NCT00315094

Brief Summary

The purpose of this study is to help people with home parenteral nutrition (HPN) to avoid infections and feelings of depression or fatigue and to test how their health and quality of life change over time. Another purpose is to test the nurse teaching sessions and the method of obtaining support from the peer partner through videophone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
172

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2006

Longer than P75 for not_applicable

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

April 1, 2006

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 17, 2006

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

February 28, 2012

Status Verified

February 1, 2012

Enrollment Period

4.3 years

First QC Date

April 13, 2006

Last Update Submit

February 27, 2012

Conditions

Home Parenteral Nutrition

Keywords

home parenteral nutrition

Outcome Measures

Primary Outcomes (1)

  • Catheter related infection, depression, problem-solving and quality of life scores.

    Experimental arm at T6, Control arm at T9.

Secondary Outcomes (1)

  • Ratings of virtual nurse caring

    Experimental arm at T6, Control arm at T9.

Study Arms (2)

1

EXPERIMENTAL
Behavioral: Caregiving support interventions (FamTechCare)

2

NO INTERVENTION

After a control period, this group crosses over to experimental interventions (Arm 1)

Interventions

Caregiving support interventions (FamTechCare)BEHAVIORAL

One set of combined interventions to be tested in this study are nursing interventions for the prevention of catheter-related infection, reactive depression, and HPN home care problem-solving. The other set of combined interventions are for increasing social support and use of a short nap to reduce daily fatigue. Information about all the interventions were incorporated into Internet formats as a booster for reinforcement.

1

Eligibility Criteria

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

You may qualify if:

  • years or older
  • Caregivers of HPN patients short- or long-term HPN
  • able to participate in writing and other intervention activities
  • able to speak/read/write English or Spanish

You may not qualify if:

  • Patients with psychiatric disorders (e.g., schizophrenia, hallucinations) and physical disabilities that prevent use of intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Study Officials

  • Carol E Smith, PhD, RN

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, School of Nursing

Study Record Dates

First Submitted

April 13, 2006

First Posted

April 17, 2006

Study Start

April 1, 2006

Primary Completion

July 1, 2010

Study Completion

November 1, 2011

Last Updated

February 28, 2012

Record last verified: 2012-02

Locations

US(1)