Technological Home Care: Improving HPN Care With Videophone And Internet Education - Full Text View

Sponsors and Collaborators:	University of Kansas National Institutes of Health (NIH)
Information provided by:	University of Kansas
ClinicalTrials.gov Identifier:	NCT00315094

Purpose

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.

Condition	Intervention
Home Parenteral Nutrition	Behavioral: Caregiving support interventions (FamTechCare)

MedlinePlus related topics: Depression

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Placebo Control, Crossover Assignment
Official Title:	Prevention of Home Parenteral Nutrition (HPN) Infection, Depression and Improving Caregiving Problem Solving

Further study details as provided by University of Kansas:

Primary Outcome Measures:

Catheter related infection, depression, problem-solving and quality of life scores. [ Time Frame: Experimental arm at T6, Control arm at T9. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Ratings of virtual nurse caring [ Time Frame: Experimental arm at T6, Control arm at T9. ] [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	April 2006
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Behavioral: Caregiving support interventions (FamTechCare) 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.
2: No Intervention After a control period, this group crosses over to experimental interventions (Arm 1)

Arms

Assigned Interventions

1: Experimental

Behavioral: Caregiving support interventions (FamTechCare)

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.

2: No Intervention

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

Detailed Description:

Aim #1 Hypothesis

Dyad (patient-caregiver) participation in health care management and problem-solving method use with professionals will be greater in the experimental group than the control group
Dyad reactive depression will be lower in the experimental group than the control group
Dyad quality of life will be higher in the experimental group than the control group
Dyad health status scores will be higher and the dyad sleepiness scale will be lower in experimental group than the control group
Dyad Health Services Use will be lower in the experimental group than the control group
Catheter-related infections will be lower in the experimental than control patients

Aim #2 Hypotheses:

What is the cost of using the FamTechCare system compared to traditional care?
Is there a difference between efficiency scores of the experimental and control groups intervention, boosters and relative to dyads long-term health services use at 24 months?
What are the relationships among patient outcome variables and caregivers' rating of virtual nurse caring and caregiver adaption?
What are the relationships among use of FamTechCare, dyad participation in health care management scale score and dyad access to the Internet Weighted Score?

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315094

Locations

United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160

Sponsors and Collaborators

University of Kansas

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Carol E Smith, PhD, RN

University of Kansas

More Information

No publications provided

Responsible Party:	University of Kansas Medical Center ( Carol E Smith, PhD, RN )
Study ID Numbers:	9655
Study First Received:	April 13, 2006
Last Updated:	September 4, 2008
ClinicalTrials.gov Identifier:	NCT00315094 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Kansas:

home parenteral nutrition

Study placed in the following topic categories:

Depression
Depressive Disorder

ClinicalTrials.gov processed this record on May 07, 2009