Technology-Enabled Collaborative Care for Youth

Cardiovascular Risk Factor Clinical Trial

— TECC-Y  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03610087
• Other study ID #: 121-2017
• Status: Completed
• Phase: N/A
• Start date: July 25, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2020
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Metabolic Disease
• Metabolic Diseases
• Psychosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario

Sponsors (5)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health	Medical Psychiatry Alliance, The Hospital for Sick Children, Trillium Health Centre, University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 6-weeks, 12-weeks, and 24-weeks.
Secondary	Healthy Behaviour Change	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.