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

Malnutrition Clinical Trial

Official title:

Teen Connections for Support From Multidisciplinary Professionals & Peers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02987569
• Other study ID #: STUDY00004067
• Secondary ID: R01NR015743-01A1
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: June 2020

Study information

• Verified date: November 2020
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: June 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Malabsorption
• Malabsorption Syndromes
• Malnutrition
• Short Bowel Syndrome

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.
• iPad use plus one mobile connections to multidisciplinary professionals & peers
iPad with a data plan and one professionally moderated iPad visual meeting with peers.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	COOPS Social Support Scale	Ratings on having others who help, listen & provide tangible assistance support. 13-Item Likert	T0 (baseline data collection)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)