Technological Home Care: Improving HPN Care With Videopho... | NCT00315094

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

NCT00315094

Sponsor

University of Kansas

Status

Completed

Last Update Posted

Feb 28, 2012Estimated

Enrollment

172Actual

Phase

Not Applicable

Conditions

Home Parenteral Nutrition

Interventions

Caregiving support interventions (FamTechCare)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

Jul 2010Actual

Completion Date

Nov 2011Actual

First Submitted Date

Apr 13, 2006

First Submission Date that Met QC Criteria

Apr 13, 2006

First Posted Date

Apr 17, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2012

Last Update Posted Date

Feb 28, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Carol Smith, RN, PhD, FAAN, Professor, School of Nursing, University of KansasPrincipal Investigator

Lead Sponsor

University of KansasOTHER

Collaborators

Name	Class
National Institutes of Health (NIH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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

Aim #2 Hypotheses:

What is the cost of using the FamTechCare system compared to traditional care?
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?
What are the relationships among patient outcome variables and caregivers' rating of virtual nurse caring and caregiver adaption?
What are the relationships among use of FamTechCare, dyad participation in health care management scale score and dyad access to the Internet Weighted Score?

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

172Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Behavioral: Caregiving support interventions (FamTechCare)
2	No Intervention	After a control period, this group crosses over to experimental interventions (Arm 1)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Caregiving support interventions (FamTechCare)	Behavioral	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carol E Smith, PhD, RN	University of Kansas Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Kansas Medical Center		Kansas City	Kansas	66160	United States