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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR002240 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Participants will wear the Fitbit® and provide daily reports of health related quality of life (HRQOL) over a three-month (90 day) period (without the personalized feedback). |
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| Just-in-time adaptive intervention (JITAI) | Experimental | Participants will wear the Fitbit®, provide daily reports of health related quality of life (HRQOL) and receive personalized pushes over a three-month (90 day) period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Just-in-time adaptive intervention (JITAI) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 3 months of wearing the Fitbit and completing the surveys |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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Care Partner Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Noelle Carlozzi, Ph.D | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37707948 | Derived | Wang J, Wu Z, Choi SW, Sen S, Yan X, Miner JA, Sander AM, Lyden AK, Troost JP, Carlozzi NE. The Dosing of Mobile-Based Just-in-Time Adaptive Self-Management Prompts for Caregivers: Preliminary Findings From a Pilot Microrandomized Study. JMIR Form Res. 2023 Sep 14;7:e43099. doi: 10.2196/43099. | |
| 37358716 | Derived | Carlozzi NE, Choi SW, Wu Z, Sen S, Troost J, Lyden AK, Miner JA, Graves C, Sander AM. The reliability and validity of the TBI-CareQOL system in four diverse caregiver groups. J Patient Rep Outcomes. 2023 Jun 26;7(1):57. doi: 10.1186/s41687-023-00602-x. |
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Participant data collected during the trial, after de-identification, will be available for sharing with individuals in the scientific community, upon request. The data will be available after the acceptance for publication of the main findings from the final dataset. The University of Michigan Project Manager will coordinate requests for data and maintain documentation for requests and distributions. An institutional data use agreement will be required before data is shared.
The data will be available after the acceptance for publication of the main findings from the final dataset.
Data is available upon request to the project manager. Requests for data sharing should be emailed to PMR-CODAlab@med.umich.edu.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Two persons in the control arm were determined to be ineligible after they were enrolled and completed some study assessments. Both participants were determined to be ineligible by the principal investigator upon medical record review; the medical records did not provide sufficient documentation of spinal cord injury for the persons they cared for. These individuals are included in our summary of adverse events, but they are not included in other reporting as they were deemed ineligible.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | Just-in-time Adaptive Intervention (JITAI) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | one participant did not complete this measure | Posted | Count of Participants | Participants | 3 months of wearing the Fitbit and completing the surveys |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased stress (unrelated to study participation) | Social circumstances | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Noelle E. Carlozzi | University of Michigan | 734-764-0644 | PMR-CODAlab@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 22, 2021 | May 26, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 4, 2021 | May 4, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
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This behavioral trial will use a two-arm randomized controlled design.
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|
| Control | Behavioral | Participants will wear the Fitbit® and provide daily reports of HRQOL over a three-month (90 day) period |
|
| 3 months of wearing the Fitbit and completing the surveys |
| 36355640 | Derived | Carlozzi NE, Choi SW, Wu Z, Troost JP, Lyden AK, Miner JA, Graves CM, Wang J, Yan X, Sen S. An app-based just-in-time-adaptive self-management intervention for care partners: The CareQOL feasibility pilot study. Rehabil Psychol. 2022 Nov;67(4):497-512. doi: 10.1037/rep0000472. |
| 34889775 | Derived | Carlozzi NE, Choi SW, Wu Z, Miner JA, Lyden AK, Graves C, Wang J, Sen S. An App-Based Just-in-Time Adaptive Self-management Intervention for Care Partners (CareQOL): Protocol for a Pilot Trial. JMIR Res Protoc. 2021 Dec 9;10(12):e32842. doi: 10.2196/32842. |
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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Caregiver group | Count of Participants | Participants |
|
|
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| Secondary | Attrition as Measured by the Percent of Participants Completing the Study | Posted | Count of Participants | Participants | 3 months of wearing the Fitbit and completing the surveys |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | percentage of data | 3 months of wearing the Fitbit and completing the surveys |
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| 0 |
| 34 |
| 0 |
| 34 |
| 1 |
| 34 |
| EG001 | 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. | 0 | 36 | 0 | 36 | 2 | 36 |
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| D012893 |
| Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| Daily Sleep |
|