Telemedicine for Depression in Primary Care

February 23, 2016 updated by: Giovanni de Girolamo, M.D., IRCCS Centro San Giovanni di Dio Fatebenefratelli

The Efficacy of Telemedicine for Improving Depression Outcomes in Primary Care

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

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

  • Italy
      • Brescia, Italy, 25125
        • Health Telematic Network srl
      • Brescia, Italy, 25125
        • IRCCS Centro San Giovanni di Dio Fatebenefratelli
      • Udine, Italy, 33100
        • Dipartimento di Scienze Mediche Sperimentali e Cliniche, Università di Udine
      • Urbino, Italy
        • Marco B. Rocchi

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Computerized Decision Support System (CDSS)
GPs will use a CDSS with treatment algorithms, supervision from a consultant psychiatrist, and despatch to patients of reminders via mobile texting or automatic mobile (or landline) phone calls to improve adherence to the treatment prescribed.
Other: Computerized Decision Support System
No Intervention: Treatment as usual
GPs will provide TAU, will make their own decisions and will therefore not use the CDSS. Patients will not receive any reminders.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients reaching remission
Time Frame: 6 months
The primary end-point will be the proportion of patients reaching remission by 6 months, as represented by an exit IDS-SR score of <or=12.
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of GP appointments actually attended during follow-up
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Investigators

  • Principal Investigator: Matteo Balestrieri, M.D., IRCCS Centro San Giovanni di Dio Fatebenefratelli

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

Helpful Links

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

November 1, 2012

Primary Completion (Actual)

January 1, 2016

Study Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

October 3, 2012

First Submitted That Met QC Criteria

October 3, 2012

First Posted (Estimate)

October 5, 2012

Study Record Updates

Last Update Posted (Estimate)

February 24, 2016

Last Update Submitted That Met QC Criteria

February 23, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RF-2010-2316063

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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