Evidence map›Paper›PMID 34889775›Full record

ArticleJMIR research protocols2021

An App-Based Just-in-Time Adaptive Self-management Intervention for Care Partners (CareQOL): Protocol for a Pilot Trial.

Noelle E Carlozzi, Sung Won Choi, Zhenke Wu, Jennifer A Miner, Angela K Lyden, Christopher Graves, Jitao Wang, Srijan Sen

Registry-linked trialAbstract read
In one paragraph

Article in JMIR research protocols, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04556591 (Mobile Technology and Data Analytics to Identify Real-time Predictors of Caregiver Well-Being), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04556591 nacompletednot on this map

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

TypeinterventionalSponsorUniversity of MichiganRan2020 to 2021Enrolled72ConditionsCaregiversArmsJust-in-time adaptive intervention (JITAI), Control
3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

  1. Trial
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Noelle E CarlozziDepartment of Physical Medicine and Rehabilitation, University of Michigan, Ann Arbor, MI, United States.ORCID https://orcid.org/0000-0003-0439-9429
Sung Won ChoiDepartment of Pediatrics, University of Michigan, Ann Arbor, MI, United States.ORCID https://orcid.org/0000-0002-6321-3834
Zhenke WuDepartment of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, MI, United States.ORCID https://orcid.org/0000-0001-7582-669X
Jennifer A MinerDepartment of Physical Medicine and Rehabilitation, University of Michigan, Ann Arbor, MI, United States.ORCID https://orcid.org/0000-0003-2722-1121
Angela K LydenClinical Trials Support Office, University of Michigan, Ann Arbor, MI, United States.ORCID https://orcid.org/0000-0003-0964-1667
Christopher GravesDepartment of Physical Medicine and Rehabilitation, University of Michigan, Ann Arbor, MI, United States.ORCID https://orcid.org/0000-0002-8862-0508
Jitao WangDepartment of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, MI, United States.ORCID https://orcid.org/0000-0003-4011-3352
Srijan SenDepartment of Psychiatry, University of Michigan, Ann Arbor, MI, United States.ORCID https://orcid.org/0000-0003-4495-495X

Funding

Michigan Institute for Clinical and Health Research (MICHR)UL1TR002240 · NCATS · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI LUMENG, JULIE C, MASHOUR, GEORGE ALEXANDER · 2017 to 2022
$54.9M
Quality of Life in Caregivers of Traumatic Brain Injury: The TBI-CareQOLR01NR013658 · NINR · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI CARLOZZI, NOELLE E. · 2012 to 2024
$6.0M
Roadmap 2.0: A randomized controlled trial using a technology-mediated platform in family caregivers of BMT patientsR01HL146354 · NHLBI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI CHOI, SUNG WON · 2019 to 2023
$1.8M
NCATS NIH HHS UL1 TR002240NHLBI NIH HHS R01 HL146354NINR NIH HHS R01 NR013658
6 · The paper itself

Abstract

backgroundCare partners (ie, informal family caregivers) of individuals with health problems face considerable physical and emotional stress, often with a substantial negative impact on the health-related quality of life (HRQOL) of both care partners and care recipients. Given that these individuals are often overwhelmed by their caregiving responsibilities, low-burden self-management interventions are needed to support care partners to ensure better patient outcomes.

objectiveThe primary objective of this study is to describe an intensive data collection protocol that involves the delivery of a personalized just-in-time adaptive intervention that incorporates passive mobile sensor data feedback (sleep and activity data from a Fitbit [Fitbit LLC]) and real time self-reporting of HRQOL via a study-specific app called CareQOL (University of Michigan) to provide personalized feedback via app alerts.

methodsParticipants from 3 diverse care partner groups will be enrolled (care partners of persons with spinal cord injury, care partners of persons with Huntington disease, and care partners of persons with hematopoietic cell transplantation). Participants will be randomized to either a control group, where they will wear the Fitbit and provide daily reports of HRQOL over a 3-month (ie, 90 days) period (without personalized feedback), or the just-in-time adaptive intervention group, where they will wear the Fitbit, provide daily reports of HRQOL, and receive personalized push notifications for 3 months. At the end of the study, participants will complete a feasibility and acceptability questionnaire, and metrics regarding adherence and attrition will be calculated.

resultsThis trial opened for recruitment in November 2020. Data collection was completed in June 2021, and the primary results are expected to be published in 2022.

conclusionsThis trial will determine the feasibility and acceptability of an intensive app-based intervention in 3 distinct care partner groups: care partners for persons with a chronic condition that was caused by a traumatic event (ie, spinal cord injury); care partners for persons with a progressive, fatal neurodegenerative disease (ie, Huntington disease); and care partners for persons with episodic cancer conditions that require intense, prolonged inpatient and outpatient treatment (persons with hematopoietic cell transplantation).

trial registrationClinicalTrials.gov NCT04556591; https://clinicaltrials.gov/ct2/show/NCT04556591. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/32842.

Indexed as

caregiversfeasibility studieshematopoietic stem cell transplantationHuntington diseasemobile appsmobile phoneoutcome assessmentquality of lifeself-managementspinal cord injuries

Identifiers

PMID34889775
PMCPMC8704108

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.