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

Primary Purpose

Short Bowel Syndrome, Malabsorption, Malnutrition

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mConnect plus mobile connections to multidisciplinary professionals & peers
iPad use plus one mobile connections to multidisciplinary professionals & peers
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Short Bowel Syndrome focused on measuring Home Parenteral Nutrition, HPN, Total Parenteral Nutrition, TPN, mConnect, SBS, short bowel disorder, telehealth, telemedicine

Eligibility Criteria

13 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group One

Group Two

Arm Description

Intervention

Control

Outcomes

Primary Outcome Measures

Health Survey SF-12v2 (predicts future health services use).
Physical and mental health status from each person's perspective. 7-Item Likert
Quality of Life (Cantril Ladder)
Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert
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
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
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
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
Health Survey SF-12v2 (predicts future health services use).
Physical and mental health status from each person's perspective. 7-Item Likert
Quality of Life (Cantril Ladder)
Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert
Health Survey SF-12v2 (predicts future health services use).
Physical and mental health status from each person's perspective. 7-Item Likert
Quality of Life (Cantril Ladder)
Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert
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
Health Survey SF-12v2 (predicts future health services use).
Physical and mental health status from each person's perspective. 7-Item Likert
Quality of Life (Cantril Ladder)
Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert
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

Secondary Outcome Measures

Preparedness (measures skills needed for independent HPN home care).
Ability to manage home-care; low score = needs home care assistance. 8-Item Likert
COOPS Social Support Scale
Ratings on having others who help, listen & provide tangible assistance support. 13-Item Likert
Preparedness (measures skills needed for independent HPN home care).
Ability to manage home-care; low score = needs home care assistance. 8-Item Likert
COOPS Social Support Scale
Ratings on having others who help, listen & provide tangible assistance support. 13-Item Likert
Mobile Care Helpfulness & Willingness-to-Pay Fees for Distance Health.
Rating of Helpfulness and willingness to pay for mobile care delivery. 10-Item Likert
Preparedness (measures skills needed for independent HPN home care).
Ability to manage home-care; low score = needs home care assistance. 8-Item Likert
COOPS Social Support Scale
Ratings on having others who help, listen & provide tangible assistance support. 13-Item Likert
Preparedness (measures skills needed for independent HPN home care).
Ability to manage home-care; low score = needs home care assistance. 8-Item Likert
COOPS Social Support Scale
Ratings on having others who help, listen & provide tangible assistance support. 13-Item Likert

Full Information

First Posted
December 6, 2016
Last Updated
November 30, 2020
Sponsor
University of Kansas Medical Center
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT02987569
Brief Title
Teen and Young Adult Connections for Support From Multidisciplinary Professionals & Peers
Official Title
Teen Connections for Support From Multidisciplinary Professionals & Peers
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
June 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Short Bowel Syndrome, Malabsorption, Malnutrition
Keywords
Home Parenteral Nutrition, HPN, Total Parenteral Nutrition, TPN, mConnect, SBS, short bowel disorder, telehealth, telemedicine

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group One
Arm Type
Experimental
Arm Description
Intervention
Arm Title
Group Two
Arm Type
Active Comparator
Arm Description
Control
Intervention Type
Behavioral
Intervention Name(s)
mConnect plus mobile connections to multidisciplinary professionals & peers
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
iPad use plus one mobile connections to multidisciplinary professionals & peers
Intervention Description
iPad with a data plan and one professionally moderated iPad visual meeting with peers.
Primary Outcome Measure Information:
Title
Health Survey SF-12v2 (predicts future health services use).
Description
Physical and mental health status from each person's perspective. 7-Item Likert
Time Frame
T0 (baseline data collection)
Title
Quality of Life (Cantril Ladder)
Description
Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert
Time Frame
T0 (baseline data collection)
Title
Beck Depression Inventory-II (BDI-II)
Description
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
Time Frame
T0 (baseline data collection)
Title
Use of Healthy Living Activities Prompts, health intentions that predict engagement in targeted activities.
Description
Intention scale for healthy activities use (iPad discussion sessions, website use including games; mConnect use) 10-Item Likert
Time Frame
T2 (month 1-2/mConnect intervention period)
Title
Use of Healthy Living Activities Prompts, health intentions that predict engagement in targeted activities.
Description
Intention scale for healthy activities use (iPad discussion sessions, website use including games; mConnect use) 10-Item Likert
Time Frame
T3 (month 3-4/mConnect intervention period)
Title
Beck Depression Inventory-II (BDI-II)
Description
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
Time Frame
T3 (4 months: change from T0/baseline)
Title
Health Survey SF-12v2 (predicts future health services use).
Description
Physical and mental health status from each person's perspective. 7-Item Likert
Time Frame
T3 (4 months: change from T0/baseline)
Title
Quality of Life (Cantril Ladder)
Description
Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert
Time Frame
T3 (4 months: change from T0/baseline)
Title
Health Survey SF-12v2 (predicts future health services use).
Description
Physical and mental health status from each person's perspective. 7-Item Likert
Time Frame
T4 (8 months: change from T3/4 months)
Title
Quality of Life (Cantril Ladder)
Description
Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert
Time Frame
T4 (8 months: change from T3/4 months)
Title
Beck Depression Inventory-II (BDI-II)
Description
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
Time Frame
T4 (8 months: change from T3/4 months)
Title
Health Survey SF-12v2 (predicts future health services use).
Description
Physical and mental health status from each person's perspective. 7-Item Likert
Time Frame
T5 (12 months: change from T4/8 months)
Title
Quality of Life (Cantril Ladder)
Description
Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert
Time Frame
T5 (12 months: change from T4/8 months)
Title
Beck Depression Inventory-II (BDI-II)
Description
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
Time Frame
T5 (12 months: change from T4/8 months)
Secondary Outcome Measure Information:
Title
Preparedness (measures skills needed for independent HPN home care).
Description
Ability to manage home-care; low score = needs home care assistance. 8-Item Likert
Time Frame
T0 (baseline data collection)
Title
COOPS Social Support Scale
Description
Ratings on having others who help, listen & provide tangible assistance support. 13-Item Likert
Time Frame
T0 (baseline data collection)
Title
Preparedness (measures skills needed for independent HPN home care).
Description
Ability to manage home-care; low score = needs home care assistance. 8-Item Likert
Time Frame
T3 (4 months: change from T0/baseline)
Title
COOPS Social Support Scale
Description
Ratings on having others who help, listen & provide tangible assistance support. 13-Item Likert
Time Frame
T3 (4 months: change from T0/baseline)
Title
Mobile Care Helpfulness & Willingness-to-Pay Fees for Distance Health.
Description
Rating of Helpfulness and willingness to pay for mobile care delivery. 10-Item Likert
Time Frame
T4 (8 months)
Title
Preparedness (measures skills needed for independent HPN home care).
Description
Ability to manage home-care; low score = needs home care assistance. 8-Item Likert
Time Frame
T4 (8 months: change from T3/4 months)
Title
COOPS Social Support Scale
Description
Ratings on having others who help, listen & provide tangible assistance support. 13-Item Likert
Time Frame
T4 (8 months: change from T3/4 months)
Title
Preparedness (measures skills needed for independent HPN home care).
Description
Ability to manage home-care; low score = needs home care assistance. 8-Item Likert
Time Frame
T5 (12 months: change from T4/8 months)
Title
COOPS Social Support Scale
Description
Ratings on having others who help, listen & provide tangible assistance support. 13-Item Likert
Time Frame
T5 (12 months: change from T4/8 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol E Smith, RN, PhD, FAAN
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
All data is de-identified and will be reported only in aggregate.
Citations:
PubMed Identifier
29016235
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.
Results Reference
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Teen and Young Adult Connections for Support From Multidisciplinary Professionals & Peers

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