Home Parenteral Nutrition (HPN) Families' Mobile Distance Connections to Care Research
Mobile Technologies Assisting Patients & Family Caregivers in Healthy Living
2 other identifiers
interventional
121
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 11, 2013
CompletedFirst Posted
Study publicly available on registry
July 16, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 23, 2016
CompletedJanuary 27, 2017
January 1, 2017
3.3 years
July 11, 2013
January 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
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
Health Satisfaction SF-12
Change from Baseline to 4 Months of the Health Survey SF-12v2 7-item Likert scale rating.
4 Months
Quality of Life
Change from Baseline to 4 Months of the 3-item Likert scale rating using the Cantril Ladder.
4 Months
Access to Health Care
Change from Baseline to 4 Months of the 6-item Likert scale instrument rating.
4 Months
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
Health Satisfaction SF-12
Change from Baseline to 8 Months of the Health Survey SF-12v2 7-item Likert scale rating.
8 Months
Quality of Life
Change from Baseline to 8 Months of the 3-item Likert scale rating using the Cantril Ladder.
8 Months
Access to Health Care
Change from Baseline to 8 Months Change of the 6-item Likert scale instrument rating.
8 months
Secondary Outcomes (5)
Preparedness to Manage Home-Care
4 Months
Caregiving Burden
4 Months
Preparedness to Manage Home-Care
8 Months
Caregiving Burden
8 Months
Virtual Nurse Caring
8 months
Study Arms (2)
HPN Group Clinic Appointments (Group 1)
EXPERIMENTALA 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.
Mobile Device Access (Group 2)
PLACEBO COMPARATORA 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.
Interventions
Visual meetings with geographically distant professionals and peers using a mobile device (iPad mini).
Use of iPad mini unrelated to the intervention until last contact with one connection to professionals for comparison.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- enteral nutrition dependency only
- less than 13 years of age
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carol Smith, RN PhD FAAN
University of Kansas
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2013
First Posted
July 16, 2013
Study Start
August 1, 2012
Primary Completion
December 1, 2015
Study Completion
December 23, 2016
Last Updated
January 27, 2017
Record last verified: 2017-01