Technology-Enabled Collaborative Care for Youth

Not Applicable

Completed

• Conditions: Metabolic Disease; Psychosis; Cardiovascular Risk Factor
• Interventions: Behavioral: High Intensity Intervention; Behavioral: Low Intensity Intervention

• Registration Number: NCT03610087
• Lead Sponsor: Centre for Addiction and Mental Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-16
• Study Start: 2018-07-25
• Study First Submitted QC: 2018-07-25
• Study First Posted: 2018-08-01
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-13
• Last Update Posted: 2020-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Intensity Intervention	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.
Low Intensity Intervention	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.

Primary Outcome Measures

Name	Time	Method
Change in patient engagement	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.

Secondary Outcome Measures

Name	Time	Method
Healthy Behaviour Change	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.

Trial Locations

Locations (1)

Centre for Addiction and Mental Health; 🇨🇦 Toronto, Ontario, Canada