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

NCT ID: NCT01900288

Last Updated: 2017-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2016-12-23

Brief Summary

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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

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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.

Conditions

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Short Bowel Syndrome Malabsorption Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

HPN Group Clinic Appointments using Mobile Devices (experimental)

Intervention Type BEHAVIORAL

Visual meetings with geographically distant professionals and peers using a mobile device (iPad mini).

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.

Group Type PLACEBO_COMPARATOR

Mobile Device Access (placebo)

Intervention Type BEHAVIORAL

Use of iPad mini unrelated to the intervention until last contact with one connection to professionals for comparison.

Interventions

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HPN Group Clinic Appointments using Mobile Devices (experimental)

Visual meetings with geographically distant professionals and peers using a mobile device (iPad mini).

Intervention Type BEHAVIORAL

Mobile Device Access (placebo)

Use of iPad mini unrelated to the intervention until last contact with one connection to professionals for comparison.

Intervention Type BEHAVIORAL

Other Intervention Names

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Healthy Living Connections Placebo use of a mobile device

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute for Biomedical Imaging and Bioengineering (NIBIB)

NIH

Sponsor Role collaborator

University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carol Smith, RN PhD FAAN

Role: PRINCIPAL_INVESTIGATOR

University of Kansas

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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R01EB015911

Identifier Type: NIH

Identifier Source: secondary_id

View Link

13337

Identifier Type: -

Identifier Source: org_study_id

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