Contact information
Type
Scientific
Primary contact
Prof Martha Losada-Camacho
ORCID ID
Contact details
Crr 30 45-03 Edificio 450
Farmacia Oficina 215
Ciudad Universitaria
Bogotá
001
Colombia
+57 (0)1 3114445288
mlosadac@unal.edu.co
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
01-2010
Study information
Scientific title
Impact of pharmaceutical intervention in the treatment and quality of life of women with epilepsy: a randomised controlled pragmatic clinical trial
Acronym
IPHIWWE
Study hypothesis
Will the intervention of the pharmacist in the therapy of women with epilepsy to optimise treatment and improve their quality of life?
Ethics approval
Local medical ethics committee (Fundación Liga Central Contra la Epilepsia, sede Bogotá, LICCE, Acta 18/2009 Comité de Ética), 11/08/2009, ref: CEI-A1. Acta 18 de 2009
Study design
Randomised controlled pragmatic trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Epilepsy
Intervention
This is a two-armed pragmatic trial. The intervention group will receive usual medical care and are additionally given pharmaceutical care, health education and therapeutic drugs monitoring for six months. The control group continued with standard medical care.
All the patients continued drug treatment prescribed by the physician. Questionnaire measures will be administered to all participants at the beginning of baseline recording and at the end of the study.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Quality of Life in Epilepsy Inventory-31 (QOLIE-31). Questionnaire measures will be administered to all participants at the beginning of baseline recording and at the end of treatment (six months).
Secondary outcome measures
Questionnaire measures will be administered to all participants at the beginning of baseline recording and at the end of treatment (six months):
1. Liverpool Adverse Events Profile
2. Spanish Center for Epidemiologic Studies, Depression Scale
3. Drug related problems
Overall trial start date
03/05/2010
Overall trial end date
28/02/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Female, over 18 years
2. Diagnosis of epilepsy for more than a year
3. In treatment with antiepileptic drugs
4. Having at least one crisis in the last year
5. Ability to comply with the directions of the study
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
182 patients
Participant exclusion criteria
1. Active major psychiatric disorder
2. Physical deficit (e.g., hemiplegia) or mental (e.g., mental retardation), preventing them from answering questionnaires
3. Drug/alcohol dependence
4. Involvement, earlier in the pharmaceutical care program of the institution
Recruitment start date
03/05/2010
Recruitment end date
28/02/2011
Locations
Countries of recruitment
Colombia
Trial participating centre
Crr 30 45-03 Edificio 450
Bogotá
001
Colombia
Sponsor information
Organisation
Universidad Nacional de Colombia (Colombia)
Sponsor details
Dirección de Investigación Sede Bogotá
Cra. 45 26-85 (Edificio "Uriel Gutiérrez") Of. 206 y 219
Bogotá
001
Colombia
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Universidad Nacional de Colombia (Colombia) - Research Division of Bogotá (DIB) (ref: 202010011419 Quipu Code)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25358723
Publication citations
-
Results
Losada-Camacho M, Guerrero-Pabon MF, Garcia-Delgado P, Martínez-Martinez F, Impact of a pharmaceutical care programme on health-related quality of life among women with epilepsy: a randomised controlled trial (IPHIWWE study)., Health Qual Life Outcomes, 2014, 12, 1, 162, doi: 10.1186/s12955-014-0162-8.