Overview

This trial is active, not recruiting.

Conditions short bowel syndrome, malabsorption, malnutrition
Treatments hpn group clinic appointments using mobile devices (experimental), mobile device access (placebo)
Sponsor University of Kansas Medical Center
Collaborator National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Start date August 2012
End date December 2015
Trial size 90 participants
Trial identifier NCT01900288, 13337, R01EB015911

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(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.
hpn group clinic appointments using mobile devices (experimental) Healthy Living Connections
Visual meetings with geographically distant professionals and peers using a mobile device (iPad mini).
(Placebo Comparator)
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.
mobile device access (placebo) Placebo use of a mobile device
Use of iPad mini unrelated to the intervention until last contact with one connection to professionals for comparison.

Primary Outcomes

Measure
Engagement in Healthy Living Activities
time frame: 4 Months
Health Satisfaction SF-12
time frame: 4 Months
Quality of Life
time frame: 4 Months
Access to Health Care
time frame: 4 Months
Engagement in Healthy Living Activities
time frame: 8 Months
Health Satisfaction SF-12
time frame: 8 Months
Quality of Life
time frame: 8 Months
Access to Health Care
time frame: 8 months

Secondary Outcomes

Measure
Preparedness to Manage Home-Care
time frame: 4 Months
Caregiving Burden
time frame: 4 Months
Preparedness to Manage Home-Care
time frame: 8 Months
Caregiving Burden
time frame: 8 Months
Virtual Nurse Caring
time frame: 8 months

Eligibility Criteria

Male or female participants at least 13 years old.

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

Additional Information

Official title Mobile Technologies Assisting Patients & Family Caregivers in Healthy Living
Principal investigator Carol Smith, RN PhD FAAN
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by University of Kansas Medical Center.