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

Mobile Technologies Assisting Patients & Family Caregivers in Healthy Living

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.

Study Overview

• Status: Completed
• Conditions: Malnutrition; Malabsorption; Short Bowel Syndrome
• Intervention / Treatment: Behavioral: HPN Group Clinic Appointments using Mobile Devices (experimental); Behavioral: Mobile Device Access (placebo)

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 Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: HPN Group Clinic Appointments (Group 1); 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.	Behavioral: HPN Group Clinic Appointments using Mobile Devices (experimental); Visual meetings with geographically distant professionals and peers using a mobile device (iPad mini).; Other Names: Healthy Living Connections
PLACEBO_COMPARATOR: Mobile Device Access (Group 2); 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.	Behavioral: Mobile Device Access (placebo); Use of iPad mini unrelated to the intervention until last contact with one connection to professionals for comparison.; Other Names: Placebo use of a mobile device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Health Satisfaction SF-12	Change from Baseline to 4 Months of the Health Survey SF-12v2 7-item Likert scale rating.	4 Months
Quality of Life	Change from Baseline to 4 Months of the 3-item Likert scale rating using the Cantril Ladder.	4 Months
Access to Health Care	Change from Baseline to 4 Months of the 6-item Likert scale instrument rating.	4 Months
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
Health Satisfaction SF-12	Change from Baseline to 8 Months of the Health Survey SF-12v2 7-item Likert scale rating.	8 Months
Quality of Life	Change from Baseline to 8 Months of the 3-item Likert scale rating using the Cantril Ladder.	8 Months
Access to Health Care	Change from Baseline to 8 Months Change of the 6-item Likert scale instrument rating.	8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preparedness to Manage Home-Care	Change from Baseline to 4 Months of the caregiver strain rating with and 8-item Likert scale.	4 Months
Caregiving Burden	Change from Baseline to 4 Months of the rating from the Oberst Caregiving Burden Scale 15-item Likert scale.	4 Months
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
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
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

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
• Investigators: Principal Investigator: Carol Smith, RN PhD FAAN, University of Kansas

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): December 23, 2016

Study Registration Dates

• First Submitted: July 11, 2013
• First Submitted That Met QC Criteria: July 11, 2013
• First Posted (ESTIMATE): July 16, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): January 27, 2017
• Last Update Submitted That Met QC Criteria: January 26, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: telemedicine; short bowel syndrome; telehealth; home parenteral nutrition; total parenteral nutrition; TPN; HPN; short bowel disorder
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Metabolic Diseases; Postoperative Complications; Gastrointestinal Diseases; Nutrition Disorders; Intestinal Diseases; Malnutrition; Malabsorption Syndromes; Short Bowel Syndrome
• Other Study ID Numbers: 13337; R01EB015911 (NIH)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No