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

Cerebral Palsy Clinical Trial

— RE-PACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05292365
• Other study ID #: 2021-1532
• Secondary ID: R34HL153570-01A1
• Status: Completed
• Phase: N/A
• Start date: April 27, 2022
• Est. completion date: February 27, 2024

Study information

• Verified date: March 2024
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 27, 2024
• Est. primary completion date: February 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Behavioral:
• RE-PACT Intervention
Create respiratory illness action plan Weekly mHealth text messages Monthly study assessments Action planning and JIT coaching

Locations

Country	Name	City	State
United States	University of California	Los Angeles	California
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Family Caregiver Activation in Transition Measure (FCAT) - mean composite score	Capability is in part measured by the FCAT mean composite score,. FCAT is a 10-item survey to assess the caregiver's challenges on the day it is taken, scored on a 5 point likert scale from 1 (disagree strongly) to 5 (agree strongly).	up to 6 months
Other	Caregiver General Self-Efficacy Scale (GSES) - mean composite score	Capability is in part measured by the GSES mean composite score. GSES is a 10-item survey scored on a 4-point Likert scale from 1 (not true at all) to 4 (exactly true).	up to 6 months
Other	Family Experiences with Care Coordination (FECC) - percent top-box score for selected items	Opportunity is assessed via the FECC score, using measure specifications for each item(s).	up to 6 months
Other	Confidence Responses mHealth texting (weekly score 1 through 10)	Motivation is assessed by the confidence response to weekly texting (1-10 with higher scores indicating increased confidence).	up to 6 months
Primary	Feasibility: Number of days to meet target enrollment of 90 participants	Feasibility will in part be measured by the number of days to meet target enrollment of 90 participants.	up to 3 months
Primary	Feasibility: 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.	up to 3 months
Primary	Feasibility: Number of minutes logged for action planning and coaching activities	Feasibility will in part be measured by the amount of time it takes to deliver the intervention.	up to 6 months
Primary	Feasibility: 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.	up to 6 months
Primary	Feasibility: Incidence of Data Infrastructure	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.	up to 24 months
Primary	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.	up to 6 months
Primary	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.	up to 6 months
Primary	Acceptability: Participant Drop Out Rate	Acceptability will in part be measured by the participant drop out rate.	up to 6 months
Primary	Acceptability: Quantitative Participant Feedback Questions	Acceptability of the intervention will in part be measured by the participant feedback. Questions with binary Yes/No answers to be reported here include: 'Did you use the [action plan / coaching] this month?' and questions with binary 'Definitely/Probably' answers to the questions, 'How likely are you to recommend [action planning / texting and clinical response]to others?' and 'How much would you want these approaches to continue as a part of regular care after the study is done?'.	up to 6 months
Primary	Acceptability: Qualitative Participant Feedback Questions	Acceptability of the intervention will in part be measured by the participant feedback to better understand barriers and benefits. Qualitative questions including 'how could any of [the intervention - action planning, texting, coaching] be improved?' and 'Why would you recommend (or not recommend) this intervention to another family?' Participant feedback will be summarized thematically.	up to 6 months
Primary	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).	up to 6 months
Primary	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.	up to 6 months
Primary	Fidelity: Number of Respiratory and 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.	up to 6 months
Primary	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.	up to 6 months
Primary	Fidelity: Coaching Phone Call Success Rate by Intervention Trigger	Fidelity of the intervention will in part be measured by the coaching phone call success rate, which is the number of calls completed divided by the number of calls expected), stratified by trigger. The goal is over 80 percent.	up to 6 months
Primary	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).	up to 6 months
Primary	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.	up to 6 months
Primary	Fidelity: Data Collection Rate	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.	up to 6 months
Secondary	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.	up to 6 months
Secondary	Total Hospital Days During Severe Respiratory Illness		up to 6 months
Secondary	Number of Systemic Steroid Courses		up to 6 months
Secondary	Number of Systemic Antibiotic Courses		up to 6 months
Secondary	Number of Respiratory Emergency Department Visits		up to 6 months
Secondary	Child Mortality Rate		up to 6 months