Caregivers
Conditions
Keywords
Depression, Insomnia, Stress related disorders, Anxiety
Brief summary
The purpose of this study is to test whether personalized messages from an easy-to-use mobile app improve mood and stress among care partners and to see if care partners like using the app.
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 three-month (90 day) period
Sponsors
National Center for Advancing Translational Sciences (NCATS)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
This behavioral trial will use a two-arm randomized controlled design.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Care Partner Inclusion Criteria: * Provide emotional, physical, and/or financial support/assistance to an individual with spinal cord injury (SCI), Huntington's Disease (HD), or hematopoietic cell transplantation (HCT) * 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 * Care partners of persons with HD: Be caring for an adult (18 years or older) with a clinical diagnosis of HD * Care partners of persons with SCI: Be caring for an adult (18 years or older) that is ≥1 post-injury and sustained a medically documented SCI at age 16 or older * Care partners of persons with HCT: Be caring for an adult (18 years or older) who is receiving, has received or is scheduled to receive HCT
Exclusion criteria
* Is a professional, paid caregiver (e.g., home health aide)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility and Acceptability as Measured by the Percentage of Agree or Strongly Agree Responses to the Individual Items on the Feasibility Questionnaire | 3 months of wearing the Fitbit and completing the surveys | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Attrition as Measured by the Percent of Participants Completing the Study | 3 months of wearing the Fitbit and completing the surveys | — |
| Adherence as Measured by the Percentage of Contributed Data Over the Course of the Study | 3 months of wearing the Fitbit and completing the surveys | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 34 |
| 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. | 36 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Ineligible after medical record review; documentation for SCI not sufficient | 2 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Control | Just-in-time Adaptive Intervention (JITAI) | Total |
|---|---|---|---|
| Age, Continuous | 56.1 years STANDARD_DEVIATION 14.5 | 54.4 years STANDARD_DEVIATION 13.1 | 55.2 years STANDARD_DEVIATION 13.7 |
| Caregiver group Hematopoietic cell transplantation (HCT) | 15 Participants | 15 Participants | 30 Participants |
| Caregiver group Huntington Disease (HD) | 10 Participants | 11 Participants | 21 Participants |
| Caregiver group Spinal Cord Injury (SCI) | 9 Participants | 10 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants | 33 Participants | 67 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 33 Participants | 29 Participants | 62 Participants |
| Region of Enrollment United States | 34 Participants | 36 Participants | 70 Participants |
| Sex/Gender, Customized Do not wish to report | 1 Participants | 0 Participants | 1 Participants |
| Sex/Gender, Customized Female | 21 Participants | 28 Participants | 49 Participants |
| Sex/Gender, Customized Male | 12 Participants | 8 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 36 |
| other Total, other adverse events | 1 / 34 | 2 / 36 |
| serious Total, serious adverse events | 0 / 34 | 0 / 36 |
Outcome results
Primary
Feasibility and Acceptability as Measured by the Percentage of Agree or Strongly Agree Responses to the Individual Items on the Feasibility Questionnaire
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).
Time frame: 3 months of wearing the Fitbit and completing the surveys
Population: one participant did not complete this measure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants, in a Whole Sample | 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 |
| All Participants, in a Whole Sample | 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 |
| All Participants, in a Whole Sample | 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 |
| All Participants, in a Whole Sample | 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 |
| All Participants, in a Whole Sample | 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 |
| All Participants, in a Whole Sample | 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 |
| All Participants, in a Whole Sample | 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 |
| All Participants, in a Whole Sample | 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 |
| All Participants, in a Whole Sample | 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 |
| All Participants, in a Whole Sample | 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 |
| All Participants, in a Whole Sample | 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 |
| All Participants, in a Whole Sample | 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 |
| All Participants, in a Whole Sample | 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 |
| All Participants, in a Whole Sample | 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 |
| All Participants, in a Whole Sample | 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 |
| All Participants, in a Whole Sample | 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 |
| All Participants, in a Whole Sample | 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 |
| All Participants, in a Whole Sample | 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 |
| All Participants, in a Whole Sample | 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
Adherence as Measured by the Percentage of Contributed Data Over the Course of the Study
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.
Time frame: 3 months of wearing the Fitbit and completing the surveys
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants, in a Whole Sample | Adherence as Measured by the Percentage of Contributed Data Over the Course of the Study | Daily Sleep | 82 percentage of data | Standard Deviation 29 |
| All Participants, in a Whole Sample | Adherence as Measured by the Percentage of Contributed Data Over the Course of the Study | Daily survey | 90 percentage of data | Standard Deviation 12 |
| All Participants, in a Whole Sample | Adherence as Measured by the Percentage of Contributed Data Over the Course of the Study | Daily Steps | 98 percentage of data | Standard Deviation 2 |
| SCI Care Partners | Adherence as Measured by the Percentage of Contributed Data Over the Course of the Study | Daily Sleep | 80 percentage of data | Standard Deviation 27 |
| SCI Care Partners | Adherence as Measured by the Percentage of Contributed Data Over the Course of the Study | Daily survey | 84 percentage of data | Standard Deviation 14 |
| SCI Care Partners | Adherence as Measured by the Percentage of Contributed Data Over the Course of the Study | Daily Steps | 90 percentage of data | Standard Deviation 18 |
| HCT Care Partners | Adherence as Measured by the Percentage of Contributed Data Over the Course of the Study | Daily Sleep | 90 percentage of data | Standard Deviation 21 |
| HCT Care Partners | Adherence as Measured by the Percentage of Contributed Data Over the Course of the Study | Daily survey | 92 percentage of data | Standard Deviation 8 |
| HCT Care Partners | Adherence as Measured by the Percentage of Contributed Data Over the Course of the Study | Daily Steps | 99 percentage of data | Standard Deviation 2 |
Secondary
Attrition as Measured by the Percent of Participants Completing the Study
Time frame: 3 months of wearing the Fitbit and completing the surveys
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants, in a Whole Sample | Attrition as Measured by the Percent of Participants Completing the Study | 69 Participants |