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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Kansas
Sponsor:
Collaborator:
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Information provided by (Responsible Party):
Carol Smith, RN, PhD, FAAN, University of Kansas
ClinicalTrials.gov Identifier:
NCT01900288
First received: July 11, 2013
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Short Bowel Syndrome
Malabsorption
Malnutrition
Behavioral: HPN Group Clinic Appointments using Mobile Devices (experimental)
Behavioral: Mobile Device Access (placebo)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Mobile Technologies Assisting Patients & Family Caregivers in Healthy Living

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Engagement in Healthy Living Activities [ Time Frame: 4 Months ] [ Designated as safety issue: No ]
    Change from Baseline to 4 Months of the logged frequency of healthy living activities with a 10-item Likert scale.

  • Health Satisfaction SF-12 [ Time Frame: 4 Months ] [ Designated as safety issue: No ]
    Change from Baseline to 4 Months of the Health Survey SF-12v2 7-item Likert scale rating.

  • Quality of Life [ Time Frame: 4 Months ] [ Designated as safety issue: No ]
    Change from Baseline to 4 Months of the 3-item Likert scale rating using the Cantril Ladder.

  • Access to Health Care [ Time Frame: 4 Months ] [ Designated as safety issue: No ]
    Change from Baseline to 4 Months of the 6-item Likert scale instrument rating.

  • Engagement in Healthy Living Activities [ Time Frame: 8 Months ] [ Designated as safety issue: No ]
    Change from Baseline to 8 Months of the logged frequency of healthy living activities with a 10-item Likert scale.

  • Health Satisfaction SF-12 [ Time Frame: 8 Months ] [ Designated as safety issue: No ]
    Change from Baseline to 8 Months of the Health Survey SF-12v2 7-item Likert scale rating.

  • Quality of Life [ Time Frame: 8 Months ] [ Designated as safety issue: No ]
    Change from Baseline to 8 Months of the 3-item Likert scale rating using the Cantril Ladder.

  • Access to Health Care [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Change from Baseline to 8 Months Change of the 6-item Likert scale instrument rating.


Secondary Outcome Measures:
  • Preparedness to Manage Home-Care [ Time Frame: 4 Months ] [ Designated as safety issue: No ]
    Change from Baseline to 4 Months of the caregiver strain rating with and 8-item Likert scale.

  • Caregiving Burden [ Time Frame: 4 Months ] [ Designated as safety issue: No ]
    Change from Baseline to 4 Months of the rating from the Oberst Caregiving Burden Scale 15-item Likert scale.

  • Preparedness to Manage Home-Care [ Time Frame: 8 Months ] [ Designated as safety issue: No ]
    Change from Baseline to 8 Months Change from Baseline to 4 Months of the caregiver strain rating with and 8-item Likert scale.

  • Caregiving Burden [ Time Frame: 8 Months ] [ Designated as safety issue: No ]
    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.

  • Virtual Nurse Caring [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 90
Study Start Date: August 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Placebo use of a mobile device

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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01900288

Locations
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Donna M Yadrich, MPA, CCRP       dyadrich@kumc.edu   
Contact: Ubolrat Piamjariyakul, PhD, RN    913-588-1544    upiamjariyakul@kumc.edu   
Principal Investigator: Carol Smith, RN, PhD, FAAN         
Sub-Investigator: Ryan Spaulding, PhD         
Sub-Investigator: Jo Wick, PhD         
Sponsors and Collaborators
University of Kansas
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Investigators
Principal Investigator: Carol Smith, RN PhD FAAN University of Kansas
  More Information

No publications provided

Responsible Party: Carol Smith, RN, PhD, FAAN, Professor, School of Nursing, University of Kansas
ClinicalTrials.gov Identifier: NCT01900288     History of Changes
Other Study ID Numbers: 13337, R01EB015911
Study First Received: July 11, 2013
Last Updated: April 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
short bowel disorder
short bowel syndrome
home parenteral nutrition
HPN
total parenteral nutrition
TPN
telehealth
telemedicine

Additional relevant MeSH terms:
Malabsorption Syndromes
Syndrome
Malnutrition
Nutrition Disorders
Short Bowel Syndrome
Disease
Pathologic Processes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014