Discharge to Home and Chronic Illness Care Pilot

March 6, 2019 updated by: Stacee Lerret, Medical College of Wisconsin
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Children's Hospital of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control
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
Experimental: Intervention
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the effectiveness of myFAMI on 30-day post-discharge outcomes.
Time Frame: 30 days following enrollment

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Examine the acceptability of myFAMI:
Time Frame: Enrollment plus 30 days
2. Examine the acceptability of myFAMI: The content of the interview will focus on strengths and weaknesses of iPad® technology in preparing parents for hospital discharge utilizing both survey and qualitative questions
Enrollment plus 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Collaborators

Children's National Research Institute

Investigators

  • Principal Investigator: Stacee Lerret, PhD, Medical College of Wisconsin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

June 12, 2014

First Submitted That Met QC Criteria

June 16, 2014

First Posted (Estimate)

June 17, 2014

Study Record Updates

Last Update Posted (Actual)

March 7, 2019

Last Update Submitted That Met QC Criteria

March 6, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHW 14/66

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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