Telemedicine for Depression 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 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|
- 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.
- Number of GP appointments actually attended during follow-up [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Change in health related quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]Change in EuroQOL (EQ-5D) scores
|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)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01701791
|Contact: Giovanni de Girolamo, M.D.||email@example.com|
|Health Telematic Network srl||Active, not recruiting|
|Brescia, Italy, 25125|
|IRCCS Centro San Giovanni di Dio Fatebenefratelli||Not yet recruiting|
|Brescia, Italy, 25125|
|Contact: Giovanni de Girolamo, M.D. 00390303501590 firstname.lastname@example.org|
|Principal Investigator: Giovanni de Girolamo, M.D.|
|Dipartimento di Scienze Mediche Sperimentali e Cliniche, Università di Udine||Not yet recruiting|
|Udine, Italy, 33100|
|Contact: Matteo Balestrieri, M.D. 00390432559627 email@example.com|
|Principal Investigator: Matteo Balestrieri, Professor|
|Marco B. Rocchi||Active, not recruiting|
|Principal Investigator:||Matteo Balestrieri, M.D.||IRCCS Centro San Giovanni di Dio Fatebenefratelli|