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

Home Parenteral Nutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00315094
• Other study ID #: 9655
• Status: Completed
• Phase: N/A
• First received: April 13, 2006
• Last updated: February 27, 2012
• Start date: April 2006
• Est. completion date: November 2011

Study information

• Verified date: February 2012
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: November 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Home Parenteral Nutrition

Intervention

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.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Catheter related infection, depression, problem-solving and quality of life scores.		Experimental arm at T6, Control arm at T9.	No
Secondary	Ratings of virtual nurse caring		Experimental arm at T6, Control arm at T9.	No