Caregivers
Conditions
Keywords
Stress, Anxiety, Depression
Brief summary
Care partners of persons with traumatic brain injury (TBI) are often faced with considerable physical and emotional stress resulting from their caregiver role. The researchers hypothesize that the care partners who receive the intervention will show improvements in caregiver strain and mental health.
Interventions
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.
BEHAVIORALControl
Participants will wear the Fitbit® and provide daily reports of HRQOL over a six-month (180 day) period.
Sponsors
National Institute of Nursing Research (NINR)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This behavioral trial will use a 2-arm randomized controlled design.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Be caring for an adult (age 18 or above) with a medically documented TBI that is ≥1-year post-injury and meets the TBI Model Systems (TBIMS) criteria for complicated mild, moderate or severe TBI and who sustained their TBI at age 16 or older * Provide emotional, physical, and/or financial support/assistance to the individual with the TBI, indicating a response ≥1 to the following question: On a scale of 0-10, where 0 is no assistance and 10 is assistance with all activities, how much assistance does the person you care for require from you to complete activities of daily living due to problems resulting from his/her TBI? Activities could consist of personal hygiene, dressing and undressing, housework, taking medications, managing money, running errands, shopping for groceries or clothing, transportation, meal preparation and cleanup, remembering things, etc. * Have access to necessary resources for participating in a technology-based intervention (smartphone/tablet and internet access) and be willing to use their personal equipment/internet for this study, including downloading the study app and the Fitbit® app on their mobile device * Is able and willing to complete all study assessments for the duration of their study participation (approximately 375 days)
Exclusion criteria
* Is a professional, paid caregiver (e.g., home health aide) * Anything that would preclude safe or meaningful participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Self-reported Caregiver Strain as Measured by Traumatic Brain Injury Caregiver Quality of Life (TBI-CareQOL) Caregiver Strain | Baseline, Day 180 of intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Self-reported Anxiety Score as Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety | Baseline, Day 180 of intervention | PROMIS 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. |
| Change From Baseline in Self-reported Depression Score as Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Depression | Baseline, Day 180 of intervention | PROMIS 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 129 |
| 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. | 128 |
| Total | 257 |
Baseline characteristics
| Characteristic | Total | Control | Just-in-time Adaptive Intervention (JITAI) |
|---|---|---|---|
| Age, Continuous | 52 years STANDARD_DEVIATION 14.8 | 52 years STANDARD_DEVIATION 14.3 | 52 years STANDARD_DEVIATION 15.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 41 Participants | 19 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 216 Participants | 109 Participants | 107 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 36 Participants | 16 Participants | 20 Participants |
| Race (NIH/OMB) More than one race | 8 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 198 Participants | 100 Participants | 98 Participants |
| Region of Enrollment United States | 257 Participants | 128 Participants | 129 Participants |
| Self-reported Anxiety Score Measured by Patient-Reported Outcomes Measurement Information System | 56.8 T-score STANDARD_DEVIATION 8.3 | 56.1 T-score STANDARD_DEVIATION 9.3 | 57.5 T-score STANDARD_DEVIATION 7.1 |
| Self-reported Caregiver Strain Measured by Traumatic Brain Injury Caregiver Quality of Life | 50.1 T-score STANDARD_DEVIATION 8.4 | 49.3 T-score STANDARD_DEVIATION 8.6 | 51.0 T-score STANDARD_DEVIATION 8.2 |
| Self-reported Depression Score Measured by Patient-Reported Outcomes Measurement Information System | 53.3 T-score STANDARD_DEVIATION 8 | 53.0 T-score STANDARD_DEVIATION 8.6 | 53.5 T-score STANDARD_DEVIATION 7.3 |
| Sex: Female, Male Female | 204 Participants | 103 Participants | 101 Participants |
| Sex: Female, Male Male | 53 Participants | 25 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 129 | 0 / 128 |
| other Total, other adverse events | 17 / 129 | 32 / 128 |
| serious Total, serious adverse events | 1 / 129 | 1 / 128 |
Outcome results
Primary
Change From Baseline in Self-reported Caregiver Strain as Measured by Traumatic Brain Injury Caregiver Quality of Life (TBI-CareQOL) Caregiver Strain
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.
Time frame: Baseline, Day 180 of intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Just-in-time Adaptive Intervention (JITAI) | 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 |
| Control | Change From Baseline in Self-reported Caregiver Strain as Measured by Traumatic Brain Injury Caregiver Quality of Life (TBI-CareQOL) Caregiver Strain | 0.34 T Score | Standard Deviation 6.53 |
Secondary
Change From Baseline in Self-reported Anxiety Score as Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety
PROMIS 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.
Time frame: Baseline, Day 180 of intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Just-in-time Adaptive Intervention (JITAI) | 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 |
| Control | Change From Baseline in Self-reported Anxiety Score as Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety | 0.60 T Score | Standard Deviation 8.23 |
Secondary
Change From Baseline in Self-reported Depression Score as Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Depression
PROMIS 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.
Time frame: Baseline, Day 180 of intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Just-in-time Adaptive Intervention (JITAI) | 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 |
| Control | Change From Baseline in Self-reported Depression Score as Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Depression | 0.61 T Score | Standard Deviation 7.75 |