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

Study Overview
=================
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.

Official Title
-----------------
Teen Connections for Support From Multidisciplinary Professionals & Peers

Conditions
-----------------
Malabsorption, Short Bowel Syndrome, Malnutrition

Intervention / Treatment
-----------------
* Behavioral: mConnect plus mobile connections to multidisciplinary professionals & peers
* Behavioral: iPad use plus one mobile connections to multidisciplinary professionals & peers


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HPN, Home Parenteral Nutrition, Total Parenteral Nutrition, TPN, mConnect, SBS, short bowel disorder, telehealth, telemedicine