control - Phase 2
n=112 Participants
Control group in bereavement
|
Intervention - Phase 2
n=61 Participants
Intervention group in bereavement
|
|---|---|---|---|---|
|
Patient Health Questionnaire-9 (PHQ-9) Depression Score
|
-0.007 score on a scale change per day
Standard Error 0.003
|
-0.001 score on a scale change per day
Standard Error 0.003
|
-0.011 score on a scale change per day
Standard Error 0.002
|
-0.013 score on a scale change per day
Standard Error 0.003
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention
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
Kyle Pitzer: Study Statistical Data Analyst
Washington University
Phone: 314-747-5361
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place