Clinical trial NCT01701791: Telemedicine for Depression in Primary Care
Official title: The Efficacy of Telemedicine for Improving Depression Outcomes in Primary Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: Depression
Primary care
Computerized decision support system
General practitioner
Lead sponsor: IRCCS Centro San Giovanni di Dio Fatebenefratelli
Sponsor class: OTHER
First posted: 2012-10-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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: 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.


Eligibility 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.

Primary outcomes:
measure: Proportion of patients reaching remission
timeFrame: 6 months
Secondary outcomes:
measure: Number of GP appointments actually attended during follow-up
timeFrame: 6 months
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Health Telematic Network srl
city: Brescia
country: Italy
facility: IRCCS Centro San Giovanni di Dio Fatebenefratelli
city: Udine
country: Italy
facility: Dipartimento di Scienze Mediche Sperimentali e Cliniche, Università di Udine
city: Urbino
country: Italy
facility: Marco B. Rocchi
Study officials:
affiliation: IRCCS Centro San Giovanni di Dio Fatebenefratelli
name: Matteo Balestrieri, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Balestrieri M, Sisti D, Rocchi M, Rucci P, Simon G, Araya R, de Girolamo G. Effectiveness of clinical decision support systems and telemedicine on outcomes of depression: a cluster randomized trial in general practice. Fam Pract. 2020 Nov 28;37(6):731-737. doi: 10.1093/fampra/cmaa077.