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

Teen Connections for Support From Multidisciplinary Professionals & Peers

12 month study testing mobile delivery of health information and connections to professionals and peers to improve health of teen/young adult HPN users.

Study Overview

• Status: Completed
• Conditions: Malnutrition; Malabsorption; Short Bowel Syndrome
• Intervention / Treatment: Behavioral: mConnect plus mobile connections to multidisciplinary professionals & peers; Behavioral: iPad use plus one mobile connections to multidisciplinary professionals & peers

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 Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University Of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group One; Intervention	Behavioral: mConnect 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.
Active Comparator: Group Two; Control	Behavioral: iPad use plus one mobile connections to multidisciplinary professionals & peers; iPad with a data plan and one professionally moderated iPad visual meeting with peers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Survey SF-12v2 (predicts future health services use).	Physical and mental health status from each person's perspective. 7-Item Likert	T0 (baseline data collection)
Quality of Life (Cantril Ladder)	Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert	T0 (baseline data collection)
Beck Depression Inventory-II (BDI-II)	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	T0 (baseline data collection)
Use of Healthy Living Activities Prompts, health intentions that predict engagement in targeted activities.	Intention scale for healthy activities use (iPad discussion sessions, website use including games; mConnect use) 10-Item Likert	T2 (month 1-2/mConnect intervention period)
Use of Healthy Living Activities Prompts, health intentions that predict engagement in targeted activities.	Intention scale for healthy activities use (iPad discussion sessions, website use including games; mConnect use) 10-Item Likert	T3 (month 3-4/mConnect intervention period)
Beck Depression Inventory-II (BDI-II)	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	T3 (4 months: change from T0/baseline)
Health Survey SF-12v2 (predicts future health services use).	Physical and mental health status from each person's perspective. 7-Item Likert	T3 (4 months: change from T0/baseline)
Quality of Life (Cantril Ladder)	Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert	T3 (4 months: change from T0/baseline)
Health Survey SF-12v2 (predicts future health services use).	Physical and mental health status from each person's perspective. 7-Item Likert	T4 (8 months: change from T3/4 months)
Quality of Life (Cantril Ladder)	Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert	T4 (8 months: change from T3/4 months)
Beck Depression Inventory-II (BDI-II)	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	T4 (8 months: change from T3/4 months)
Health Survey SF-12v2 (predicts future health services use).	Physical and mental health status from each person's perspective. 7-Item Likert	T5 (12 months: change from T4/8 months)
Quality of Life (Cantril Ladder)	Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert	T5 (12 months: change from T4/8 months)
Beck Depression Inventory-II (BDI-II)	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	T5 (12 months: change from T4/8 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preparedness (measures skills needed for independent HPN home care).	Ability to manage home-care; low score = needs home care assistance. 8-Item Likert	T0 (baseline data collection)
COOPS Social Support Scale	Ratings on having others who help, listen & provide tangible assistance support. 13-Item Likert	T0 (baseline data collection)
Preparedness (measures skills needed for independent HPN home care).	Ability to manage home-care; low score = needs home care assistance. 8-Item Likert	T3 (4 months: change from T0/baseline)
COOPS Social Support Scale	Ratings on having others who help, listen & provide tangible assistance support. 13-Item Likert	T3 (4 months: change from T0/baseline)
Mobile Care Helpfulness & Willingness-to-Pay Fees for Distance Health.	Rating of Helpfulness and willingness to pay for mobile care delivery. 10-Item Likert	T4 (8 months)
Preparedness (measures skills needed for independent HPN home care).	Ability to manage home-care; low score = needs home care assistance. 8-Item Likert	T4 (8 months: change from T3/4 months)
COOPS Social Support Scale	Ratings on having others who help, listen & provide tangible assistance support. 13-Item Likert	T4 (8 months: change from T3/4 months)
Preparedness (measures skills needed for independent HPN home care).	Ability to manage home-care; low score = needs home care assistance. 8-Item Likert	T5 (12 months: change from T4/8 months)
COOPS Social Support Scale	Ratings on having others who help, listen & provide tangible assistance support. 13-Item Likert	T5 (12 months: change from T4/8 months)

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Carol E Smith, RN, PhD, FAAN, University Of Kansas Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: December 6, 2016
• First Submitted That Met QC Criteria: December 8, 2016
• First Posted (Estimate): December 9, 2016

Study Record Updates

• Last Update Posted (Actual): December 2, 2020
• Last Update Submitted That Met QC Criteria: November 30, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: telemedicine; telehealth; Home Parenteral Nutrition; SBS; TPN; HPN; Total Parenteral Nutrition; short bowel disorder; mConnect
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Metabolic Diseases; Postoperative Complications; Gastrointestinal Diseases; Nutrition Disorders; Intestinal Diseases; Malnutrition; Malabsorption Syndromes; Short Bowel Syndrome
• Other Study ID Numbers: STUDY00004067; R01NR015743-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All data is de-identified and will be reported only in aggregate.