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

July 13, 2020 updated by: Peter Selby, Centre for Addiction and Mental Health

Technology-Enabled Collaborative Care for Youth (TECC-Y): A Feasibility Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T1P7
        • Centre for Addiction and Mental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 29 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Low Intensity Intervention
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.
Behavioral: Low Intensity Intervention
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.
EXPERIMENTAL: High Intensity Intervention
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.
Behavioral: High Intensity Intervention
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.
Other Names:
  • TECC-Y

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in patient engagement
Time Frame: Baseline, 6-weeks, 12-weeks, and 24-weeks.
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.
Baseline, 6-weeks, 12-weeks, and 24-weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healthy Behaviour Change
Time Frame: Baseline, 6-weeks, 12-weeks, and 24-weeks.
The secondary outcome is to explore whether a CCM will help facilitate healthy behavioral changes in physical activity, nutrition, and smoking.
Baseline, 6-weeks, 12-weeks, and 24-weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre for Addiction and Mental Health

Collaborators

The Hospital for Sick Children
University of Toronto
Trillium Health Centre
Medical Psychiatry Alliance

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 25, 2018

Primary Completion (ACTUAL)

June 30, 2020

Study Completion (ACTUAL)

June 30, 2020

Study Registration Dates

First Submitted

July 16, 2018

First Submitted That Met QC Criteria

July 25, 2018

First Posted (ACTUAL)

August 1, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 15, 2020

Last Update Submitted That Met QC Criteria

July 13, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 121-2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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