DepressionNCT01701791
Telemedicine for Depression in Primary Care
A study testing Computerized Decision Support System in people with Depression, run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 4 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Computerized Decision Support System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesItaly
- Study dates
- Nov 2012to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
Health Telematic Network srl
Brescia, Brescia, 25125
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Brescia, Brescia, 25125
Dipartimento di Scienze Mediche Sperimentali e Cliniche, Università di Udine
Udine, Udine, 33100
Marco B. Rocchi
Urbino
About this study
Official title: The Efficacy of Telemedicine for Improving Depression Outcomes 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.
Read more
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
- Being tested
- Computerized Decision Support System
- Keywords
- Depression, Primary care, Computerized decision support system, General practitioner
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Decision Support SystemOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Number of GP appointments actually attended during follow-up
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionJan 2016
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni de Girolamo, M.D., IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Investigators
- Matteo Balestrieri, M.D., Principal investigator, IRCCS Centro San Giovanni di Dio Fatebenefratelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01701791
- Sponsor's protocol ID
- RF-2010-2316063
- Status last verified
- Feb 2016
- First submitted
- 3 Oct 2012
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32766705
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Telemedicine for Improving Depression Outcomes in Primary Care
- ClinicalTrials.gov ID
- NCT01701791
- Acronym / sponsor ID
- RF-2010-2316063
- Conditions
- Depression
- Keywords
- Depression, Primary care, Computerized decision support system, General practitioner
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- IRCCS Centro San Giovanni di Dio FatebenefratelliUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- May 2016 (estimated)
- First posted
- 5 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computerized Decision Support System (CDSS) | Experimental | Other: Computerized Decision Support SystemGPs 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized Decision Support System | Other | Computerized Decision Support System (CDSS) |
Primary outcome
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.
1 secondary outcome
Number of GP appointments actually attended during follow-up
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2016.
- Derived from this study: PubMed 32766705Balestrieri 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.
- Website of the Coordinating CentreLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matteo Balestrieri, M.D. principal investigator
IRCCS Centro San Giovanni di Dio Fatebenefratelli
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized Decision Support System in people with Depression, run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients reaching remission (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01701791, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2016.