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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
Health authority
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

Study Design


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
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