Malabsorption, Malnutrition, Short Bowel Syndrome
Conditions
Keywords
Home Parenteral Nutrition, HPN, Total Parenteral Nutrition, TPN, mConnect, SBS, short bowel disorder, telehealth, telemedicine
Brief summary
12 month study testing mobile delivery of health information and connections to professionals and peers to improve health of teen/young adult HPN users.
Detailed description
This research study will test the effect of in-home/mobile HPN support delivered to teen and young adult home parenteral nutrition (HPN) patients and family members over handheld personal computers. Effects on health status, QoL, and fatigue will be assessed over time between groups of study subjects from the ages of 13 through 30 randomized to one of two groups. Group One (intervention group) will receive mConnect, integrated evidence-based interventions (skill-building games, restorative naps & peer support) via mobile iPad and Internet delivery plus two real-time audiovisual encrypted connections with multidisciplinary professionals and peers. Group Two (control group) will receive healthy activity information via mobile iPad and Internet delivery plus one real-time audiovisual encrypted connection with professionals and peers.
Interventions
BEHAVIORALmConnect plus mobile connections to multidisciplinary professionals & peers
mConnect is the integration of evidence-based HPN interventions delivered via professionally moderated iPad visual meetings with peers, and reinforced by HPN related skill-building games (apps) and iPad music guided short naps.
BEHAVIORALiPad use plus one mobile connections to multidisciplinary professionals & peers
iPad with a data plan and one professionally moderated iPad visual meeting with peers.
Sponsors
National Institute of Nursing Research (NINR)
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 30 Years
Healthy volunteers
No
Inclusion criteria
* Total parenteral nutrition (TPN) patients/users and family members/caregivers (defined as those individuals involved in daily home HPN care) age 13 and older * TPN users (also called HPN users) ages 13 through 30 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 |
|---|---|---|
| Beck Depression Inventory-II (BDI-II) | T0 (baseline data collection) | Assesses assess the intensity of depression into alignment with DSM-IV criteria. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. 21-Item |
| Use of Healthy Living Activities Prompts, health intentions that predict engagement in targeted activities. | T2 (month 1-2/mConnect intervention period) | Intention scale for healthy activities use (iPad discussion sessions, website use including games; mConnect use) 10-Item Likert |
| Health Survey SF-12v2 (predicts future health services use). | T0 (baseline data collection) | Physical and mental health status from each person's perspective. 7-Item Likert |
| Quality of Life (Cantril Ladder) | T0 (baseline data collection) | Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| COOPS Social Support Scale | T0 (baseline data collection) | Ratings on having others who help, listen & provide tangible assistance support. 13-Item Likert |
| Mobile Care Helpfulness & Willingness-to-Pay Fees for Distance Health. | T4 (8 months) | Rating of Helpfulness and willingness to pay for mobile care delivery. 10-Item Likert |
| Preparedness (measures skills needed for independent HPN home care). | T0 (baseline data collection) | Ability to manage home-care; low score = needs home care assistance. 8-Item Likert |
Countries
United States
Outcome results
None listed