Telemedicine for Depression in Primary Care

This study is not yet open for participant recruitment.
Verified October 2012 by IRCCS Centro San Giovanni di Dio Fatebenefratelli
Sponsor:
Information provided by (Responsible Party):
Giovanni de Girolamo, M.D., IRCCS Centro San Giovanni di Dio Fatebenefratelli
ClinicalTrials.gov Identifier:
NCT01701791
First received: October 3, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

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.

Condition Intervention
Depression
Other: Computerized Decision Support System

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Efficacy of Telemedicine for Improving Depression Outcomes in Primary Care

Resource links provided by NLM:


Further study details as provided by IRCCS Centro San Giovanni di Dio Fatebenefratelli:

Primary Outcome Measures:
  • Proportion of patients reaching remission [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of GP appointments actually attended during follow-up [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change in health related quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Change in EuroQOL (EQ-5D) scores


Estimated Enrollment: 400
Study Start Date: January 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01701791

Contacts
Contact: Giovanni de Girolamo, M.D. 00390303501590 gdegirolamo@fatebenefratelli.it

Locations
Italy
IRCCS Centro San Giovanni di Dio Fatebenefratelli Not yet recruiting
Brescia, Italy, 25125
Contact: Giovanni de Girolamo, M.D.    00390303501590    gdegirolamo@fatebenefratelli.it   
Principal Investigator: Giovanni de Girolamo, M.D.         
Health Telematic Network srl Active, not recruiting
Brescia, Italy, 25125
Dipartimento di Scienze Mediche Sperimentali e Cliniche, Università di Udine Not yet recruiting
Udine, Italy, 33100
Contact: Matteo Balestrieri, M.D.    00390432559627    matteo.balestrieri@uniud.it   
Principal Investigator: Matteo Balestrieri, Professor         
Marco B. Rocchi Active, not recruiting
Urbino, Italy
Sponsors and Collaborators
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Investigators
Principal Investigator: Matteo Balestrieri, M.D. IRCCS Centro San Giovanni di Dio Fatebenefratelli
  More Information

Additional Information:
No publications provided

Responsible Party: Giovanni de Girolamo, M.D., Scientific Director, IRCCS Centro San Giovanni di Dio Fatebenefratelli
ClinicalTrials.gov Identifier: NCT01701791     History of Changes
Other Study ID Numbers: RF-2010-2316063
Study First Received: October 3, 2012
Last Updated: October 3, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by IRCCS Centro San Giovanni di Dio Fatebenefratelli:
Depression
Primary care
Computerized decision support system
General practitioner

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014