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

NCT05292365 | Completed Results DMC

• 4 other identifiers: 2021-1532R34HL153570-01A1A536771Protocol Version 2/24/2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Cerebral Palsy

Keywords

caregiver; support

Outcome Measures

Primary Outcomes (27)

• 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.

  up to 3 months

• 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.

  up to 3 months

• 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.

  up to 6 months

• 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.

  up to 6 months

• 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.

  up to 6 months

• 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.

  up to 22 months

• 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.

  up to 6 months

• 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.

  up to 6 months

• Acceptability: Participant Drop Out Rate

  Acceptability will in part be measured by the participant drop out rate. This Outcome Measure was assessed by child.

  up to 6 months

• 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.

  up to 6 months

• 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.

  up to 6 months

• 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.

  up to 6 months

• 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.

  up to 6 months

• 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

  up to 6 months

• 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.

  up to 6 months

• 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.

  up to 6 months

• 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.

  up to 6 months

• 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.

  up to 6 months

• 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.

  up to 6 months

• 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.

  up to 6 months

• 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.

  up to 6 months

• 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.

  up to 6 months

• 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.

  up to 6 months

• 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.

  up to 6 months

• 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.

  Baseline to 2 months

• 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.

  up to 6 months

• 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.

  up to 6 months

Secondary Outcomes (6)

• Incidence of Respiratory Diagnosis Requiring Hospitalization

  up to 6 months

• Total Hospital Days During Severe Respiratory Illness by Arm

  up to 6 months

• Number of Systemic Steroid Courses

  up to 6 months

• Number of Systemic Antibiotic Courses

  up to 6 months

• Number of Respiratory Emergency Department Visits

  up to 6 months

Other Outcomes (4)

• Family Caregiver Activation in Transition Measure (FCAT) - Mean Composite Score

  up to 6 months

• Caregiver General Self-Efficacy Scale (GSES) - Sum Composite Score

  up to 6 months

• Family Experiences With Care Coordination (FECC): Care Coordination Question Set

  up to 6 months

Study Arms (2)

RE-PACT Intervention

EXPERIMENTAL

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.

Behavioral: RE-PACT Intervention

Active Control (AC)

NO INTERVENTION

AC subjects will receive usual comprehensive medical care and coordination.

Interventions

RE-PACT Intervention BEHAVIORAL

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

RE-PACT Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

University of California

Los Angeles, California, 90095, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Related Publications (2)

• 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.

  PMID: 40522978 DERIVED

• 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.

  PMID: 38190242 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Dr. Ryan Coller
• Organization: University of Wisconsin School of Medicine and Public Health

rcoller@pediatrics.wisc.edu

608-263-9408

Study Officials

• Ryan Coller, MD, MPH

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: eligible caregiver/child dyads are randomized to intervention or active control

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: March 23, 2022
• Study Start: April 27, 2022
• Primary Completion: February 27, 2024
• Study Completion: February 27, 2024
• Last Updated: December 19, 2024
• Results First Posted: December 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data from this study may be requested from other researchers after the completion of the primary endpoint analyses by contacting the study PI.
• Access Criteria: The method of distribution will be by request to the study PI. After review and approval, a requestor completes the data-sharing agreement, requestor will receive a limited dataset mailed by CD or emailed through UW-Madison secured email systems that require users to create an account and sign-in with a username and password in order to receive and download any type of sensitive data.

Locations

US (2)