Clinical trial NCT00315094: Technological Home Care: Improving HPN Care With Videophone And Internet Education
Official title: Prevention of Home Parenteral Nutrition (HPN) Infection, Depression and Improving Caregiving Problem Solving
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Home Parenteral Nutrition
Keywords: home parenteral nutrition
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2006-04-17
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: Catheter related infection, depression, problem-solving and quality of life scores.
timeFrame: Experimental arm at T6, Control arm at T9.
Secondary outcomes:
measure: Ratings of virtual nurse caring
timeFrame: Experimental arm at T6, Control arm at T9.
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Carol E Smith, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: