Malabsorption, Malnutrition, Short Bowel Syndrome
Conditions
Keywords
short bowel disorder, short bowel syndrome, home parenteral nutrition, HPN, total parenteral nutrition, TPN, telehealth, telemedicine
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.
Interventions
BEHAVIORALHPN Group Clinic Appointments using Mobile Devices (experimental)
Visual meetings with geographically distant professionals and peers using a mobile device (iPad mini).
BEHAVIORALMobile Device Access (placebo)
Use of iPad mini unrelated to the intervention until last contact with one connection to professionals for comparison.
Sponsors
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health Satisfaction SF-12 | 4 Months | Change from Baseline to 4 Months of the Health Survey SF-12v2 7-item Likert scale rating. |
| Quality of Life | 4 Months | Change from Baseline to 4 Months of the 3-item Likert scale rating using the Cantril Ladder. |
| Engagement in Healthy Living Activities | 4 Months | Change from Baseline to 4 Months of the logged frequency of healthy living activities with a 10-item Likert scale. |
| Access to Health Care | 4 Months | Change from Baseline to 4 Months of the 6-item Likert scale instrument rating. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Caregiving Burden | 4 Months | Change from Baseline to 4 Months of the rating from the Oberst Caregiving Burden Scale 15-item Likert scale. |
| Virtual Nurse Caring | 8 months | 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. |
| Preparedness to Manage Home-Care | 4 Months | Change from Baseline to 4 Months of the caregiver strain rating with and 8-item Likert scale. |
Countries
United States
Outcome results
None listed