Telemedicine for Depression in Primary Care

NCT01701791 | Unknown DMC

• 1 other identifier: RF-2010-2316063
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

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.

Conditions

Depression

Keywords

Depression; Primary care; Computerized decision support system; General practitioner

Outcome Measures

Primary Outcomes (1)

• Proportion of patients reaching remission

  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.

  6 months

Secondary Outcomes (1)

• Number of GP appointments actually attended during follow-up

  6 months

Study Arms (2)

Computerized Decision Support System (CDSS)

EXPERIMENTAL

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

Treatment as usual

NO INTERVENTION

GPs will provide TAU, will make their own decisions and will therefore not use the CDSS. Patients will not receive any reminders.

Interventions

Computerized Decision Support System OTHER

Computerized Decision Support System (CDSS)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Centro San Giovanni di Dio Fatebenefratelli: lead

Study Sites (4)

Health Telematic Network srl

Brescia, Brescia, 25125, Italy

Location

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Brescia, Brescia, 25125, Italy

Location

Dipartimento di Scienze Mediche Sperimentali e Cliniche, Università di Udine

Udine, Udine, 33100, Italy

Location

Marco B. Rocchi

Urbino, Italy

Location

Related Publications (1)

• 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.

  PMID: 32766705 DERIVED

Related Links

• Website of the Coordinating Centre

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Matteo Balestrieri, M.D.

  IRCCS Centro San Giovanni di Dio Fatebenefratelli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Director

Study Record Dates

• First Submitted: October 3, 2012
• First Posted: October 5, 2012
• Study Start: November 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: May 1, 2016
• Last Updated: February 24, 2016

Record last verified: 2016-02

Locations

IT (4)