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Technology-Enabled Collaborative Care for Youth (TECC-Y)

Primary Purpose

Psychosis, Metabolic Disease, Cardiovascular Risk Factor

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Low Intensity Intervention
High Intensity Intervention
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Psychosis

Eligibility Criteria

16 Years - 29 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ages 16 - 29 years
  • Clinician diagnosis of early psychosis (diagnosed in last 5 years)
  • Prescribed psychiatric medication, stable for 4 weeks
  • Access to telephone or internet through computer or mobile

Exclusion Criteria:

  • Unable to provide consent
  • Unable to understand English

Sites / Locations

  • Centre for Addiction and Mental Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Low Intensity Intervention

High Intensity Intervention

Arm Description

The comparison group (low intensity) receives access to the e-platform and given an educational package with information about nutrition, physical activity, and smoking based on the NAVIGATE program (Mueser et al., 2015); i.e., a comprehensive program for implementing coordinated speciality care) with weekly e-mail reminders for 12 weeks. Participants receive access to online resources and free online webinars about these healthy behaviours.

The intervention group (high intensity) receives a technology-enabled CCM intervention. Participants receive access to an online platform and infographic modules to learn more about nutrition, physical activity, and smoking cessation. Also, they are assigned a personal health coach who collaboratively schedules weekly virtual sessions via the platform to discuss the educational materials, goal setting and motivation, and provide support in the 12-week program. The participant's health coach reviews the participant's concerns and goals weekly with a virtual care team (VCT; including a psychiatrist, addictions specialist, nutrition specialist, peer mentor, and recreational therapist), who provides individualized recommendations to include in the participant's treatment plan. Participants have access to online resources and online webinars about nutrition, physical activity and smoking.

Outcomes

Primary Outcome Measures

Change in patient engagement
The primary outcome is patient engagement will be defined as participant activation in the program measured via self-report levels of perceived benefit from the program.

Secondary Outcome Measures

Healthy Behaviour Change
The secondary outcome is to explore whether a CCM will help facilitate healthy behavioral changes in physical activity, nutrition, and smoking.

Full Information

First Posted
July 16, 2018
Last Updated
July 13, 2020
Sponsor
Centre for Addiction and Mental Health
Collaborators
Medical Psychiatry Alliance, Trillium Health Centre, The Hospital for Sick Children, University of Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT03610087
Brief Title
Technology-Enabled Collaborative Care for Youth
Acronym
TECC-Y
Official Title
Technology-Enabled Collaborative Care for Youth (TECC-Y): A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
July 25, 2018 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
Medical Psychiatry Alliance, Trillium Health Centre, The Hospital for Sick Children, University of Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The overall objective is to develop scalable interventions to address the physical health needs of patients affected by early psychosis. The objective of this project is to conduct a feasibility study of a high intensity technology-enabled collaborative care model (CCM) compared to lower intensity self-help modules and email support for early identification and treatment of cardio-metabolic risk factors in youth, ages 16-29, affected by early psychosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis, Metabolic Disease, Cardiovascular Risk Factor

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Intensity Intervention
Arm Type
Other
Arm Description
The comparison group (low intensity) receives access to the e-platform and given an educational package with information about nutrition, physical activity, and smoking based on the NAVIGATE program (Mueser et al., 2015); i.e., a comprehensive program for implementing coordinated speciality care) with weekly e-mail reminders for 12 weeks. Participants receive access to online resources and free online webinars about these healthy behaviours.
Arm Title
High Intensity Intervention
Arm Type
Experimental
Arm Description
The intervention group (high intensity) receives a technology-enabled CCM intervention. Participants receive access to an online platform and infographic modules to learn more about nutrition, physical activity, and smoking cessation. Also, they are assigned a personal health coach who collaboratively schedules weekly virtual sessions via the platform to discuss the educational materials, goal setting and motivation, and provide support in the 12-week program. The participant's health coach reviews the participant's concerns and goals weekly with a virtual care team (VCT; including a psychiatrist, addictions specialist, nutrition specialist, peer mentor, and recreational therapist), who provides individualized recommendations to include in the participant's treatment plan. Participants have access to online resources and online webinars about nutrition, physical activity and smoking.
Intervention Type
Behavioral
Intervention Name(s)
Low Intensity Intervention
Intervention Description
Participants will have access via the online platform to the NAVIGATE self-help modules for physical activity, nutrition and quitting smoking with a list of community resources. Subjects will be sent a standard reminder emails once per week to complete their modules and connect with their main provider for any assistance.
Intervention Type
Behavioral
Intervention Name(s)
High Intensity Intervention
Other Intervention Name(s)
TECC-Y
Intervention Description
Participants will receive individualized treatment planning, in collaboration with a Care Coordinator, and the Virtual Care Team (VCT). Interactive modules on physical activity, nutrition and quitting smoking will be provided via the online platform. the virtual team will be engaged to provide treatment and/or recommendations regarding the following: increasing physical activity, improving nutrition and diet, smoking cessation (psychosocial support plus medications), and medication adherence. Participants in this arm will have weekly check-ins with their assigned Care Coordinator where they will be able to discuss VCT recommendations, and progress on their goals.
Primary Outcome Measure Information:
Title
Change in patient engagement
Description
The primary outcome is patient engagement will be defined as participant activation in the program measured via self-report levels of perceived benefit from the program.
Time Frame
Baseline, 6-weeks, 12-weeks, and 24-weeks.
Secondary Outcome Measure Information:
Title
Healthy Behaviour Change
Description
The secondary outcome is to explore whether a CCM will help facilitate healthy behavioral changes in physical activity, nutrition, and smoking.
Time Frame
Baseline, 6-weeks, 12-weeks, and 24-weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ages 16 - 29 years Clinician diagnosis of early psychosis (diagnosed in last 5 years) Prescribed psychiatric medication, stable for 4 weeks Access to telephone or internet through computer or mobile Exclusion Criteria: Unable to provide consent Unable to understand English
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T1P7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32748501
Citation
Selby P, Vojtila L, Ashfaq I, Dragonetti R, Melamed OC, Carriere R, LaChance L, Kohut SA, Hahn M, Mulsant BH. Technology-enabled collaborative care for youth with early psychosis: A protocol for a feasibility study to improve physical health behaviours. Early Interv Psychiatry. 2021 Aug;15(4):828-836. doi: 10.1111/eip.13018. Epub 2020 Aug 3.
Results Reference
derived

Learn more about this trial

Technology-Enabled Collaborative Care for Youth

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