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

Not Applicable

Completed

• Conditions: Malabsorption; Malnutrition; Short Bowel Syndrome
• Interventions: Behavioral: HPN Group Clinic Appointments using Mobile Devices (experimental); Behavioral: Mobile Device Access (placebo)

• 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

Arm && Interventions

Group	Intervention	Description
HPN Group Clinic Appointments (Group 1)	HPN Group Clinic Appointments using Mobile Devices (experimental)	A mobile device (iPad mini) is loaned to Group 1 subjects providing a connection to HPN Internet information for the 6 to 12 months of the study. Two scheduled times during the study period, visual connections to geographically distant professionals and peers over the iPad mini (HPN Group Clinic Appointment) will be held for approximately 1 ½ to 2 hours each time (called Healthy Living Connections). On the iPad mini screen during the HPN Group Clinic Appointments, subjects will be able to see professionals and peers all at the same time and they will be able to see them in their home. This group will also receive electronic prompts about healthy activities.
Mobile Device Access (Group 2)	Mobile Device Access (placebo)	A mobile device (iPad mini) is loaned to Group 2 subjects providing a connection to Internet information for the 6 to12 months of the study. At the end of the study period, Group 2 subjects will have 1 scheduled time during the study to connect to professionals and peers over the iPad mini for approximately 1 ½ to 2 hours (called Healthy Living Connections) before the study concludes. On the iPad mini screen during the placebo control group clinics, subjects will be able to see professionals and peers all at the same time and they will be able to see them in their home. This group will also receive one electronic prompt about healthy activities as a comparison control to the intervention group.

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