Discharge to Home and Chronic Illness Care Pilot

NCT02165423 | Completed

• 1 other identifier: CHW 14/66
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to address a gap in knowledge needed for care of children with solid organ transplantation (SOT) and their parents by combining mHealth technology with an individualized family centered self-management intervention (referred to as myFAMI). This study is critical to the increased understanding of hospital to home transition and family management at home with the potential to transform the way clinicians approach the care of complex chronic illness children and families.

Conditions

Solid Organ Transplant

Keywords

pediatric; solid organ transplant; parents; heart; kidney; liver

Outcome Measures

Primary Outcomes (1)

• Evaluate the effectiveness of myFAMI on 30-day post-discharge outcomes.

  Hypothesis: Compared to parents who received standard discharge preparation (usual care), parents receiving myFAMI will report: i) Better care coordination, ii) Higher quality of discharge teaching, iii) Greater readiness for hospital discharge, iv) Improved post-discharge coping, v) Improved family functioning, vi) Better self-management of medication and treatment regimens vii) Fewer emergency department visits and hospital readmissions

  30 days following enrollment

Secondary Outcomes (1)

• Examine the acceptability of myFAMI:

  Enrollment plus 30 days

Study Arms (2)

Control

EXPERIMENTAL

Ten parents will be randomized to the control group defined as 'usual care' and ten to the intervention group, stratified by type of transplant.

Behavioral: myFAMI iPad application

Intervention

EXPERIMENTAL

Ten parents will be randomized to the control group defined as 'usual care' and ten to the intervention group, stratified by type of transplant.

Behavioral: myFAMI iPad application

Interventions

myFAMI iPad application BEHAVIORAL

Control; Intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• parent's child has undergone a heart, kidney, or liver transplant and is being discharged home from the hospital
• the parent is English speaking (to date the tools being used have been validated for English participants only)
• parent is 18 years of age or older
• patient is 17 years of age and younger.

You may not qualify if:

• presence of significant communication or cognitive impairment on the part of the parent that would preclude completion of questionnaires based on self-report
• parent and child has experienced the discharge to home transition from a previous transplant.

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Children's National Research Institute: collaborator

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

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: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 12, 2014
• First Posted: June 17, 2014
• Study Start: June 1, 2014
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: March 7, 2019

Record last verified: 2019-03

Locations

US (1)