mHealth Family Self-Management (myFAMI)

Medical College of Wisconsin

Status: Completed

Conditions: Pediatric ALL; Transplantation

Treatments: Other: myFAMI

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03533049

1183697

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: All

Ages: Under 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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67 participants in 2 patient groups

myFAMI intervention

Experimental group

Description:

All participants will receive the standard discharge education from their transplant and inpatient care team. 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.

Treatment:

Other: myFAMI

Control

Active Comparator group

Description:

Family members assigned to the control group (standard care) will receive standard post-discharge follow-up care consisting of discharge education during the transplant hospitalization and at regularly scheduled appointments instructing families to contact the research nurse with problems or questions.

Treatment:

Other: myFAMI