What side effects are associated with this type of intervention?

Common treatments for cerebral palsy (CP) include physical and occupational therapy, pharmacologic interventions, and surgical options. Physical and occupational therapy generally have minimal side effects but can sometimes cause temporary discomfort or fatigue. Pharmacologic treatments, such as muscle relaxants (e.g., baclofen) and antispasticity medications (e.g., botulinum toxin), can cause side effects like drowsiness, weakness, and in rare cases, allergic reactions. Surgical interventions, including orthopedic surgeries and selective dorsal rhizotomy, carry risks such as infection, bleeding, and complications from anesthesia. The RE-PACT trial focuses on reducing severe respiratory illness through timely, customized action planning and health coaching, which primarily aims to mitigate hospitalization risk without direct pharmacologic or surgical interventions, thus minimizing the risk of side effects.

What prior FDA approvals exist?

The FDA has approved several pharmacologic treatments for managing symptoms of Cerebral Palsy, particularly spasticity. These include oral antispasticity medications like baclofen and benzodiazepines, as well as botulinum toxin injections for localized spasticity. Intrathecal baclofen pumps are also approved for severe cases. While the RE-PACT trial's approach using mobile text messaging for adaptive intervention is innovative, it does not directly align with specific FDA-approved pharmacologic treatments but represents a novel method to enhance existing care strategies by predicting and mitigating hospitalization risks.

What other types of research exist?

Promising alternatives to RE-PACT for CP patients include: 1) Technology-aided programs using tablets and applications like WhatsApp and MacroDroid to support independent leisure and communication. 2) Telemedicine-based interventions for remote monitoring and management of health conditions, which can provide timely support and reduce the need for hospital visits. 3) Intensive, integrated therapy programs combining occupational, physical, and speech therapy tailored to individual needs, which can be delivered both in-person and via telehealth platforms.

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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

No Placebo-Only Group

Summary

This trial tests a program called RE-PACT that sends personalized health advice via text messages to families of children with severe cerebral palsy. It aims to reduce hospital visits by providing timely support when the child's health is at risk. The study involves 90 caregivers and will last for several months.

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.

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability: Categorized Reasons for Consent Refusal

Acceptability: Participant Drop Out Rate

Acceptability: Participant Enrollment Rate

+15 more

Secondary study objectives

Incidence of Respiratory Diagnosis Requiring Hospitalization

Other study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Cerebral Palsy (CP) include physical and occupational therapy, pharmacologic interventions, and surgical options. Physical and occupational therapy aim to improve motor function and daily living skills through targeted exercises and activities. Pharmacologic treatments, such as muscle relaxants and botulinum toxin injections, help manage spasticity and dystonia by reducing muscle tone and preventing muscle contractures. Surgical interventions, like selective dorsal rhizotomy, address severe spasticity by cutting nerve roots to reduce muscle stiffness. The RE-PACT trial's just-in-time adaptive intervention, which uses mobile text messaging for timely action planning and health coaching, highlights the importance of personalized and proactive care in managing CP. This approach can help mitigate hospitalization risks by addressing health issues promptly and tailoring interventions to individual needs, thereby improving overall quality of life for CP patients.