Standardized Educational Plan for Epilepsy Patients With Comorbidities

NCT01804322 | Completed Phase 4 DMC

• 1 other identifier: FARM77RW2S
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 1

Brief Summary

Epilepsy requires long-term drug treatment and is frequently associated with other clinical conditions. Combinations of antiepileptic drugs and other compounds are fairly common and increase with age. Adverse drug reactions and drug interactions are expected and may affect compliance, particularly in patients not receiving adequate information. Primary objective of the study is to verify if a comprehensive and standardized educational plan is followed by a significant reduction of the number of adult patients with epilepsy and comorbidity presenting clinically relevant adverse treatment effects. Secondary objectives include effects on number of adverse treatment events, health-related quality of life (HRQOL), direct medical costs, and patient's compliance. The study is a randomized, controlled, open-label, pragmatic trial. Included are consecutive adult outpatients with 1+ concurrent clinical conditions on chronic treatment and at least one clinically relevant treatment-related adverse event and/or clinically relevant drug interaction. Eligible patients will be randomized to receive a comprehensive and standardized educational plan (experimental arm) or to usual care, ie management of adverse event/drug interaction as done in clinical practice (control arm). The experimental plan consists in discussing with patient and caregiver the cause and nature of adverse event/drug interaction, the tolerability profile of each drug, the clinical manifestations associated with current drug interaction(s), contraindications of potentially interfering over-the-counter drugs, indications and benefits of suggested treatment changes, and withdrawal of potentially interfering, contraindicated or ineffective drugs. All patients will be seen at one, three and six months after admission. Expected results: The number of patients free from clinically relevant adverse treatment events and/or drug interactions in each treatment arm at end of study is expected to be higher in patients assigned to comprehensive and standardized educational plan compared to usual care (primary outcome). Patients on the experimental plan are also expected to be more commonly free from relevant adverse events and/or drug interactions at each intermediate visit, to present a lower number of adverse treatment events, to imply lower costs for medical contacts, hospital admissions, and drugs, to present better HRQOL scores, and to present less weekly treatment omissions.

Conditions

Epilepsy

Keywords

epilepsy; chronic comorbidities; educational strategies; drug interactions; drug adverse effects

Outcome Measures

Primary Outcomes (1)

• The primary outcome is defined by the number of patients free from clinically relevant adverse treatment events and/or drug interactions in each treatment arm at end of study.

  6 months

Secondary Outcomes (3)

• The mean and median number of adverse treatment events in each treatment arm, at each intermediate visit and at end of study

  6 months

• Total HRQOL summary score changes (comparing last follow-up to admission visit

  6 months

• The mean and median number of drug interactions in each treatment arm, at each intermediate visit and at end of study

  6 months

Other Outcomes (1)

• The monetary costs of medical contacts, hospital admissions, and drugs; the one-hour meetings with patients assigned to the experimental arm will be included in the costs

  6 months

Study Arms (2)

Usual care

ACTIVE COMPARATOR

usual care according to the practice of participating Epilepsy Centers

Other: usual care

Standardized educational plan

EXPERIMENTAL

The comprehensive and standardized educational plan consists in the discussion with the patient each of the following points: * The cause and nature of the adverse event and/or drug interaction * The tolerability profile of each drug present in the schedule * The clinical manifestations associated with the current drug interactions * Any contraindication to the use of over-the-counter drugs potentially interfering with the current treatment schedule * The reasons for and the potential benefits of the suggested treatment change * An encouragement to withdraw any potentially interfering or contraindicated drug

Other: Standardized educational plan

Interventions

Standardized educational plan OTHER

The comprehensive and standardized educational plan consists in the discussion with the patient each of the following points: * The cause and nature of the adverse event and/or drug interaction * The tolerability profile of each drug present in the schedule * The clinical manifestations associated with the current drug interactions * Any contraindication to the use of over-the-counter drugs potentially interfering with the current treatment schedule * The reasons for and the potential benefits of the suggested treatment change * An encouragement to withdraw any potentially interfering or contraindicated drug

Standardized educational plan

usual care OTHER

usual care according to the participating Epilepsy Centers

Usual care

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older
• Presence of one or more concurrent clinical conditions requiring chronic treatment (ie, daily treatment lasting one month or longer)
• At least one clinically relevant adverse event attributable to the present treatment(s) and/or a clinically relevant drug interaction; for the purposes of this study, a clinically relevant adverse event is any symptom and/or clinical and/or laboratory sign requiring treatment change; a clinically relevant drug interaction is an interaction requiring active monitoring and/or treatment change
• The treatment schedule can be modified to eliminate adverse event(s) and/or risky drug interactions; the decision to modify the treatment is left to the caring physician's judgment

You may not qualify if:

• Age younger than 18 years
• Absence of concurrent chronic treatments
• Presence of polytherapy with AEDs unassociated to treatments for concurrent (non-epileptic) disorders
• The treatment schedule cannot be changed even at the presence of clinically relevant adverse events
• Patient or caregiver is unwilling to release a written informed consent

Sponsors & Collaborators

• San Gerardo Hospital: lead
• Agenzia Italiana del Farmaco: collaborator

Study Sites (1)

Azienda Ospedaliera San Gerardo, Central Contact (9 recruting centers)

Monza, MB, 20900, Italy

Location

Related Publications (1)

• Beretta S, Beghi E, Messina P, Gerardi F, Pescini F, La Licata A, Specchio L, Ferrara M, Canevini MP, Turner K, La Briola F, Franceschetti S, Binelli S, Giglioli I, Galimberti CA, Fattore C, Zaccara G, Tramacere L, Sasanelli F, Pirovano M, Ferrarese C. Comprehensive educational plan for patients with epilepsy and comorbidity (EDU-COM): a pragmatic randomised trial. J Neurol Neurosurg Psychiatry. 2014 Aug;85(8):889-94. doi: 10.1136/jnnp-2013-306553. Epub 2014 Jan 8.

  PMID: 24403284 DERIVED

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Simone Beretta, MD, PhD

  Azienda Ospedaliera San Gerardo Monza

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Research Neurologist (Study Coordinator)

Study Record Dates

• First Submitted: March 1, 2013
• First Posted: March 5, 2013
• Study Start: February 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: September 1, 2012
• Last Updated: March 6, 2013

Record last verified: 2013-03

Locations

IT (1)