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

NCT02987569 | Completed DMC

• 2 other identifiers: STUDY00004067R01NR015743-01A1
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Short Bowel Syndrome; Malabsorption; Malnutrition

Keywords

Home Parenteral Nutrition; HPN; Total Parenteral Nutrition; TPN; mConnect; SBS; short bowel disorder; telehealth; telemedicine

Outcome Measures

Primary Outcomes (14)

• 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 Outcomes (9)

• Preparedness (measures skills needed for independent HPN home care).

  T0 (baseline data collection)

• COOPS Social Support Scale

  T0 (baseline data collection)

• Preparedness (measures skills needed for independent HPN home care).

  T3 (4 months: change from T0/baseline)

• COOPS Social Support Scale

  T3 (4 months: change from T0/baseline)

• Mobile Care Helpfulness & Willingness-to-Pay Fees for Distance Health.

  T4 (8 months)

Study Arms (2)

Group One

EXPERIMENTAL

Intervention

Behavioral: mConnect plus mobile connections to multidisciplinary professionals & peers

Group Two

ACTIVE COMPARATOR

Control

Behavioral: iPad use plus one mobile connections to multidisciplinary professionals & peers

Interventions

mConnect plus mobile connections to multidisciplinary professionals & peers BEHAVIORAL

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.

Group One

iPad use plus one mobile connections to multidisciplinary professionals & peers BEHAVIORAL

iPad with a data plan and one professionally moderated iPad visual meeting with peers.

Group Two

Eligibility Criteria

• Age: 13 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Enteral nutrition dependency only
• Less than 13 years of age
• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related 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.

  PMID: 29016235 BACKGROUND

MeSH Terms

Conditions

Short Bowel Syndrome; Malabsorption Syndromes; Malnutrition; Hyperphagia

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Metabolic Diseases; Nutritional and Metabolic Diseases; Nutrition Disorders; Signs and Symptoms, Digestive; Signs and Symptoms

Study Officials

• Carol E Smith, RN, PhD, FAAN

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 9, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: June 1, 2020
• Last Updated: December 2, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)