Condition category
Nervous System Diseases
Date applied
27/04/2010
Date assigned
07/06/2010
Last edited
03/11/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.unal.edu.co/

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25358723

Publication citations

  1. 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.

Additional files

Editorial Notes