Telemedicine for Depression in Primary Care

Depression Clinical Trial

Official title:

The Efficacy of Telemedicine for Improving Depression Outcomes in Primary Care

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01701791
• Other study ID #: RF-2010-2316063
• Status: Active, not recruiting
• Phase: N/A
• First received: October 3, 2012
• Last updated: February 23, 2016
• Start date: November 2012
• Est. completion date: May 2016

Study information

• Verified date: February 2016
• Source: IRCCS Centro San Giovanni di Dio Fatebenefratelli
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Background: In Italy, several recent studies found that a large percentage of patients attending Primary Care (PC) clinics meet criteria for at least one common mental disorder, as they show high rates of depression, anxiety, and co-morbid anxiety and depression. These patients may experience significant functional impairment and suffer from unexplained somatic symptoms, and often remain undetected and untreated. Consistent evidence for the effectiveness of organized care programs for depression, by improving quality of care and treatment adherence, is now available. Fundamental elements of these programs include algorithms to prompt the proper and timely implementation of evidence-based treatments, structured outcome assessment and systematic outreach. Telemedicine tools may represent a valuable strategy for improving depression outcomes in PC.

Aims: 1.To develop and employ computer-based assessment to more accurately and timely detect patient depression in PC settings; 2.To evaluate the feasibility and effectiveness of a care support program developed in conjunction with the PC-based assessment for patients suffering from depression, as based on two main objectives: 2a.To support GP decisions with treatment algorithms and improve the quality of GP and mental health service collaboration; 2b.To improve patient compliance and treatment adherence by using appropriate telecommunication tools and technologically advanced tools to conduct systematic routine assessment. Although much of this system will be computer-based, live telephonic and in-person contacts will also be included as needed.

Study Design: The study is a randomized controlled trial, involving four PC group clinics (GCs) located in two areas of Northern Italy. Two PC clinics will use the experimental protocol; the other two will serve as controls.

The study will compare two different conditions:

• Group 1 (experimental): GPs will use a Computer Decision Support System with treatment algorithms and advice and supervision from a consultant psychiatrist. Patients will receive reminders via mobile texting or automatic mobile (or landline) phone calls to improve adherence to the treatment prescribed.

• Group 2 (control): GPs will provide TAU, will make their own decisions and will therefore not use the CDSS. Patients will not receive any reminders. All enrolled patients will be administered and will fill in the IDS-SR at baseline, 3 and 6-months: the IDS-SR score will be used as a primary endpoint.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: May 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients aged 18-65 years

• PHQ-9 score of >or=14 at baseline

• IDS-SR score of >or=26 at baseline

• No filling of antidepressant medication prescription for 270 prior days

• Illiteracy or the lack of working telephone to receive reminders.

Exclusion Criteria:

• Current diagnosis of alcohol or substance dependence

• History of Bipolar Disorder determined by a baseline Composite International Diagnostic Interview (CIDI) screening scale of lifetime mania/hypomania

• Any current prescription for mood stabilizer or antipsychotic medication

• Female with positive pregnancy test

• General medical conditions which contraindicate antidepressant medications

• Clinical status requiring inpatient or day hospital treatment.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Other:
• Computerized Decision Support System

Locations

Country	Name	City	State
Italy	Health Telematic Network srl	Brescia
Italy	IRCCS Centro San Giovanni di Dio Fatebenefratelli	Brescia
Italy	Dipartimento di Scienze Mediche Sperimentali e Cliniche, Università di Udine	Udine
Italy	Marco B. Rocchi	Urbino

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Centro San Giovanni di Dio Fatebenefratelli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients reaching remission	The primary end-point will be the proportion of patients reaching remission by 6 months, as represented by an exit IDS-SR score of	6 months	No
Secondary	Number of GP appointments actually attended during follow-up		6 months	No

External Links

•   Website of the Coordinating Centre