Ignite Creation Date:
2024-05-06 @ 1:00 AM
Last Modification Date:
2024-10-26 @ 10:57 AM
Study NCT ID:
NCT01701791
Status:
UNKNOWN
Last Update Posted:
2016-02-24
First Post:
2012-10-03
Brief Title:
Telemedicine for Depression in Primary Care
Sponsor:
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Organization:
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Study Overview
Official Title:
The Efficacy of Telemedicine for Improving Depression Outcomes in Primary Care
Status:
UNKNOWN
Status Verified Date:
2016-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 1To develop and employ computer-based assessment to more accurately and timely detect patient depression in PC settings 2To 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 2aTo support GP decisions with treatment algorithms and improve the quality of GP and mental health service collaboration 2bTo 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
Aims 1To develop and employ computer-based assessment to more accurately and timely detect patient depression in PC settings 2To 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 2aTo support GP decisions with treatment algorithms and improve the quality of GP and mental health service collaboration 2bTo 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None