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Behavioral Intervention

Health Coaching via Text Messaging for Cerebral Palsy (RE-PACT Trial)

N/A

Waitlist Available

Led By Ryan Coller, MD, MPH

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has a child aged 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)

Be at least 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

RE-PACT Trial Summary

This trial will test a new way to reduce respiratory illnesses in children with severe cerebral palsy, by using text messages to deliver timely, customized health coaching.

Who is the study for?

This trial is for primary caregivers of children aged 0-17 with severe cerebral palsy (GMFCS level IV or V), who are under respiratory specialist care or receive daily treatments. Caregivers must be adults, speak English or Spanish, and have a text-capable phone. Those not interested in text messaging or coaching are excluded.Check my eligibility

What is being tested?

The RE-PACT Intervention is being tested to see if it can reduce hospitalizations due to severe respiratory illness in children with severe CP by providing customized action plans and health coaching through mobile texts when the risk is high.See study design

What are the potential side effects?

Since RE-PACT involves non-medical interventions like action planning and health coaching via text messages, there are no direct medical side effects associated with this study.

RE-PACT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My child with severe cerebral palsy receives daily respiratory care.

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I am 18 years old or older.

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I can communicate well in English or Spanish.

RE-PACT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability: Categorized Reasons for Consent Refusal

Acceptability: Participant Drop Out Rate

Acceptability: Participant Enrollment Rate

+15 more

Secondary outcome measures

Child Mortality Rate

Incidence of Respiratory Diagnosis Requiring Hospitalization

Number of Respiratory Emergency Department Visits

+3 more

Other outcome measures

Caregiver General Self-Efficacy Scale (GSES) - mean composite score

Confidence Responses mHealth texting (weekly score 1 through 10)

Family Caregiver Activation in Transition Measure (FCAT) - mean composite score

+1 more

RE-PACT Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: RE-PACT InterventionExperimental Treatment1 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 II: Active Control (AC)Active Control1 Intervention

AC subjects will receive usual comprehensive medical care and coordination.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

RE-PACT Intervention

2022

N/A

~60

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor

1,182 Previous Clinical Trials

3,167,327 Total Patients Enrolled

1 Trials studying Cerebral Palsy

10 Patients Enrolled for Cerebral Palsy

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,835 Previous Clinical Trials

47,310,610 Total Patients Enrolled

Ryan Coller, MD, MPHPrincipal InvestigatorUW School of Medicine and Public Health

3 Previous Clinical Trials

426 Total Patients Enrolled

Media Library

RE-PACT Intervention (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05292365 — N/A

Cerebral Palsy Research Study Groups: RE-PACT Intervention, Active Control (AC)

Cerebral Palsy Clinical Trial 2023: RE-PACT Intervention Highlights & Side Effects. Trial Name: NCT05292365 — N/A

RE-PACT Intervention (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05292365 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for people to participate in this trial?

"Affirmative. Data accessible on clinicaltrials.gov indicates that this research endeavour, which was initially published on April 27th 2022, is still recruiting participants. Approximately 90 individuals must be sourced from 2 different medical institutions."

Answered by AI

What is the current capacity of participants for this experiment?

"Affirmative. Clinicaltrials.gov attests to the ongoing recruitment of participants for this clinical trial, which was first posted on April 27th 2022 and recently updated on August 18th 2022. This research is in search of 90 individuals across two medical centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Respiratory Exacerbation Plans for Action and Care Transitions for Children With Severe CP". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05292365.