Trial Outcomes & Findings for Improving Outcomes for Care Partners of Persons With Traumatic Brain Injury (NCT NCT04570930)
NCT ID: NCT04570930
Last Updated: 2024-09-19
Results Overview
TBI-CareQOL Caregiver Strain assesses perceived feelings of feeling overwhelmed, stressed and "beat-down" related to the care partner role. Self-reported responses are on a Likert scale. The measure is scored on a T metric with a mean of 50 and a standard deviation of 10. Higher scores indicate more strain.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
257 participants
Primary outcome timeframe
Baseline, Day 180 of intervention
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Just-in-time Adaptive Intervention (JITAI)
Participants will wear the Fitbit®, provide daily reports of Health- Related Quality of Life (HRQOL) and receive personalized pushes over a six-month (180 day) period.
Just-in-time adaptive intervention (JITAI): JITAI is an emerging intervention that incorporates passive mobile sensor data feedback (sleep and activity \[step\] data from a Fitbit ®), and real-time self-reporting of HRQOL via a study specific app called CareQOL to provide personalized feedback via app alert.
|
Control
Participants will wear the Fitbit® and provide daily reports of HRQOL over a six-month (180 day) period (without the personalized feedback).
Control: Participants will wear the Fitbit® and provide daily reports of HRQOL over a six-month (180 day) period.
|
|---|---|---|
|
Overall Study
STARTED
|
129
|
128
|
|
Overall Study
COMPLETED
|
122
|
122
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Outcomes for Care Partners of Persons With Traumatic Brain Injury
Baseline characteristics by cohort
| Measure |
Just-in-time Adaptive Intervention (JITAI)
n=129 Participants
Participants will wear the Fitbit®, provide daily reports of Health- Related Quality of Life (HRQOL) and receive personalized pushes over a six-month (180 day) period.
Just-in-time adaptive intervention (JITAI): JITAI is an emerging intervention that incorporates passive mobile sensor data feedback (sleep and activity \[step\] data from a Fitbit ®), and real-time self-reporting of HRQOL via a study specific app called CareQOL to provide personalized feedback via app alert.
|
Control
n=128 Participants
Participants will wear the Fitbit® and provide daily reports of HRQOL over a six-month (180 day) period (without the personalized feedback).
Control: Participants will wear the Fitbit® and provide daily reports of HRQOL over a six-month (180 day) period.
|
Total
n=257 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 15.3 • n=99 Participants
|
52 years
STANDARD_DEVIATION 14.3 • n=107 Participants
|
52 years
STANDARD_DEVIATION 14.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=99 Participants
|
103 Participants
n=107 Participants
|
204 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
107 Participants
n=99 Participants
|
109 Participants
n=107 Participants
|
216 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
98 Participants
n=99 Participants
|
100 Participants
n=107 Participants
|
198 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
129 Participants
n=99 Participants
|
128 Participants
n=107 Participants
|
257 Participants
n=206 Participants
|
|
Self-reported Caregiver Strain Measured by Traumatic Brain Injury Caregiver Quality of Life
|
51.0 T-score
STANDARD_DEVIATION 8.2 • n=99 Participants
|
49.3 T-score
STANDARD_DEVIATION 8.6 • n=107 Participants
|
50.1 T-score
STANDARD_DEVIATION 8.4 • n=206 Participants
|
|
Self-reported Anxiety Score Measured by Patient-Reported Outcomes Measurement Information System
|
57.5 T-score
STANDARD_DEVIATION 7.1 • n=99 Participants
|
56.1 T-score
STANDARD_DEVIATION 9.3 • n=107 Participants
|
56.8 T-score
STANDARD_DEVIATION 8.3 • n=206 Participants
|
|
Self-reported Depression Score Measured by Patient-Reported Outcomes Measurement Information System
|
53.5 T-score
STANDARD_DEVIATION 7.3 • n=99 Participants
|
53.0 T-score
STANDARD_DEVIATION 8.6 • n=107 Participants
|
53.3 T-score
STANDARD_DEVIATION 8.0 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 180 of interventionTBI-CareQOL Caregiver Strain assesses perceived feelings of feeling overwhelmed, stressed and "beat-down" related to the care partner role. Self-reported responses are on a Likert scale. The measure is scored on a T metric with a mean of 50 and a standard deviation of 10. Higher scores indicate more strain.
Outcome measures
| Measure |
Just-in-time Adaptive Intervention (JITAI)
n=122 Participants
Participants will wear the Fitbit®, provide daily reports of Health- Related Quality of Life (HRQOL) and receive personalized pushes over a six-month (180 day) period.
Just-in-time adaptive intervention (JITAI): JITAI is an emerging intervention that incorporates passive mobile sensor data feedback (sleep and activity \[step\] data from a Fitbit ®), and real-time self-reporting of HRQOL via a study specific app called CareQOL to provide personalized feedback via app alert.
|
Control
n=122 Participants
Participants will wear the Fitbit® and provide daily reports of HRQOL over a six-month (180 day) period (without the personalized feedback).
Control: Participants will wear the Fitbit® and provide daily reports of HRQOL over a six-month (180 day) period.
|
|---|---|---|
|
Change From Baseline in Self-reported Caregiver Strain as Measured by Traumatic Brain Injury Caregiver Quality of Life (TBI-CareQOL) Caregiver Strain
|
-1.09 T Score
Standard Deviation 7.76
|
0.34 T Score
Standard Deviation 6.53
|
SECONDARY outcome
Timeframe: Baseline, Day 180 of interventionPROMIS Anxiety assesses self-reported feelings of fear, anxiety and hyper-arousal. Self-reported responses are on a Likert scale. The measure is scored on a T metric with a mean of 50 and a standard deviation of 10. Higher scores indicate more anxiety.
Outcome measures
| Measure |
Just-in-time Adaptive Intervention (JITAI)
n=122 Participants
Participants will wear the Fitbit®, provide daily reports of Health- Related Quality of Life (HRQOL) and receive personalized pushes over a six-month (180 day) period.
Just-in-time adaptive intervention (JITAI): JITAI is an emerging intervention that incorporates passive mobile sensor data feedback (sleep and activity \[step\] data from a Fitbit ®), and real-time self-reporting of HRQOL via a study specific app called CareQOL to provide personalized feedback via app alert.
|
Control
n=122 Participants
Participants will wear the Fitbit® and provide daily reports of HRQOL over a six-month (180 day) period (without the personalized feedback).
Control: Participants will wear the Fitbit® and provide daily reports of HRQOL over a six-month (180 day) period.
|
|---|---|---|
|
Change From Baseline in Self-reported Anxiety Score as Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety
|
-1.14 T Score
Standard Deviation 7.58
|
0.60 T Score
Standard Deviation 8.23
|
SECONDARY outcome
Timeframe: Baseline, Day 180 of interventionPROMIS Depression assesses self-reported feelings of sadness and worthlessness. Self-reported responses are on a Likert scale. The measure is scored on a T metric with a mean of 50 and a standard deviation of 10. Higher scores indicate more depression.
Outcome measures
| Measure |
Just-in-time Adaptive Intervention (JITAI)
n=122 Participants
Participants will wear the Fitbit®, provide daily reports of Health- Related Quality of Life (HRQOL) and receive personalized pushes over a six-month (180 day) period.
Just-in-time adaptive intervention (JITAI): JITAI is an emerging intervention that incorporates passive mobile sensor data feedback (sleep and activity \[step\] data from a Fitbit ®), and real-time self-reporting of HRQOL via a study specific app called CareQOL to provide personalized feedback via app alert.
|
Control
n=122 Participants
Participants will wear the Fitbit® and provide daily reports of HRQOL over a six-month (180 day) period (without the personalized feedback).
Control: Participants will wear the Fitbit® and provide daily reports of HRQOL over a six-month (180 day) period.
|
|---|---|---|
|
Change From Baseline in Self-reported Depression Score as Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Depression
|
-1.01 T Score
Standard Deviation 7.12
|
0.61 T Score
Standard Deviation 7.75
|
Adverse Events
Just-in-time Adaptive Intervention (JITAI)
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Control
Serious events: 1 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Just-in-time Adaptive Intervention (JITAI)
n=129 participants at risk
Participants will wear the Fitbit®, provide daily reports of Health- Related Quality of Life (HRQOL) and receive personalized pushes over a six-month (180 day) period.
Just-in-time adaptive intervention (JITAI): JITAI is an emerging intervention that incorporates passive mobile sensor data feedback (sleep and activity \[step\] data from a Fitbit ®), and real-time self-reporting of HRQOL via a study specific app called CareQOL to provide personalized feedback via app alert.
|
Control
n=128 participants at risk
Participants will wear the Fitbit® and provide daily reports of HRQOL over a six-month (180 day) period (without the personalized feedback).
Control: Participants will wear the Fitbit® and provide daily reports of HRQOL over a six-month (180 day) period.
|
|---|---|---|
|
Infections and infestations
COVID-19
|
0.78%
1/129 • Number of events 1 • Baseline to Day 360
|
0.00%
0/128 • Baseline to Day 360
|
|
Endocrine disorders
Pancreatitis
|
0.00%
0/129 • Baseline to Day 360
|
0.78%
1/128 • Number of events 3 • Baseline to Day 360
|
Other adverse events
| Measure |
Just-in-time Adaptive Intervention (JITAI)
n=129 participants at risk
Participants will wear the Fitbit®, provide daily reports of Health- Related Quality of Life (HRQOL) and receive personalized pushes over a six-month (180 day) period.
Just-in-time adaptive intervention (JITAI): JITAI is an emerging intervention that incorporates passive mobile sensor data feedback (sleep and activity \[step\] data from a Fitbit ®), and real-time self-reporting of HRQOL via a study specific app called CareQOL to provide personalized feedback via app alert.
|
Control
n=128 participants at risk
Participants will wear the Fitbit® and provide daily reports of HRQOL over a six-month (180 day) period (without the personalized feedback).
Control: Participants will wear the Fitbit® and provide daily reports of HRQOL over a six-month (180 day) period.
|
|---|---|---|
|
Infections and infestations
COVID-19
|
4.7%
6/129 • Number of events 6 • Baseline to Day 360
|
7.0%
9/128 • Number of events 9 • Baseline to Day 360
|
|
Skin and subcutaneous tissue disorders
Skin irritation from Fitbit wristband
|
5.4%
7/129 • Number of events 8 • Baseline to Day 360
|
7.8%
10/128 • Number of events 10 • Baseline to Day 360
|
|
Social circumstances
Increased mental health problems
|
7.0%
9/129 • Number of events 13 • Baseline to Day 360
|
11.7%
15/128 • Number of events 22 • Baseline to Day 360
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place