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

Malnutrition Clinical Trial

Official title:

Mobile Technologies Assisting Patients & Family Caregivers in Healthy Living

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01900288
• Other study ID #: 13337
• Secondary ID: R01EB015911
• Status: Completed
• Phase: N/A
• First received: July 11, 2013
• Last updated: January 26, 2017
• Start date: August 2012
• Est. completion date: December 23, 2016

Study information

• Verified date: January 2017
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: December 23, 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malabsorption
• Malabsorption Syndromes
• Malnutrition
• Short Bowel Syndrome

Intervention

Behavioral:
• HPN Group Clinic Appointments using Mobile Devices (experimental)
Visual meetings with geographically distant professionals and peers using a mobile device (iPad mini).
• Mobile Device Access (placebo)
Use of iPad mini unrelated to the intervention until last contact with one connection to professionals for comparison.

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 Institute for Biomedical Imaging and Bioengineering (NIBIB)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Engagement in Healthy Living Activities	Change from Baseline to 4 Months of the logged frequency of healthy living activities with a 10-item Likert scale.	4 Months
Primary	Health Satisfaction SF-12	Change from Baseline to 4 Months of the Health Survey SF-12v2 7-item Likert scale rating.	4 Months
Primary	Quality of Life	Change from Baseline to 4 Months of the 3-item Likert scale rating using the Cantril Ladder.	4 Months
Primary	Access to Health Care	Change from Baseline to 4 Months of the 6-item Likert scale instrument rating.	4 Months
Primary	Engagement in Healthy Living Activities	Change from Baseline to 8 Months of the logged frequency of healthy living activities with a 10-item Likert scale.	8 Months
Primary	Health Satisfaction SF-12	Change from Baseline to 8 Months of the Health Survey SF-12v2 7-item Likert scale rating.	8 Months
Primary	Quality of Life	Change from Baseline to 8 Months of the 3-item Likert scale rating using the Cantril Ladder.	8 Months
Primary	Access to Health Care	Change from Baseline to 8 Months Change of the 6-item Likert scale instrument rating.	8 months
Secondary	Preparedness to Manage Home-Care	Change from Baseline to 4 Months of the caregiver strain rating with and 8-item Likert scale.	4 Months
Secondary	Caregiving Burden	Change from Baseline to 4 Months of the rating from the Oberst Caregiving Burden Scale 15-item Likert scale.	4 Months
Secondary	Preparedness to Manage Home-Care	Change from Baseline to 8 Months Change from Baseline to 4 Months of the caregiver strain rating with and 8-item Likert scale.	8 Months
Secondary	Caregiving Burden	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.	8 Months
Secondary	Virtual Nurse Caring	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.	8 months