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

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ClinicalTrials.gov Identifier: NCT00315094
Recruitment Status : Completed
First Posted : April 17, 2006
Last Update Posted : February 28, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Home Parenteral Nutrition Behavioral: Caregiving support interventions (FamTechCare)

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?

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Home Parenteral Nutrition (HPN) Infection, Depression and Improving Caregiving Problem Solving
Study Start Date : April 2006
Primary Completion Date : July 2010
Study Completion Date : November 2011
Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

Primary Outcome Measures :
  1. Catheter related infection, depression, problem-solving and quality of life scores. [ Time Frame: Experimental arm at T6, Control arm at T9. ]

Secondary Outcome Measures :
  1. Ratings of virtual nurse caring [ Time Frame: Experimental arm at T6, Control arm at T9. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Medical Center
More Information

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
First Posted: April 17, 2006    Key Record Dates
Last Update Posted: February 28, 2012
Last Verified: February 2012

Keywords provided by Carol Smith, RN, PhD, FAAN, University of Kansas:
home parenteral nutrition