Effect of Patient Education on Compliance and Cardiovascular Risk Parameters (FAILAKA)
Effect of Patient Awareness and Education on Compliance and Cardiovascular Risk Factor Control
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Prospective cluster randomized interventional study with primary health care clinics as clusters.Clinics will be randomized to conventional care or to structured patient education in addition to care. Trained physicians will extract information from the patient medical record and will conduct a personal interview with the participants, after they finish with their routine visit, to fill a case report form (CRF)
CRF will include the following items:
- Patient Demographics,
- Socioeconomic: income, employment and education
- Past Medical History
- Smoking history
- Alcohol use
- Medications
- Adherence: Morisky scale
- Examination: BP, weight, height, waist
- Investigations: LDL-C, HbA1C 2.Compliance/adherence to the medication will be measured by using the Morisky scale, which is a validated scale for measuring adherence in hypertension and diabetic patients among other disease.
Patients attending clinics that are randomized to structured patient education will receive education targeting all the risk factors they have. They will be informed about specific evidence -based target values they should achieve for each of the risk factors. Their compliance to prescribed medications will be encouraged and specific advice about improving compliance will be given. To achieve this physicians in the education clinics are going to use two items:
- Framingham Risk Score calculator.
- Know your numbers patient booklet.
Follow up visits will be scheduled at 2 months, 6 months and 12 months after the initial visit. For patients in both education and conventional clinics, compliance to medications will be assessed and the degree of risk factor control will also be determined through specific measurements that include number of cigarettes smoked, systolic and diastolic blood pressure, body mass index and waist circumference, HBA1C and LDL values.
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Patients with one or more CVD risk factors will be consecutively enrolled, smokers and obese patients should have an additional risk factors
- The risk factors are based on Framingham Risk Score calculator and include smoking, high blood pressure, high blood cholesterol ,diabetes and being overweight or obese
- All participants must be adults (30 -70 years of age) who give an informed consent
- All participants should be of Kuwaity nationality, literate and fluent in either Arabic or English
- Patients are likely to be available for a one year follow up
Exclusion Criteria:
- Patients with mental disability or severe psychiatric disorder who are unable to provide informed consent or participate in educational activities.
- Patients with severe visual or hearing disability that will prevent participation in the educational activity
- Patients <30 years or >70 years of age
- Illiterate patients
- Non Kuwaity nationals
- Patients who are not permanently resident in Kuwait
- Patient who refuse to provide the informed consent
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Outro: Patient Education
|
Patient Education using the following two instruments:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
cardiovascualr risk factor control
Prazo: 12 months
|
Cardiovascular risk factors control as assessed by the following parameters: HbA1C, Blood pressure, LDL-C, BMI and smoking cessation
|
12 months
|
|
medication compliance
Prazo: 12 months
|
Medication compliance as assessed by Morisky scale
|
12 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Samia Almusallam, FRCGP, Kuwait Institute for Medical Specialization
- Investigador principal: Maleka M Serour, MRCGP/ INT, Kuwait Institute for Medical Specialization
- Investigador principal: Wafa A Rashed, FRCP, Ministry of Health -Mubarak Hospital- Cardiology unit
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- WS964765
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