NCT01565785

Brief Summary

The purpose of this study is to pilot test the 'Family Self- Management Discharge Preparation Intervention \[FSM-DPI\]' that focuses on content and delivery methods to support an effective family transition to home self-management after a child's hospitalization.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 29, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

November 17, 2015

Status Verified

November 1, 2015

Enrollment Period

1.5 years

First QC Date

March 26, 2012

Last Update Submit

November 16, 2015

Conditions

Keywords

Child parent home self-management

Outcome Measures

Primary Outcomes (1)

  • Post-Coping Difficulty

    The Post-Coping Difficulty Scale is a measure of parent perception of difficulty and ability to manage their child's care at home.

    3 weeks after discharge

Secondary Outcomes (1)

  • Pediatric Quality of Life (parent report)

    3 weeks after discharge

Study Arms (2)

Discharge Prepartion with The FSM-DPI

EXPERIMENTAL

25 families on each of 2 units will receive the will receive the Family Self-Management-Discharge Preparation Intervention (FSM-DPI). This scripted theory-based intervention is delivered by the study nurse using a e-mobile device. Eight elements of discharge preparation are addressed, the nurse assesses the family status and documents the additional care provided.

Behavioral: The FSM-DPI.

control group

NO INTERVENTION

25 parents on each unit receiving standard of care in discharge preparation.

Interventions

The FSM-DPI.BEHAVIORAL

Nurses will assess key elements of family self-management (home care, child's care, practice, medications, watching child, recovery, development, family adjustment and parental support) and address any deficits to facilitate effective discharge and family management of child at home after hospitalization.

Also known as: Tailored, behavioral
Discharge Prepartion with The FSM-DPI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parents must be at least 18 years of age, speak sufficient English to complete paper or online questionnaires, have a child who has been in the hospital for 2 days and is expected to go home on the data of data collection

You may not qualify if:

  • Parents will be excluded if their child is discharged home to hospice care, or if they were in the hospital less than 2 days, were admitted as a short stay, or remain in the hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53201, United States

Location

Study Officials

  • Kathleen J Sawin, PhD

    Children's Hospital and Health System Foundation, Wisconsin

    PRINCIPAL INVESTIGATOR
  • Marianne Weiss, DNSc, RN

    Marquette University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2012

First Posted

March 29, 2012

Study Start

February 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

November 17, 2015

Record last verified: 2015-11

Locations