CaregiversNCT04556591

Mobile Technology and Data Analytics to Identify Real-time Predictors of Caregiver Well-Being

A study testing Just-in-time adaptive intervention (JITAI) in people with Caregivers, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Caregivers
What is being tested?: Just-in-time adaptive intervention (JITAI)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 1 siteUnited States
Study dates: 5 Nov 2020to 7 Jun 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

Is a professional, paid caregiver (e.g., home health aide)

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of Michigan
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

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.

Conditions: Caregivers
Being tested: Just-in-time adaptive intervention (JITAI), Control
Keywords: Depression, Insomnia, Stress related disorders, Anxiety
Medical subject headings: Depression, Sleep Initiation and Maintenance Disorders, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Just-in-time adaptive intervention (JITAI)Behavioural
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.
ControlBehavioural
Participants will wear the Fitbit® and provide daily reports of HRQOL over a three-month (90 day) period

Study groups in NCT04556591
Study group	Role	What they receive
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). Receives: Behavioral: Control
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. Receives: Behavioral: Just-in-time adaptive intervention (JITAI)

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 3 months of wearing the Fitbit and completing the surveys

Secondary outcomes (2)

Attrition as Measured by the Percent of Participants Completing the Study
Measured: 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.
Measured: 3 months of wearing the Fitbit and completing the surveys

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Nov 20207 Jun 2021

First posted21 Sep 2020
Study start5 Nov 2020
Primary completion7 Jun 2021
Study completion7 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for CaregiversStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Model description: This behavioral trial will use a two-arm randomized controlled design.
Masking: None (open label)
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04556591
Sponsor's protocol ID: HUM00184455
Other IDs: UL1TR002240
Status last verified: Feb 2023
First submitted: 14 Sep 2020
Last updated: 21 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

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.
PubMed 37707948
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.
PubMed 37358716
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.
PubMed 36355640
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.
PubMed 34889775

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Caregivers trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mobile Technology and Data Analytics to Identify Real-time Predictors of Caregiver Well-Being
ClinicalTrials.gov ID: NCT04556591
Acronym / sponsor ID: HUM00184455
Conditions: Caregivers
Keywords: Depression, Insomnia, Stress related disorders, Anxiety
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Collaborators: National Center for Advancing Translational Sciences (NCATS)
Study start: 5 Nov 2020 (actual)
Primary completion: 7 Jun 2021 (actual)
Study completion: 7 Jun 2021 (actual)
First posted: 21 Sep 2020 (actual)
Results: Posted 21 Mar 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: This behavioral trial will use a two-arm randomized controlled design.

Arm	Type	Receives
Control	Active comparator	Behavioral: ControlParticipants 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).
Just-in-time adaptive intervention (JITAI)	Experimental	Behavioral: 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 three-month (90 day) period.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (1 listed)

Is a professional, paid caregiver (e.g., home health aide)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Behavioural	Just-in-time adaptive intervention (JITAI)
ControlParticipants will wear the Fitbit® and provide daily reports of HRQOL over a three-month (90 day) period	Behavioural	Control

Primary outcome

Feasibility and Acceptability as Measured by the Percentage of Agree or Strongly Agree Responses to the Individual Items on the Feasibility Questionnaire
Time frame: 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).

2 secondary outcomes

Attrition as Measured by the Percent of Participants Completing the Study
Time frame: 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
Time frame: 3 months of wearing the Fitbit and completing the surveys

Results and safety

Results posted to the registry on 21 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	36	33
Just-in-time Adaptive Intervention (JITAI)	36	36

Primary outcome: Feasibility and Acceptability as Measured by the Percentage of Agree or Strongly Agree Responses to the Individual Items on the Feasibility Questionnaire

Time frame: 3 months of wearing the Fitbit and completing the surveys. Count of participants. Unit: Participants

Measure	All Participants, in a Whole Sample n = 69
Instructions for the Fitbit®️ were easy to understand.	62
The Fitbit® was easy to set up.	63
The Fitbit® was easy to use.	64
The Fitbit® was comfortable to wear.	60
The Fitbit® was easy to sync with my phone.	58
I was confident using the Fitbit®	59
The instructions for the CareQOL app set up were easy to understand.	66
The CareQOL app was easy to set up.	65

Population analysed: one participant did not complete this measure

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Three months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	0 of 34 (0%)	1 of 34 (2.9%)	0 of 34
Just-in-time Adaptive Intervention (JITAI)	0 of 36 (0%)	2 of 36 (5.6%)	0 of 36

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37707948Wang 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.
Derived from this study: PubMed 37358716Carlozzi 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.
Derived from this study: PubMed 36355640Carlozzi 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.
Derived from this study: PubMed 34889775Carlozzi 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.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Noelle Carlozzi, Ph.D principal investigator

University of Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Just-in-time adaptive intervention (JITAI) in people with Caregivers, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility and Acceptability as Measured by the Percentage of Agree or Strongly Agree Responses to the Individual Items on the Feasibility Questionnaire (time frame: 3 months of wearing the Fitbit and completing the surveys). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04556591, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.