From left: Sofia Kasradze, Natela Okujava, Hanneke de Boer, Ley Sander and Tarun Dua.
Click here to read a progress Report of the Georgia Demonstration Project
During Phase II of the Campaign Demonstration Projects were set up in the AFRO, AMRO, SEARO and WPRO Regions, but no such activity had been initiated in European Region. After ample discussions with the Regional Advisor for Mental Health it was decided to select Georgia as the first country to develop a Demonstration Project in the European Region as the country fulfilled all formal selection criteria for such a project.
Georgia is one of the republics of the former Soviet Union and is situated in the Caucasus region of Eurasia, at the juncture of Eastern Europe and Western Asia; it is bounded to the west by the Black Sea; to the north by Russia; to the south by Turkey and Armenia; and to the east by Azerbaijan. Georgia covers a territory of 69,700 km² and its population is 4.3 million. The population consists of 12 ethnical groups of whom 52% are urban and 48% rural. The gross annual income per capita is US$250.00.
After the announcement of independence in the early nineties, due to periodic external aggression and separatism in the country, one third of the territory of Georgia went out of the area of its jurisdiction. Since then up to half a million refugees have been living in very poor social and economic conditions in various parts of the country. Economic, social and health care systems have been totally destroyed. The economy in Georgia collapsed and the country received developed country status.
Health care reforms started and in most cases were unsuccessful. In 1997 the only epilepsy centre was abolished and in 2001 the entire Institute of Neurology was destroyed. Epilepsy completely disappeared from the health care system. Visits to doctors and investigations became chargeable and costly, for AEDs the patients had to pay out of pocket. Cases of self-treatment, use of herbal medicines, admittance to fortune-tellers, mullahs etc., dramatically rose. As a result, inadequate treatment, treatment gaps, status epilepticus and epilepsy mortality cases increased.
Since 2004 democratic activities in Georgia have gone through a positive evolution, but many difficulties in the flow of this process still remain. Presently there is a huge gap between a few clinical units focusing on epilepsy and the rest of the health care system in Georgia, where the level of knowledge on epilepsy is extremely low.
The main problems facing epilepsy care are:
- Poor state financing of the health care system (US$75,000 per annum);
- Absence of medical insurance;
- Absence of a registration system of morbidity and ambulatory supervision;
- Absence of a coordinating system of drug supply, high prices on medicines and their unavailability for most of the population;
- Absence of standards of disease management;
- Lack of educational and special literature, lack of treatment and diagnostic guidelines;
- Very low educational level of primary health care physicians and nurses, as well as epilepsy specialized neurologists;
- Lack of epilepsy information for patients, high stigmatization level;
- Absence of neuropsychological services and psychosocial rehabilitation;
- Low quality of life of people with epilepsy;
The project aims at testing the feasibility of diagnosing and treating convulsive forms of epilepsy at primary care level, using phenobarbital, carbamazepine or sodium valproate as the first option. The long-term objective is to integrate epilepsy management into the existing primary health delivery system in rural and semi-rural areas of Georgia in a sustainable manner.
- Improvement of epilepsy patients identification, treatment and problem management in the provinces of Georgia at primary health care level with active participation of society;
- Elaboration of an epilepsy management model at primary health care level, which might be implemented universally;
- To estimate the prevalence of active forms of convulsive epilepsy, the scale of the treatment gap via an active case finding methodology, and changes the project may bring to these figures in the study area.
- To assess the impact on their practice of training for epilepsy of health practitioners at the primary health level.
- To develop national guidelines (manual) for the identification, education, treatment and follow-up of patients with epilepsy at a primary health care level.
- To carry out a feasibility study of the treatment of convulsive forms of epilepsy using carbamazepine, valproate and/or phenobarbital by primary health care doctors.
- To develop a programme for continuous professional education on epilepsy for primary health care professionals.
- To promote public awareness of epilepsy by way of an educational programme aimed at the community.
- To develop local advocacy and support groups for people with epilepsy.
- To reduce the economic and social burden of epilepsy in the study areas.
The Project consists of three parts:
- Epidemiological evaluation facilitates to establish the real picture of untreated patients;
- Provision of medical services to people with epilepsy (intervention study): correct diagnostics elaboration of monitoring schedules for the patients on PB, CBZ and VPA treatment;
- Public education and social intervention: education of various target groups on social aspects of epilepsy.
- Epidemiological evaluation:
The epidemiological exercise aimed at estimating the prevalence of active epilepsy and the treatment gap.
Patients screening was performed in selected areas by means of special surveyors and door-to-door assessment. A screening Questionnaire based on the one used previously in China was utilized.
The Questionnaire was adapted and subjected to Georgian-English onward-backward translation before the final version was validated. This was carried out at the Epilepsy Prevention and Control Centre (CPCE) and showed sensitivity 98.8% and specificity 87.0%.
The prevalence of epilepsy was found to be 0.8%. The treatment gap (people not being diagnosed and treated appropriately) came to 66.6% (out of 88 people with epilepsy 14 were newly diagnosed and received no treatment before, 8 were not treated at all and 36 were treated inappropriately). The data will be revisited in order to determine the lifetime prevalence.
The survey will be repeated using a similar methodology and instruments at the end of a four-year period to ascertain if there has been a measurable change in the treatment gap in the areas surveyed.
- Provision of medical services to people with epilepsy (intervention study)
The target population are patients with untreated convulsive epilepsy who fulfil the entry criteria and live in one of the s study areas. A variety of case-finding methods was used. Identification of patients is primarily carried out by senior primary health care physicians. Each neurologist of a family medicine centre or policlinic usually knows each residents health condition and family situation and this help with the identification of patients. Patients will be encouraged to self-report.
The doctor/neurologist completes a diagnostic questionnaire for those patients preliminary identified as possible cases of convulsive epilepsy. Senior primary health care physicians will then confirm the diagnosis. All primary health care physicians in the study area receive training in epilepsy and a continuous educational programme in epilepsy has been initiated. The neurologists will be responsible for checking the selected patients.
For the patients included in the study, a special inclusion form will be completed by the local investigator where patients demographic data, retrospective assessment of convulsive seizures, and employment status will be noted. If the patient is an employee or is a student, some additional information from these institutions will be obtained. After performing these procedures, PB, CBZ or VPA will be prescribed according to the agreed norms and schedules.
Primary health care physicians will explain the necessity of taking AEDs regularly, of strictly following the prescribing regime etc.; inform the patient about side effects of AEDs and advise of the importance of contacting the doctor as soon as these appear. The patients will receive contact information about the primary health care physician and the schedule of visits to the doctors surgery. Patients included in the study will be invited to attend the medical Centres of the selected districts of Tbilisi every two weeks for the first two months and monthly thereafter. The doctor will assess frequency of epileptic seizures, side effects and treatment efficacy. In case of any doubts, or if the side-effects are severe or persistent, the patient should be referred to the local neurologist.
Preliminary data about the number of patients with epilepsy involved in this study will be available later.
If a patient withdraws from the study, a termination form will be filled recording the reasons for the drop out. The patient will receive alternative or further treatment or will be referred to another level of care, according to clinical needs.
If the patient is excluded from the study, a special form for exclusion will be filled. The reason for exclusion should be defined. In such cases the patient will be sent to an appropriate institution for further treatment.
- Educational and social intervention
These activities are aimed at the following target groups:
- Local health care primary level personnel – nurses, also volunteers, paramedics etc;
- Local health care secondary level personnel (neurologists, psychiatrists);
- Patients and their families;
- Personnel of primary and secondary schools;
- Local authorities (government, police);
All local investigators and primary health care doctors receive training in epilepsy. The training is performed by the Center of Epilepsy Management, Investigation and Education at Tbilisi State Medical University and Epilepsy Control and Prevention Center working groups.
The following issues on epilepsy are covered:
- Primary health care aspects of epilepsy;
- The causes of epilepsy;
- Differential diagnosis of epilepsy;
- Diagnostics of convulsive forms of epilepsy;
- Adequate AED treatment of epilepsy;
- Epilepsy management;
- Current project purpose and how to fill in special forms;
During training each doctor will be provided with a working plan and educational literature.
Prior to training all doctors complete a questionnaire for assessment of their awareness on epilepsy, attitudes towards epilepsy and epilepsy management experience (KAP). These questionnaires are completed before study starts and also 3 and 6 months after the study. The Georgian version of the KAP questionnaire is being used.
Public education on epilepsy is aimed at a number of target groups including various members of society – school teachers, employees, police, also professional groups – journalists, clergymen etc.
The purpose of educational activities for patients and their families is to inform them about:
- Epilepsy disorder, causes and prognosis;
- Epilepsy treatment, importance of compliance, side effects;
- First aid during epilepsy seizure;
The educational programme has been developed by the working groups. Information leaflets have been dispensed among patients and their caregivers. Local physicians and neurologists hold regular lectures for patients and their caregivers.
Social and public intervention aims at reducing epilepsy stigma in society. The target audience for this activity consists of teachers of primary and secondary schools as they have much influence on public attitudes. Their help is very important in identifying epilepsy in the early stages. The educational programme focuses on information to the public, on superstitions and misunderstandings concerning epilepsy, which are the important sources of discomfort and low self-esteem in people with epilepsy.
Additional activities include:
- Information on epilepsy via public communication facilities;
- Distribution of information on epilepsy to the public;
- Elaboration and distribution of posters;
- Setting up support groups consisting of local health care authorities, patients/caregivers and volunteers.
Organisational Context and Management Structure
This demonstration project is carried out under the auspices of the Global Campaign Against Epilepsy. The work is executed by two teams and two principal investigators: a team from the Centre for Epilepsy Management, Research and Education, Tbilisi State Medical University headed by Dr Natela Okujava and a team from the Centre of Epilepsy Control and Prevention headed by Dr Otar Toidze. An Advisory Board was proposed by doctors Natela Okujava and Otar Toidze and appointed accordingly by the Campaign Secretariat. It was proposed initially that Leonid L Prilipko and Hanneke M de Boer would act as supervisors/monitors of the Project on behalf of the Global Campaign’s Secretariat, whilst Dr Ley Sander would be the Scientific Project Leader. The Global Campaign Co chairs 2005-2009, Giuliano Avanzini and Philip Lee, together with Leonid Prilipko on behalf of WHO would be responsible for the Demonstration Project, which is supported by the Ministry of Labour, Health and Social Affairs of Georgia. Following his untimely death, Leonid Prilipkos role was taken over by Tarun Dua of the WHO.
Click here to read a progress Report of the Georgia Demonstration Project