Teen and Young Adult Connections for Support From Multidisciplinary Professionals & Peers

Not Applicable

Completed

• Conditions: Malnutrition; Short Bowel Syndrome; Malabsorption
• Interventions: Behavioral: mConnect plus mobile connections to multidisciplinary professionals & peers; Behavioral: iPad use plus one mobile connections to multidisciplinary professionals & peers

• Registration Number: NCT02987569
• Lead Sponsor: University of Kansas Medical Center

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.

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-12-06
• Study First Submitted QC: 2016-12-08
• Study First Posted: 2016-12-09
• Primary Completion: 2019-12
• Study Completion: 2020-06
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-30
• Last Update Posted: 2020-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group One	mConnect plus mobile connections to multidisciplinary professionals & peers	Intervention
Group Two	iPad use plus one mobile connections to multidisciplinary professionals & peers	Control

Primary Outcome Measures

Name	Time	Method
Health Survey SF-12v2 (predicts future health services use).	T5 (12 months: change from T4/8 months)	Physical and mental health status from each person's perspective. 7-Item Likert
Quality of Life (Cantril Ladder)	T5 (12 months: change from T4/8 months)	Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert
Use of Healthy Living Activities Prompts, health intentions that predict engagement in targeted activities.	T3 (month 3-4/mConnect intervention period)	Intention scale for healthy activities use (iPad discussion sessions, website use including games; mConnect use) 10-Item Likert
Beck Depression Inventory-II (BDI-II)	T5 (12 months: change from T4/8 months)	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

Secondary Outcome Measures

Name	Time	Method
Preparedness (measures skills needed for independent HPN home care).	T5 (12 months: change from T4/8 months)	Ability to manage home-care; low score = needs home care assistance. 8-Item Likert
COOPS Social Support Scale	T5 (12 months: change from T4/8 months)	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

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States