Home Parenteral Nutrition (HPN) Families' Mobile Distance Connections to Care Research

Not Applicable

Completed

• Conditions: Malabsorption; Malnutrition; Short Bowel Syndrome

• Registration Number: NCT01900288
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

The purpose of this study is to test Mobile Technologies in Assisting Patients \& Family Caregivers in Healthy Living and complex home care by connecting to information and professionals from a distance.

Detailed Description

HPN (Home Parenteral Nutrition) families with TPN (Total Parenteral Nutrition) users are typically geographically distant from one another (peers) as well as professional providers. Real-time mobile access to health related information, peer and professional support will be tested in this study.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2013-07-11
• Study First Submitted QC: 2013-07-11
• Study First Posted: 2013-07-16
• Primary Completion: 2015-12
• Study Completion: 2016-12-23
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-26
• Last Update Posted: 2017-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

• 13 years or older total parenteral nutrition (TPN) patients/users and family members/caregivers (defined as those individuals involved in daily home HPN care)
• TPN users (also called HPN users) must be receiving intravenous nutrition for a non-malignant short bowel disorder
• Read, write, speak English and provide informed consent
• Be able to participate in group clinic visits

Exclusion Criteria

• enteral nutrition dependency only
• less than 13 years of age
• 13 through 17 years of age without parental consent
• currently enrolled in an intervention study or HPN management program
• severe cognitive impairment
• disability disorders (e.g. blindness which cannot be accommodated for active participation in the group clinics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Engagement in Healthy Living Activities	8 Months	Change from Baseline to 8 Months of the logged frequency of healthy living activities with a 10-item Likert scale.
Quality of Life	8 Months	Change from Baseline to 8 Months of the 3-item Likert scale rating using the Cantril Ladder.
Access to Health Care	8 months	Change from Baseline to 8 Months Change of the 6-item Likert scale instrument rating.
Health Satisfaction SF-12	8 Months	Change from Baseline to 8 Months of the Health Survey SF-12v2 7-item Likert scale rating.

Secondary Outcome Measures

Name	Time	Method
Virtual Nurse Caring	8 months	At 8 months, using the Virtual Nurse Caring 20-item Likert scale instrument, caregiver's rating of perception of nurse care and needs met via mobile device is assessed.
Caregiving Burden	8 Months	Change from Baseline to 8 Months Change from Baseline to 4 Months of the rating from the Oberst Caregiving Burden Scale 15-item Likert scale.
Preparedness to Manage Home-Care	8 Months	Change from Baseline to 8 Months Change from Baseline to 4 Months of the caregiver strain rating with and 8-item Likert scale.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States