mHealth Family Self-Management

Not Applicable

Completed

• Conditions: Transplantation; Pediatric ALL

• Registration Number: NCT03533049
• Lead Sponsor: Medical College of Wisconsin

Brief Summary

This innovative research will address a gap in the literature involving the evaluation of the impact of an individualized family-centered mHealth application to enhance daily post-discharge communication following pediatric transplant. This proposal lays the foundation for future research with myFAMI (self-management intervention) at multiple pediatric transplant centers and builds the science from which to consider post discharge monitoring and decrease cost of care in other pediatric chronic illness populations.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-25
• Study First Submitted QC: 2018-05-10
• Study First Posted: 2018-05-22
• Study Start: 2018-10-01
• Primary Completion: 2020-04-01
• Study Completion: 2020-05-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-08
• Last Update Posted: 2020-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

Pediatric patients:

1. Has undergone a heart, kidney, or liver transplant being discharged home from the hospital
2. Has two eligible family members available to answer questions about the patient

Family members will be eligible for participation upon meeting the following inclusion criteria:

1. is English speaking (to date the instruments being used have been validated for English speaking participants only)
2. is 18 years of age or older
3. has a pediatric family member (< 18 years old) who has undergone a heart, kidney, or liver transplant being discharged home from the hospital.

Exclusion Criteria for the family members are:

1. presence of significant communication or cognitive impairment that would preclude completion of questionnaires based on self-report; or
2. the pediatric family member has experienced a previous transplant based on self report.

Participants unable to speak and read English will be excluded due to the lack of resources to develop the app and communicate via FaceTime in different languages. We will recruit family members from three types of transplant populations to allow for sufficient sample in a limited time frame for this complex pediatric surgery and high-risk population.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Improve family coping	30 days	Primary family member receiving myFAMI compared to the primary family member receiving standard post-discharge care will have improved post-discharge coping (primary outcome). Coping will be measured using the post-discharge coping difficulty scale. Post Discharge Coping Difficulty Scale (PDCDS), 10-item measure, Scale 0-10, Measures parental and family member difficulty coping with stress, recovery, self-care and management, support, and confidence, α= .84

Secondary Outcome Measures

Name	Time	Method
Decrease healthcare resources	30 days	Primary family member receiving myFAMI compared to the primary family member receiving standard post-discharge care will have decreased use of healthcare resources defined as number of emergency department visits and number or readmissions to the hospital.

Trial Locations

Locations (1)

Children's Hospital of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States