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Cerebral PalsyRE-PACTNCT05292365

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

A study testing RE-PACT Intervention in people with Cerebral Palsy, run by University of Wisconsin, Madison at 2 sites 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

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cerebral Palsy
What is being tested?
RE-PACT Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesUnited States
Study dates
27 Apr 2022to 27 Feb 2024
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • Lack of interest in text messaging or coaching interactions during the study

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of California

    Los Angeles, California, 90095

  • University of Wisconsin

    Madison, Wisconsin, 53792

Other trials in United States

About this study

Official title: Respiratory Exacerbation Plans for Action and Care Transitions for Children With Severe Cerebral Palsy (CP)

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.

Read the detailed description

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
Cerebral Palsy
Being tested
RE-PACT Intervention
Keywords
caregiver, support
Medical subject headings
Cerebral Palsy

What participants receive

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

  • RE-PACT InterventionBehavioural

    • Create respiratory illness action plan
    • Weekly mHealth text messages
    • Monthly study assessments
    • Action planning and JIT coaching
Study groups in NCT05292365
Study groupRoleWhat they receive
RE-PACT InterventionExperimentalIntervention 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.
Receives: Behavioral: RE-PACT Intervention
Active Control (AC)No interventionAC subjects will receive usual comprehensive medical care and coordination.

What is being measured

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

  1. Feasibility: Number of Days to Meet Target Enrollment Size

    Feasibility will, in part, be measured by the number of days to meet target enrollment by wave. There are a total of 3 recruitment waves.

    This Outcome Measure was assessed by child.

    Measured: up to 3 months

  2. Feasibility: Median Number of Days Between Randomization and Intervention Activities

    Feasibility will, in part, be measured by the number of days between randomization and (time zero) intervention activities.

    This Outcome Measure was assessed by child.

    Measured: up to 3 months

  3. Feasibility: Mean Number of Minutes Logged for Action Planning

    Feasibility will, in part, be measured by the amount of time it takes to deliver the intervention.

    This Outcome Measure was assessed by child.

    Measured: up to 6 months

  4. Feasibility: Mean Number of Minutes Logged for Clinical Response / Coaching

    Feasibility will, in part, be measured by the amount of time it takes to deliver the intervention.

    This Outcome Measure was assessed by child.

    Measured: up to 6 months

  5. Feasibility: Mean Number of Intervention Triggers Per Patient

    Feasibility will, in part, be measured by the number of intervention triggers per patient (annualized), including respiratory and non-respiratory triggers.

    This Outcome Measure was assessed by child.

    Measured: up to 6 months

  6. Feasibility: Incidence of Data Infrastructure Issues

    Feasibility will in part be measured by the presence of necessary data infrastructure issues. This is a measure of the presence of complete data collection, between 2 sites, data use agreements and Institutional Review Board reliance. This outcome includes any events that occur over the study duration.

    Measured: up to 22 months

  7. Acceptability: Participant Enrollment Rate

    Acceptability will in part be measured by the participant enrollment rate, or the number of participants enrolled divided by the number of participants approached + potentially eligible.

    This Outcome Measure was assessed by child.

    Measured: up to 6 months

  8. Acceptability: Categorized Reasons for Consent Refusal

    Acceptability will in part be assessed by collecting potential participants reason for not consenting to the study. Reasons will be summarized in tabular form.

    This Outcome Measure was assessed in caregivers.

    Measured: up to 6 months

  9. Acceptability: Participant Drop Out Rate

    Acceptability will in part be measured by the participant drop out rate.

    This Outcome Measure was assessed by child.

    Measured: up to 6 months

  10. Acceptability: Measured by Mean Number of Months Participants Reported Using Action Plan

    Acceptability of the intervention will in part be measured by the participant feedback.

    • The number of months, on average, where participants reported use of an action plan.

    This Outcome Measure was assessed by dyad.

    Measured: up to 6 months

  11. Acceptability: Measured by Number of Participants Reporting Definite or Probably About Recommendation of Action Plan to Others

    Acceptability of the intervention will in part be measured by the participant feedback.

    • Number of participants reporting definite or probably recommendation of action planning to others.

    This Outcome Measure was assessed by dyad.

    Measured: up to 6 months

  12. Acceptability: Measured by Number of Participants Reporting Definite or Probably About Recommendation of Texting and Clinical Response to Others

    Acceptability of the intervention will in part be measured by the participant feedback.

    • Number of participants reporting definite or probably recommendation of texting and clinical response to others.

    This Outcome Measure was assessed in dyads.

    Measured: up to 6 months

  13. Acceptability: Measured by Number of Participants Reporting Definite or Probably About Whether to Continue Intervention After Study is Done

    Acceptability of the intervention will in part be measured by the participant feedback.

    • 'How much would you want these approaches to continue as a part of regular care after the study is done?'.

    This Outcome Measure was assessed in dyads.

    Measured: up to 6 months

  14. Acceptability: System Usability Scale - Composite Score

    Acceptability of the intervention will in part be measured by composite score. The System Usability Scale is a 10-item survey scored on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate higher usability. Score range = 0 - 100.

    This Outcome Measure was assessed in dyads.

    To calculate the score:

    Step 1: Convert the scale into number for each of the 10 questions Strongly Disagree: 1 point Disagree: 2 points Neutral: 3 points Agree: 4 points Strongly Agree: 5 points

    Step 2: Calculate X = Sum of the points for all odd-numbered questions - 5 Y = 25 - Sum of the points for all even-numbered questions SUS Score = (X + Y) x 2.5

    Measured: up to 6 months

  15. Fidelity: Time of Participant Enrollment in the Study

    Fidelity of the intervention will in part be measured by the amount of time (in months) the participant was enrolled in the study. The target participation time is 6 months.

    This Outcome Measure was assessed in children.

    Measured: up to 6 months

  16. Fidelity: Number of Respiratory Action Plans Per Patient

    Fidelity of the intervention will in part be measured by the number of respiratory and overall action plans per patient. The goal is greater than or equal to 1.

    This Outcome Measure was assessed in children.

    Measured: up to 6 months

  17. Fidelity: Number of Overall Action Plans Per Patient

    Fidelity of the intervention will in part be measured by the number of respiratory and overall action plans per patient. The goal is greater than or equal to 1.

    This Outcome Measure was assessed in children.

    Measured: up to 6 months

  18. Fidelity: Coaching Visit Success Rate by Intervention Trigger

    Fidelity of the intervention will in part be measured by the coaching visit success rate, which is the number of visits (at home or virtually) completed divided by the number of visits expected), stratified by trigger. The goal is over 80 percent.

    This Outcome Measure was assessed in children.

    Measured: up to 6 months

  19. Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Caregiver Reported Confidence < 5

    Fidelity of the intervention will in part be measured by the coaching phone call completion rate, which is the number of calls completed divided by the number of calls expected), stratified by trigger. The goal is over 80 percent.

    This Outcome Measure was assessed in children.

    Measured: up to 6 months

  20. Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Hospital Discharge

    Fidelity of the intervention will in part be measured by the coaching phone call completion rate, which is the number of calls completed divided by the number of calls expected), stratified by trigger. The goal is over 80 percent.

    This Outcome Measure was assessed in children.

    Measured: up to 6 months

  21. Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Caregiver Calls or Messages Complex Care Team

    Fidelity of the intervention will in part be measured by the coaching phone call completion rate, which is the number of calls completed divided by the number of calls expected), stratified by trigger. The goal is over 80 percent.

    This Outcome Measure was assessed in children.

    Measured: up to 6 months

  22. Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Multiple Triggers

    Fidelity of the intervention will in part be measured by the coaching phone call completion rate, which is the number of calls completed divided by the number of calls expected), stratified by trigger. The goal is over 80 percent.

    This Outcome Measure was assessed in children.

    Measured: up to 6 months

  23. Fidelity: Text Message Response Rate

    Fidelity of the intervention will in part be measured by the response rate to mHealth text messages, which is the number of texts responded divided by the number of texts expected.

    This Outcome Measure was assessed in dyads.

    Measured: up to 6 months

  24. Fidelity: Number of Participants Inappropriately Receiving Intervention

    Fidelity of the intervention will in part be measured by cross-over, which is the number of participants inappropriately receiving the intervention component.

    This Outcome Measure was assessed in children.

    Measured: up to 6 months

  25. Fidelity: Data Collection Rate: Enrollment Surveys

    Fidelity of the intervention will in part be measured by the data collection rate, which is the number of data collection events complete divided by the number of total data collections events possible.

    This Outcome Measure was assessed in dyads.

    Measured: Baseline to 2 months

  26. Fidelity: Data Collection Rate: Monthly Surveys

    Fidelity of the intervention will in part be measured by the data collection rate, which is the number of data collection events complete divided by the number of total data collections events possible.

    This Outcome Measure was assessed in dyads.

    Measured: up to 6 months

  27. Fidelity: Data Collection Rate: Exit Surveys

    Fidelity of the intervention will in part be measured by the data collection rate, which is the number of data collection events complete divided by the number of total data collections events possible.

    This Outcome Measure was assessed in dyads.

    Measured: up to 6 months

Secondary outcomes (6)

  1. Incidence of Respiratory Diagnosis Requiring Hospitalization

    Severe respiratory illness, defined as respiratory diagnoses requiring hospitalization. Respiratory diagnoses includes discharge diagnosis of any of the following: asthma, pneumonia (community or hospital acquired), bronchiolitis, influenza, upper or lower respiratory tract infection, tracheitis, aspiration pneumonia/pneumonitis, chronic lung disease, respiratory failure.

    • Number of children with at least 1 severe respiratory illness

    Measured: up to 6 months

  2. Total Hospital Days During Severe Respiratory Illness by Arm

    Hospital days were summed by arm.

    Measured: up to 6 months

  3. Number of Systemic Steroid Courses

    Measured: up to 6 months

  4. Number of Systemic Antibiotic Courses

    Measured: up to 6 months

  5. Number of Respiratory Emergency Department Visits

    Measured: up to 6 months

  6. Child Mortality Rate

    Measured: up to 6 months

Timeline

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

  1. First posted23 Mar 2022
  2. Study start27 Apr 2022
  3. Primary completion27 Feb 2024
  4. Study completion27 Feb 2024

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
eligible caregiver/child dyads are randomized to intervention or active control
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05292365
Sponsor's protocol ID
2021-1532
Other IDs
R34HL153570-01A1, A536771, Protocol Version 2/24/2023
Acronym
RE-PACT
Status last verified
Nov 2024
First submitted
14 Mar 2022
Last updated
19 Dec 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The investigators will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. Data prepared for distribution under a data-use agreement will be redacted to ensure privacy of study participant identity. The data-use agreement will include requirements to protect participants' privacy and data confidentiality. It will prohibit the recipient from transferring the data to other users and require that the data's security be protected by standard means and be used for research purposes only.

Publications

  • 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.

    PubMed 40522978

  • 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.

    PubMed 38190242

Questions about this trial

What is this clinical trial studying?

A study testing RE-PACT Intervention in people with Cerebral Palsy, run by University of Wisconsin, Madison at 2 sites 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 8 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 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 19 Dec 2024). 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: Number of Days to Meet Target Enrollment Size (time frame: up to 3 months). The study lists 27 primary outcomes in all. 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 NCT05292365, which also lists 2 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 19 Dec 2024.

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