Impact of pharmaceutical intervention in women with epilepsy
| ISRCTN | ISRCTN46864306 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46864306 |
| Secondary identifying numbers | 01-2010 |
- Submission date
- 27/04/2010
- Registration date
- 07/06/2010
- Last edited
- 21/02/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Martha Losada-Camacho
Scientific
Scientific
Crr 30 45-03 Edificio 450
Farmacia Oficina 215
Ciudad Universitaria
Bogotá
001
Colombia
| Phone | +57 (0)1 3114445288 |
|---|---|
| mlosadac@unal.edu.co |
Study information
| Study design | Randomised controlled pragmatic trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Impact of pharmaceutical intervention in the treatment and quality of life of women with epilepsy: a randomised controlled pragmatic clinical trial |
| Study acronym | IPHIWWE |
| Study objectives | Will the intervention of the pharmacist in the therapy of women with epilepsy to optimise treatment and improve their quality of life? |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 03/05/2010 |
| Completion date | 28/02/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 182 patients |
| Total final enrolment | 182 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 03/05/2010 |
| Date of final enrolment | 28/02/2011 |
Locations
Countries of recruitment
- Colombia
Study participating centre
Crr 30 45-03 Edificio 450
Bogotá
001
Colombia
001
Colombia
Sponsor information
Universidad Nacional de Colombia (Colombia)
University/education
University/education
Dirección de Investigación Sede Bogotá
Cra. 45 26-85 (Edificio "Uriel Gutiérrez") Of. 206 y 219
Bogotá
001
Colombia
| Website | http://www.unal.edu.co/ |
|---|---|
"ROR" |
https://ror.org/059yx9a68 |
Funders
Funder type
University/education
Universidad Nacional de Colombia (Colombia) - Research Division of Bogotá (DIB) (ref: 202010011419 Quipu Code)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 31/10/2014 | Yes | No | |
| Results article | 15/02/2022 | 21/02/2022 | Yes | No |
Editorial Notes
21/02/2022: Publication reference and total final enrolment added.
