Telemedicine for Depression in Primary Care
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|ClinicalTrials.gov Identifier: NCT01701791|
Recruitment Status : Unknown
Verified February 2016 by Giovanni de Girolamo, M.D., IRCCS Centro San Giovanni di Dio Fatebenefratelli.
Recruitment status was: Active, not recruiting
First Posted : October 5, 2012
Last Update Posted : February 24, 2016
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 or disease||Intervention/treatment||Phase|
|Depression||Other: Computerized Decision Support System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Efficacy of Telemedicine for Improving Depression Outcomes in Primary Care|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||January 2016|
|Estimated Study Completion Date :||May 2016|
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.
- 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.
- Number of GP appointments actually attended during follow-up [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01701791
|Health Telematic Network srl|
|Brescia, Italy, 25125|
|IRCCS Centro San Giovanni di Dio Fatebenefratelli|
|Brescia, Italy, 25125|
|Dipartimento di Scienze Mediche Sperimentali e Cliniche, Università di Udine|
|Udine, Italy, 33100|
|Marco B. Rocchi|
|Principal Investigator:||Matteo Balestrieri, M.D.||IRCCS Centro San Giovanni di Dio Fatebenefratelli|