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

February 27, 2012 updated by: Carol Smith, RN, PhD, FAAN, University of Kansas

Prevention of Home Parenteral Nutrition (HPN) Infection, Depression and Improving Caregiving Problem Solving

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

172

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Ratings of virtual nurse caring
Time Frame: Experimental arm at T6, Control arm at T9.
Experimental arm at T6, Control arm at T9.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Carol E Smith, PhD, RN, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

April 13, 2006

First Submitted That Met QC Criteria

April 13, 2006

First Posted (Estimate)

April 17, 2006

Study Record Updates

Last Update Posted (Estimate)

February 28, 2012

Last Update Submitted That Met QC Criteria

February 27, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 9655

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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