MedDataX Logo

Respiratory Exacerbation Plans for Action and Care Transitions for Children With Severe CP

NCT ID: NCT05292365

Last Updated: 2024-12-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-27

Study Completion Date

2024-02-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will pilot test a just-in-time (JIT) adaptive intervention to reduce severe respiratory illness, for children with severe cerebral palsy (CP). The intervention program, called RE-PACT, delivers timely, customized action planning and health coaching when mobile text messaging with families predicts hospitalization risk is elevated. A total of n=90 caregivers of children with severe CP will be enrolled from the University of Wisconsin-Madison (UW) and the University of California, Los Angeles (UCLA) and can expect to be on study for up to 6 months.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The two-site study takes place at clinical programs at US children's hospitals: the UW and UCLA Pediatric Complex Care Pro-grams were each established to deliver care to children with medical complexity. Each program is comprised of primary care providers, care coordinators, and extended visit lengths, deliver comprehensive care to children with cerebral palsy. These sites have existing collaborative relationships through their participation in the CYSHCNet national research network (http://cyshcnet.org) and other federally funded initiatives, and a track record of successful productive scientific collaboration.

The study period will be divided into three waves: after each wave, feasibility, acceptability, and fidelity data will be reviewed against pre-defined measures of success to adjust the protocol and overcome implementation barriers.

This study will be conducted through a six-month randomized pilot trial. Briefly, after recruitment and baseline assessments, eligible caregiver/child dyads are randomized to intervention (I) or active control (AC). Intervention subjects receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted. AC subjects will receive usual comprehensive medical care and coordination. Assessments of feasibility, acceptability and fidelity, as well as clinical outcomes, will be conducted at baseline and monthly intervals for 6 months. Intervention outcomes will be evaluated at baseline (i.e., randomization) and 6 months post-enrollment, and will also include the primary clinical outcome (i.e., hospitalization for respiratory diagnosis).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cerebral Palsy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

caregiver support

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

eligible caregiver/child dyads are randomized to intervention or active control
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

RE-PACT Intervention

Intervention participants receive respiratory illness action plans and weekly mobile health (mHealth) confidence surveillance. At times of low confidence or hospitalization, just-in-time action planning and coaching activities are conducted.

Group Type EXPERIMENTAL

RE-PACT Intervention

Intervention Type BEHAVIORAL

* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching

Active Control (AC)

AC subjects will receive usual comprehensive medical care and coordination.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

RE-PACT Intervention

* Create respiratory illness action plan
* Weekly mHealth text messages
* Monthly study assessments
* Action planning and JIT coaching

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Be at least 18 years of age
* Primary caregiver to an eligible child (child criteria below)
* Speak English or Spanish well enough to be interviewed
* Have a phone capable of sending/receiving text messages
* Has a child

* age 0-17 years
* with Gross Motor Function Classification System level IV or V Cerebral Palsy
* Cared for by respiratory specialist or receive daily respiratory treatments (oxygen, ventilation, airway clearance device, medications)

Exclusion Criteria

* Lack of interest in text messaging or coaching interactions during the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ryan Coller, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

UW School of Medicine and Public Health

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of California

Los Angeles, California, United States

Site Status

University of Wisconsin

Madison, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Coller RJ, Singh-Verdeflor K, Eickhoff J, Chung PJ, Kloster HM, Cushing CC, Gerber DM, Katz BJ, Ia S, Wagner T, Delgado-Martinez R, Warner G, Porras-Javier L, Klitzner TS, Lerner CF. Preventing respiratory illness in cerebral palsy: Results of a pilot randomized controlled trial. PLoS One. 2025 Jun 16;20(6):e0325970. doi: 10.1371/journal.pone.0325970. eCollection 2025.

Reference Type DERIVED
PMID: 40522978 (View on PubMed)

Fleischman A, Lerner C, Kloster H, Chung P, Klitzner T, Cushing C, Gerber D, Katz B, Warner G, Singh-Verdeflor KD, Delgado-Martinez R, Porras-Javier L, Ia S, Wagner T, Ehlenbach M, Coller R. Adaptive Intervention to Prevent Respiratory Illness in Cerebral Palsy: Protocol for a Feasibility Pilot Randomized Controlled Trial. JMIR Res Protoc. 2024 Jan 8;13:e49705. doi: 10.2196/49705.

Reference Type DERIVED
PMID: 38190242 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R34HL153570-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A536771

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 2/24/2023

Identifier Type: OTHER

Identifier Source: secondary_id

2021-1532

Identifier Type: -

Identifier Source: org_study_id