N/A N=119 Randomized Supportive Care

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

Cerebral Palsy

Bottom Line

View on ClinicalTrials.gov: NCT05292365 ↗

Enrolled (actual)

119

Serious AEs

1.7%

Results posted

Dec 2024

Primary outcome: Primary: Feasibility: Number of Days to Meet Target Enrollment Size — 56; 29; 129 Days

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: RE-PACT Intervention (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Wisconsin, Madison
Primary completion: Feb 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Feasibility: Number of Days to Meet Target Enrollment Size	56; 29; 129	—
PRIMARY Feasibility: Median Number of Days Between Randomization and Intervention Activities	4	—
PRIMARY Feasibility: Mean Number of Minutes Logged for Action Planning	22.8	—
PRIMARY Feasibility: Mean Number of Minutes Logged for Clinical Response / Coaching	86.8	—
PRIMARY Feasibility: Mean Number of Intervention Triggers Per Patient	0.7	—
PRIMARY Feasibility: Incidence of Data Infrastructure Issues	0; 0; 0	—
PRIMARY Acceptability: Participant Enrollment Rate	60	—
PRIMARY Acceptability: Categorized Reasons for Consent Refusal	9; 10; 16; 6; 1; 2	—
PRIMARY Acceptability: Participant Drop Out Rate	35; 24; 1; 0	—
PRIMARY Acceptability: Measured by Mean Number of Months Participants Reported Using Action Plan	1.6	—
PRIMARY Acceptability: Measured by Number of Participants Reporting Definite or Probably About Recommendation of Action Plan to Others	25; 10	—
PRIMARY Acceptability: Measured by Number of Participants Reporting Definite or Probably About Recommendation of Texting and Clinical Response to Others	27; 8	—
PRIMARY Acceptability: Measured by Number of Participants Reporting Definite or Probably About Whether to Continue Intervention After Study is Done	23; 12	—
PRIMARY Acceptability: System Usability Scale - Composite Score	79.5	—
PRIMARY Fidelity: Time of Participant Enrollment in the Study	5.9; 6	—
PRIMARY Fidelity: Number of Respiratory Action Plans Per Patient	1	—
PRIMARY Fidelity: Number of Overall Action Plans Per Patient	1	—
PRIMARY Fidelity: Coaching Visit Success Rate by Intervention Trigger	9; 0; 9; 0; 4; 0	—
PRIMARY Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Caregiver Reported Confidence < 5	20; 18	—
PRIMARY Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Hospital Discharge	30; 18	—
PRIMARY Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Caregiver Calls or Messages Complex Care Team	9; 8	—
PRIMARY Fidelity: Coaching Phone Call Success Rate by Intervention Trigger - Multiple Triggers	10; 8	—
PRIMARY Fidelity: Text Message Response Rate	867; 889	—
PRIMARY Fidelity: Number of Participants Inappropriately Receiving Intervention	0; 0	—
PRIMARY Fidelity: Data Collection Rate: Enrollment Surveys	59	—
PRIMARY Fidelity: Data Collection Rate: Monthly Surveys	210	—
PRIMARY Fidelity: Data Collection Rate: Exit Surveys	55	—
SECONDARY Incidence of Respiratory Diagnosis Requiring Hospitalization	8; 11; 18; 13	—
SECONDARY Total Hospital Days During Severe Respiratory Illness by Arm	8; 32	—
SECONDARY Number of Systemic Steroid Courses	3; 3; 23; 21	—
SECONDARY Number of Systemic Antibiotic Courses	5; 6; 21; 18	—
SECONDARY Number of Respiratory Emergency Department Visits	0; 3	—
SECONDARY Child Mortality Rate	0; 0; 26; 24	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05292365). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.