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

University of Kansas

Status: Completed

Conditions: Short Bowel Syndrome; Malnutrition; Malabsorption

Treatments: Behavioral: Mobile Device Access (placebo); Behavioral: HPN Group Clinic Appointments using Mobile Devices (experimental)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01900288

13337

R01EB015911 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 121 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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121 participants in 2 patient groups, including a placebo group

HPN Group Clinic Appointments (Group 1)

Experimental group

Description:

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.

Treatment:

Behavioral: HPN Group Clinic Appointments using Mobile Devices (experimental)

Mobile Device Access (Group 2)

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Mobile Device Access (placebo)