mHealth Family Self-Management

Pediatric ALL Clinical Trial

— myFAMI  

Official title:

mHealth Family Self-Management Intervention for Parents of Transplanted Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03533049
• Other study ID #: 1183697
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: May 1, 2020

Study information

• Verified date: July 2020
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: May 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 100 Years

Eligibility

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.

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Related Conditions & MeSH terms

• Pediatric ALL
• Transplantation

Intervention

Other:
• myFAMI
Patients who are assigned to the myFAMI group will also have the smartphone application downloaded onto either the family member's smartphone or a study-provided smartphone. Following discharge from the hospital, participants will use the smartphone application to answer nine daily questions regarding tracking family coping, transplant symptoms, family management of child transplant symptoms, and family-management difficulty with medication and follow-up regimen daily for the first 30 days following discharge.

Locations

Country	Name	City	State
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improve family coping	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, a= .84	30 days
Secondary	Decrease healthcare resources	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.	30 days