Medication Overuse Headache (MOH) and an Innovative Approach

NCT02435056 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 690

Last updated 2015-05-06

No results posted yet for this study

Summary

Appropriate delivery of quality healthcare requires constant monitoring of the patient during follow up, particularly in the presence of chronic diseases. This approach can be further improved if leading edge tools supporting diagnosis, as well as prediction, identification and monitoring of adverse events are available. COMOESTAS aims to develop an innovative Information Communications Technology (ICT) system that allows patients with a chronic condition to receive continuous and personalized treatment. The whole system is based on an advanced, "all in one" Alerting and Decision Support System that follows patients from the diagnosis and supports the physician in managing the therapy, controlling relevant events impacting on patient safety and activating specific procedures if selected thresholds are exceeded. In the frame of chronic neurological disorders, Medication Overuse Headache (MOH) is a common condition and a major cause of disability. MOH is curable, but its outcome is hampered by a high risk of relapse. It is, therefore, a perfect example of a disorder that can benefit from an ICT-assisted approach developing innovative systems and services for monitoring chronic conditions. COMOESTAS goals will be achieved by improving and integrating the traditional paper headache diaries and calendars into an innovative ICT tool taking into account the complex issues that accompany this peculiar form of headache, which will make the patient a key node in the entire process.

Conditions

  • Medication Overuse Headache

Interventions

OTHER

IEPR Approach

Adoption of Interactive Electronic Patient Record (IEPR) that consists of the following clinically-relevant main components: * Minimum Data Set for supporting the diagnosis * Electronic Diary with associated alerting system for monitoring the patient during the follow-up period * Second opinion system for improving the management

Sponsors & Collaborators

  • IRCCS National Neurological Institute "C. Mondino" Foundation

    lead OTHER

Principal Investigators

  • Giuseppe Nappi, MD · IRCCS Fondazione Istituto Neurologico Nazionale C. Mondino, Pavia, ITALY

  • Rigmor Jensen, MD, PhD · Glostrup Hospital, Copenaghen, Denmark

  • Zaza Katsarava, MD, PHD, MSc · Universitaetsklinikum, Essen, Germany

  • Jorge Leston, MD · Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia, Argentina

  • Ricardo Fadic, MD · Pontificia Universidad Catolica de Chile

  • Miguel JA Lainez, MD, PhD · Fundacion de la Comunidad Valenciana para la Investigacion Biomedica, la Docencia Y la Cooperacion Internacional y para el Desarrollo del Hospital Clinico Universitario De Valencia, Spain

  • Marco Pagani, Manager · Consorzio di Bioingegneria Medica, Pavia, Italy

  • Nestor Gorini · Ministerio de la Salud de la Provincia de Buenos Aires, Argentina

  • Santiago Spadafora · Fundacion Isalud, Buenos Aires, Argentina

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2009-07-31
Completion
2010-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02435056 on ClinicalTrials.gov