Clinical trial · Interventional
mHealth Family Self-Management
mHealth Family Self-Management Intervention for Parents of Transplanted Children
NCT03533049CI-TRIAL-00045867myFAMIcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Transplantation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| myFAMI | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- myFAMI intervention
- 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.
- interventionNames
- Other: myFAMI
- type
- ACTIVE_COMPARATOR
- label
- Control
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 100 Years
Show eligibility criteria text
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. \-
References
Publications (1)
- DERIVEDLerret SM, Flynn E, White-Traut R, Alonso E, Mavis AM, Jensen MK, Peterson CG, Schiffman R. Acceptability of an mHealth Family Self-management Intervention (myFAMI) for Pediatric Transplantation Families: Qualitative Focus. JMIR Nurs. 2022 Jul 15;5(1):e39263. doi: 10.2196/39263. PMID 35838761