Trial Outcomes & Findings for Mobile Technology and Data Analytics to Identify Real-time Predictors of Caregiver Well-Being (NCT NCT04556591)
NCT ID: NCT04556591
Last Updated: 2023-03-21
Results Overview
Items are scaled from 1 to 5 to indicate the level of agreement, where "1" indicates "strong disagreement" and "5" indicates "strong agreement". Percentages shown are the combined percentage of participants who selected "agree" or "strongly agree" or their equivalent (as labeled).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
72 participants
Primary outcome timeframe
3 months of wearing the Fitbit and completing the surveys
Results posted on
2023-03-21
Participant Flow
Participant milestones
| Measure |
Control
Participants wore the Fitbit® and provided daily reports of health related quality of life (HRQOL) over a three-month (90 day) period (without the personalized feedback).
|
Just-in-time Adaptive Intervention (JITAI)
Participants wore the Fitbit®, provided daily reports of health related quality of life (HRQOL) and received personalized pushes over a three-month (90 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.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
36
|
|
Overall Study
COMPLETED
|
33
|
36
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Control
Participants wore the Fitbit® and provided daily reports of health related quality of life (HRQOL) over a three-month (90 day) period (without the personalized feedback).
|
Just-in-time Adaptive Intervention (JITAI)
Participants wore the Fitbit®, provided daily reports of health related quality of life (HRQOL) and received personalized pushes over a three-month (90 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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Ineligible after medical record review; documentation for SCI not sufficient
|
2
|
0
|
Baseline Characteristics
Mobile Technology and Data Analytics to Identify Real-time Predictors of Caregiver Well-Being
Baseline characteristics by cohort
| Measure |
Control
n=34 Participants
Participants wore the Fitbit® and provided daily reports of health related quality of life (HRQOL) over a three-month (90 day) period (without the personalized feedback).
|
Just-in-time Adaptive Intervention (JITAI)
n=36 Participants
Participants wore the Fitbit®, provided daily reports of health related quality of life (HRQOL) and received personalized pushes over a three-month (90 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.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.1 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
54.4 years
STANDARD_DEVIATION 13.1 • n=7 Participants
|
55.2 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
21 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Do not wish to report
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Caregiver group
Huntington Disease (HD)
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Caregiver group
Spinal Cord Injury (SCI)
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Caregiver group
Hematopoietic cell transplantation (HCT)
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months of wearing the Fitbit and completing the surveysPopulation: one participant did not complete this measure
Items are scaled from 1 to 5 to indicate the level of agreement, where "1" indicates "strong disagreement" and "5" indicates "strong agreement". Percentages shown are the combined percentage of participants who selected "agree" or "strongly agree" or their equivalent (as labeled).
Outcome measures
| Measure |
All Participants, in a Whole Sample
n=69 Participants
Aggregate data is presented for feasibility and acceptability measures; involvement in the trial is presented for the combined sample as the primary outcome relates to the feasibility and acceptability of the study design rather than the effectiveness of the intervention.
|
SCI Care Partners
Data is presented for the SCI Care Partner group for feasibility and acceptability measures.
|
HCT Care Partners
Data is presented for the HCT Care Partner group for feasibility and acceptability measures.
|
|---|---|---|---|
|
Feasibility and Acceptability as Measured by the Percentage of Agree or Strongly Agree Responses to the Individual Items on the Feasibility Questionnaire
The CareQOL app was easy to use.
|
67 Participants
|
—
|
—
|
|
Feasibility and Acceptability as Measured by the Percentage of Agree or Strongly Agree Responses to the Individual Items on the Feasibility Questionnaire
I was confident using the CareQOL app
|
67 Participants
|
—
|
—
|
|
Feasibility and Acceptability as Measured by the Percentage of Agree or Strongly Agree Responses to the Individual Items on the Feasibility Questionnaire
I am confident that I was using the CareQOL app correctly.
|
65 Participants
|
—
|
—
|
|
Feasibility and Acceptability as Measured by the Percentage of Agree or Strongly Agree Responses to the Individual Items on the Feasibility Questionnaire
The daily questions on the app were easy to understand.
|
65 Participants
|
—
|
—
|
|
Feasibility and Acceptability as Measured by the Percentage of Agree or Strongly Agree Responses to the Individual Items on the Feasibility Questionnaire
Instructions for the Fitbit®️ were easy to understand.
|
62 Participants
|
—
|
—
|
|
Feasibility and Acceptability as Measured by the Percentage of Agree or Strongly Agree Responses to the Individual Items on the Feasibility Questionnaire
The Fitbit® was easy to set up.
|
63 Participants
|
—
|
—
|
|
Feasibility and Acceptability as Measured by the Percentage of Agree or Strongly Agree Responses to the Individual Items on the Feasibility Questionnaire
The Fitbit® was easy to use.
|
64 Participants
|
—
|
—
|
|
Feasibility and Acceptability as Measured by the Percentage of Agree or Strongly Agree Responses to the Individual Items on the Feasibility Questionnaire
The Fitbit® was comfortable to wear.
|
60 Participants
|
—
|
—
|
|
Feasibility and Acceptability as Measured by the Percentage of Agree or Strongly Agree Responses to the Individual Items on the Feasibility Questionnaire
The Fitbit® was easy to sync with my phone.
|
58 Participants
|
—
|
—
|
|
Feasibility and Acceptability as Measured by the Percentage of Agree or Strongly Agree Responses to the Individual Items on the Feasibility Questionnaire
I was confident using the Fitbit®
|
59 Participants
|
—
|
—
|
|
Feasibility and Acceptability as Measured by the Percentage of Agree or Strongly Agree Responses to the Individual Items on the Feasibility Questionnaire
The instructions for the CareQOL app set up were easy to understand.
|
66 Participants
|
—
|
—
|
|
Feasibility and Acceptability as Measured by the Percentage of Agree or Strongly Agree Responses to the Individual Items on the Feasibility Questionnaire
The CareQOL app was easy to set up.
|
65 Participants
|
—
|
—
|
|
Feasibility and Acceptability as Measured by the Percentage of Agree or Strongly Agree Responses to the Individual Items on the Feasibility Questionnaire
The daily questions on the app were easy to answer.
|
62 Participants
|
—
|
—
|
|
Feasibility and Acceptability as Measured by the Percentage of Agree or Strongly Agree Responses to the Individual Items on the Feasibility Questionnaire
Answering the daily questions fit easily into my routine.
|
62 Participants
|
—
|
—
|
|
Feasibility and Acceptability as Measured by the Percentage of Agree or Strongly Agree Responses to the Individual Items on the Feasibility Questionnaire
The number of daily questions to answer on the app was reasonable.
|
69 Participants
|
—
|
—
|
|
Feasibility and Acceptability as Measured by the Percentage of Agree or Strongly Agree Responses to the Individual Items on the Feasibility Questionnaire
The monthly surveys on the app were easy to understand.
|
66 Participants
|
—
|
—
|
|
Feasibility and Acceptability as Measured by the Percentage of Agree or Strongly Agree Responses to the Individual Items on the Feasibility Questionnaire
The monthly surveys on the app were easy to answer.
|
63 Participants
|
—
|
—
|
|
Feasibility and Acceptability as Measured by the Percentage of Agree or Strongly Agree Responses to the Individual Items on the Feasibility Questionnaire
Answering the monthly surveys fit easily into my routine.
|
65 Participants
|
—
|
—
|
|
Feasibility and Acceptability as Measured by the Percentage of Agree or Strongly Agree Responses to the Individual Items on the Feasibility Questionnaire
The number of questions in the monthly surveys was reasonable.
|
63 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 months of wearing the Fitbit and completing the surveysOutcome measures
| Measure |
All Participants, in a Whole Sample
n=70 Participants
Aggregate data is presented for feasibility and acceptability measures; involvement in the trial is presented for the combined sample as the primary outcome relates to the feasibility and acceptability of the study design rather than the effectiveness of the intervention.
|
SCI Care Partners
Data is presented for the SCI Care Partner group for feasibility and acceptability measures.
|
HCT Care Partners
Data is presented for the HCT Care Partner group for feasibility and acceptability measures.
|
|---|---|---|---|
|
Attrition as Measured by the Percent of Participants Completing the Study
|
69 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 months of wearing the Fitbit and completing the surveysPopulation: Data are presented separately by caregiver group to inform future caregiver studies that may elect to focus on a single caregiver group, as opposed to caregivers more generally.
Contributed data percentages are shown by caregiver group (HD, SCI, HCT) for daily surveys, daily steps, daily sleep, calculated by number of days of data provided divided by number of total possible days that it could be provided.
Outcome measures
| Measure |
All Participants, in a Whole Sample
n=21 Participants
Aggregate data is presented for feasibility and acceptability measures; involvement in the trial is presented for the combined sample as the primary outcome relates to the feasibility and acceptability of the study design rather than the effectiveness of the intervention.
|
SCI Care Partners
n=19 Participants
Data is presented for the SCI Care Partner group for feasibility and acceptability measures.
|
HCT Care Partners
n=30 Participants
Data is presented for the HCT Care Partner group for feasibility and acceptability measures.
|
|---|---|---|---|
|
Adherence as Measured by the Percentage of Contributed Data Over the Course of the Study
Daily survey
|
90 percentage of data
Standard Deviation 12
|
84 percentage of data
Standard Deviation 14
|
92 percentage of data
Standard Deviation 8
|
|
Adherence as Measured by the Percentage of Contributed Data Over the Course of the Study
Daily Steps
|
98 percentage of data
Standard Deviation 2
|
90 percentage of data
Standard Deviation 18
|
99 percentage of data
Standard Deviation 2
|
|
Adherence as Measured by the Percentage of Contributed Data Over the Course of the Study
Daily Sleep
|
82 percentage of data
Standard Deviation 29
|
80 percentage of data
Standard Deviation 27
|
90 percentage of data
Standard Deviation 21
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Just-in-time Adaptive Intervention (JITAI)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control
n=34 participants at risk
Participants wore the Fitbit® and provided daily reports of health related quality of life (HRQOL) over a three-month (90 day) period (without the personalized feedback).
|
Just-in-time Adaptive Intervention (JITAI)
n=36 participants at risk
Participants wore the Fitbit®, provided daily reports of health related quality of life (HRQOL) and received personalized pushes over a three-month (90 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.
|
|---|---|---|
|
Social circumstances
Increased stress (unrelated to study participation)
|
2.9%
1/34 • Number of events 1 • Three months
Two persons in the control arm were determined to be ineligible after they were enrolled. Both participants were determined to be ineligible by the principal investigator upon medical record review; the medical records did not provide sufficient documentation to support a spinal cord injury diagnosis for the persons they cared for. Thus, the data for these two participants is not included since they did not meet study eligibility requirements.
|
5.6%
2/36 • Number of events 2 • Three months
Two persons in the control arm were determined to be ineligible after they were enrolled. Both participants were determined to be ineligible by the principal investigator upon medical record review; the medical records did not provide sufficient documentation to support a spinal cord injury diagnosis for the persons they cared for. Thus, the data for these two participants is not included since they did not meet study eligibility requirements.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place