Clinical trial NCT02987569: Teen and Young Adult Connections for Support From Multidisciplinary Professionals & Peers
Official title: Teen Connections for Support From Multidisciplinary Professionals & Peers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Short Bowel Syndrome
Malabsorption
Malnutrition
Keywords: Home Parenteral Nutrition
HPN
Total Parenteral Nutrition
TPN
mConnect
SBS
short bowel disorder
telehealth
telemedicine
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2016-12-09
Enrollment: 83
Sex: ALL
Minimum age (years): 13
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Health Survey SF-12v2 (predicts future health services use).
timeFrame: T0 (baseline data collection)
measure: Quality of Life (Cantril Ladder)
timeFrame: T0 (baseline data collection)
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: T0 (baseline data collection)
measure: Use of Healthy Living Activities Prompts, health intentions that predict engagement in targeted activities.
timeFrame: T2 (month 1-2/mConnect intervention period)
measure: Use of Healthy Living Activities Prompts, health intentions that predict engagement in targeted activities.
timeFrame: T3 (month 3-4/mConnect intervention period)
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: T3 (4 months: change from T0/baseline)
measure: Health Survey SF-12v2 (predicts future health services use).
timeFrame: T3 (4 months: change from T0/baseline)
measure: Quality of Life (Cantril Ladder)
timeFrame: T3 (4 months: change from T0/baseline)
measure: Health Survey SF-12v2 (predicts future health services use).
timeFrame: T4 (8 months: change from T3/4 months)
measure: Quality of Life (Cantril Ladder)
timeFrame: T4 (8 months: change from T3/4 months)
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: T4 (8 months: change from T3/4 months)
measure: Health Survey SF-12v2 (predicts future health services use).
timeFrame: T5 (12 months: change from T4/8 months)
measure: Quality of Life (Cantril Ladder)
timeFrame: T5 (12 months: change from T4/8 months)
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: T5 (12 months: change from T4/8 months)
Secondary outcomes:
measure: Preparedness (measures skills needed for independent HPN home care).
timeFrame: T0 (baseline data collection)
measure: COOPS Social Support Scale
timeFrame: T0 (baseline data collection)
measure: Preparedness (measures skills needed for independent HPN home care).
timeFrame: T3 (4 months: change from T0/baseline)
measure: COOPS Social Support Scale
timeFrame: T3 (4 months: change from T0/baseline)
measure: Mobile Care Helpfulness & Willingness-to-Pay Fees for Distance Health.
timeFrame: T4 (8 months)
measure: Preparedness (measures skills needed for independent HPN home care).
timeFrame: T4 (8 months: change from T3/4 months)
measure: COOPS Social Support Scale
timeFrame: T4 (8 months: change from T3/4 months)
measure: Preparedness (measures skills needed for independent HPN home care).
timeFrame: T5 (12 months: change from T4/8 months)
measure: COOPS Social Support Scale
timeFrame: T5 (12 months: change from T4/8 months)
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Carol E Smith, RN, PhD, FAAN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nelson EL, Yadrich DM, Thompson N, Wright S, Stone K, Adams N, Werkowitch M, Smith CE. Telemedicine Support Groups for Home Parenteral Nutrition Users. Nutr Clin Pract. 2017 Dec;32(6):789-798. doi: 10.1177/0884533617735527. Epub 2017 Oct 10.