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Technological Home Care: Improving HPN Care With Videophone And Internet Education

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Carol Smith, RN, PhD, FAAN, University of Kansas
ClinicalTrials.gov Identifier:
NCT00315094
First received: April 13, 2006
Last updated: February 27, 2012
Last verified: February 2012
History of Changes
  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)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Home Parenteral Nutrition (HPN) Infection, Depression and Improving Caregiving Problem Solving

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

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 ]

Enrollment: 172
Study Start Date: April 2006
Study Completion Date: November 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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.
No Intervention: 2
After a control period, this group crosses over to experimental interventions (Arm 1)

Detailed Description:

Aim #1 Hypothesis

  1. 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
  2. Dyad reactive depression will be lower in the experimental group than the control group
  3. Dyad quality of life will be higher in the experimental group than the control group
  4. Dyad health status scores will be higher and the dyad sleepiness scale will be lower in experimental group than the control group
  5. Dyad Health Services Use will be lower in the experimental group than the control group
  6. Catheter-related infections will be lower in the experimental than control patients

Aim #2 Hypotheses:

  1. What is the cost of using the FamTechCare system compared to traditional care?
  2. 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?
  3. What are the relationships among patient outcome variables and caregivers' rating of virtual nurse caring and caregiver adaption?
  4. 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: Carol Smith, RN, PhD, FAAN, Professor, School of Nursing, University of Kansas
ClinicalTrials.gov Identifier: NCT00315094     History of Changes
Other Study ID Numbers: 9655
Study First Received: April 13, 2006
Last Updated: February 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
home parenteral nutrition

ClinicalTrials.gov processed this record on May 23, 2013