mHealth Family Self-Management

NCT03533049 | Completed

• 1 other identifier: 1183697
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Transplantation; Pediatric ALL

Outcome Measures

Primary Outcomes (1)

• 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, α= .84

  30 days

Secondary Outcomes (1)

• Decrease healthcare resources

  30 days

Study Arms (2)

myFAMI intervention

EXPERIMENTAL

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.

Other: myFAMI

Control

ACTIVE COMPARATOR

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.

Other: myFAMI

Interventions

myFAMI OTHER

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.

Control; myFAMI intervention

Eligibility Criteria

• Age: Up to 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pediatric patients:
• Has undergone a heart, kidney, or liver transplant being discharged home from the hospital
• Has two eligible family members available to answer questions about the patient
• is English speaking (to date the instruments being used have been validated for English speaking participants only)
• is 18 years of age or older
• has a pediatric family member (\< 18 years old) who has undergone a heart, kidney, or liver transplant being discharged home from the hospital.

You may not qualify if:

• presence of significant communication or cognitive impairment that would preclude completion of questionnaires based on self-report; or
• 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.

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

• Lerret 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 DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Stacee Lerret, PhD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 25, 2018
• First Posted: May 22, 2018
• Study Start: October 1, 2018
• Primary Completion: April 1, 2020
• Study Completion: May 1, 2020
• Last Updated: July 9, 2020

Record last verified: 2020-07

Locations

US (1)