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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02165423
Other study ID # CHW 14/66
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2014
Est. completion date October 2018

Study information

Verified date March 2019
Source Medical College of Wisconsin
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date October 2018
Est. primary completion date October 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
myFAMI iPad application


Locations

Country Name City State
United States Children's Hospital of Wisconsin Milwaukee Wisconsin

Sponsors (2)

Lead Sponsor Collaborator
Medical College of Wisconsin Children's Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Examine the acceptability of myFAMI: 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
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