Back to resultsHome Parenteral Nutrition (HPN) Families' Mobile Distance Connections to Care Research
Primary Purpose
Short Bowel Syndrome, Malabsorption, Malnutrition
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HPN Group Clinic Appointments using Mobile Devices (experimental)
Mobile Device Access (placebo)
Sponsored by
About this trial
This is an interventional health services research trial for Short Bowel Syndrome focused on measuring short bowel disorder, short bowel syndrome, home parenteral nutrition, HPN, total parenteral nutrition, TPN, telehealth, telemedicine
Eligibility 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
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
HPN Group Clinic Appointments (Group 1)
Mobile Device Access (Group 2)
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Health Satisfaction SF-12
Change from Baseline to 4 Months of the Health Survey SF-12v2 7-item Likert scale rating.
Quality of Life
Change from Baseline to 4 Months of the 3-item Likert scale rating using the Cantril Ladder.
Access to Health Care
Change from Baseline to 4 Months of the 6-item Likert scale instrument rating.
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.
Health Satisfaction SF-12
Change from Baseline to 8 Months of the Health Survey SF-12v2 7-item Likert scale rating.
Quality of Life
Change from Baseline to 8 Months of the 3-item Likert scale rating using the Cantril Ladder.
Access to Health Care
Change from Baseline to 8 Months Change of the 6-item Likert scale instrument rating.
Secondary Outcome Measures
Preparedness to Manage Home-Care
Change from Baseline to 4 Months of the caregiver strain rating with and 8-item Likert scale.
Caregiving Burden
Change from Baseline to 4 Months of the rating from the Oberst Caregiving Burden Scale 15-item Likert scale.
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.
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.
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.
Full Information
NCT ID
NCT01900288
First Posted
July 11, 2013
Last Updated
January 26, 2017
Sponsor
University of Kansas Medical Center
Collaborators
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
1. Study Identification
Unique Protocol Identification Number
NCT01900288
Brief Title
Home Parenteral Nutrition (HPN) Families' Mobile Distance Connections to Care Research
Official Title
Mobile Technologies Assisting Patients & Family Caregivers in Healthy Living
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 23, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
Collaborators
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Short Bowel Syndrome, Malabsorption, Malnutrition
Keywords
short bowel disorder, short bowel syndrome, home parenteral nutrition, HPN, total parenteral nutrition, TPN, telehealth, telemedicine
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HPN Group Clinic Appointments (Group 1)
Arm Type
Experimental
Arm 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.
Arm Title
Mobile Device Access (Group 2)
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
HPN Group Clinic Appointments using Mobile Devices (experimental)
Other Intervention Name(s)
Healthy Living Connections
Intervention Description
Visual meetings with geographically distant professionals and peers using a mobile device (iPad mini).
Intervention Type
Behavioral
Intervention Name(s)
Mobile Device Access (placebo)
Other Intervention Name(s)
Placebo use of a mobile device
Intervention Description
Use of iPad mini unrelated to the intervention until last contact with one connection to professionals for comparison.
Primary Outcome Measure Information:
Title
Engagement in Healthy Living Activities
Description
Change from Baseline to 4 Months of the logged frequency of healthy living activities with a 10-item Likert scale.
Time Frame
4 Months
Title
Health Satisfaction SF-12
Description
Change from Baseline to 4 Months of the Health Survey SF-12v2 7-item Likert scale rating.
Time Frame
4 Months
Title
Quality of Life
Description
Change from Baseline to 4 Months of the 3-item Likert scale rating using the Cantril Ladder.
Time Frame
4 Months
Title
Access to Health Care
Description
Change from Baseline to 4 Months of the 6-item Likert scale instrument rating.
Time Frame
4 Months
Title
Engagement in Healthy Living Activities
Description
Change from Baseline to 8 Months of the logged frequency of healthy living activities with a 10-item Likert scale.
Time Frame
8 Months
Title
Health Satisfaction SF-12
Description
Change from Baseline to 8 Months of the Health Survey SF-12v2 7-item Likert scale rating.
Time Frame
8 Months
Title
Quality of Life
Description
Change from Baseline to 8 Months of the 3-item Likert scale rating using the Cantril Ladder.
Time Frame
8 Months
Title
Access to Health Care
Description
Change from Baseline to 8 Months Change of the 6-item Likert scale instrument rating.
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Preparedness to Manage Home-Care
Description
Change from Baseline to 4 Months of the caregiver strain rating with and 8-item Likert scale.
Time Frame
4 Months
Title
Caregiving Burden
Description
Change from Baseline to 4 Months of the rating from the Oberst Caregiving Burden Scale 15-item Likert scale.
Time Frame
4 Months
Title
Preparedness to Manage Home-Care
Description
Change from Baseline to 8 Months Change from Baseline to 4 Months of the caregiver strain rating with and 8-item Likert scale.
Time Frame
8 Months
Title
Caregiving Burden
Description
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.
Time Frame
8 Months
Title
Virtual Nurse Caring
Description
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.
Time Frame
8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol Smith, RN PhD FAAN
Organizational Affiliation
University of Kansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Home Parenteral Nutrition (HPN) Families' Mobile Distance Connections to Care Research
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