- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02186067
Developing an Integrated System Approach for the Management of Hypertension: A Pilot Study
Hypertension has become a public health concern worldwide due to its significant contribution to the global health burden and its role as a prominent risk factor for the development of a number of chronic diseases such as Cardiovascular diseases (CVD), the leading cause of mortality in Pakistan and Worldwide. According to WHO, about 7.5 million deaths worldwide is attributable to hypertension i.e. about 12.8% of the total of all deaths. This accounts for 57 million disability adjusted life years (DALYS) or 3.7% of total DALYS.
Studies suggest that hypertension is among the top five most common presenting complaints to private general practice clinics. Therefore, primary care physicians/Family physicians are the first line service providers and; thus it is important to manage hypertensive patients early, through lifestyle and treatment interventions that may prevent the complications such as development of CVDs etc.
Visão geral do estudo
Descrição detalhada
To the best of authors' knowledge limited evidence is available from Pakistan on management of hypertension through an integrated approach. Therefore, the aim of the trial is to develop a health delivery system that effectively manages hypertension at primary care level.
Hypothesis: The development of an integrated management approach will be effective in managing hypertension at all levels among hypertensive patients.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
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Sindh
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Karachi, Sindh, Paquistão
- The Integrated Medical Services Clinics (IMS)
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Individuals aged 40 years or over visiting the selected IMS centre with known hypertension or with consistently elevated BP on two separate visits (mean of last two of three measurements of systolic pressure ≥140 mm Hg or mean diastolic pressure ≥90 mm Hg) or already receiving treatment will be eligible for inclusion in the study.
Exclusion Criteria:
- Those patients who require intensive care unit or coronary care unit admissions, or are diagnosed to have cognitive impairment, are agitated due to severe pain, non-resident of Karachi, or having language barrier will be excluded from the study.
- A screening form will be designed for the collection of the above mentioned information. The rationale of excluding all the participants with above mentioned condition is that the participants having these health concerns will either not be able to respond to our questionnaire or their presence may confound our results.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Referral System
Referral System: Primary Level Secondary Level Tertiary Level |
Primary Level: Refer patients to secondary care centre if Patients has complicated hypertension (Patients with target organ damage, CVD, CKD or more the 3 drugs) Secondary Level: Community health center at Aga Khan University will serve as the secondary care center. Family physician will manage patients with CVD, CKD or more than 3 drugs. Tertiary care: Cardiologist at the Aga Khan University will manage secondary, resistant and difficult to treat hypertension. Behavioral: Other Interventions CME session by Cardiologist/Consultant Family Physician : At start , and at two months Community screening by Family physicians at the primary care center (open house) once in three months Patient group education session. Once in three months |
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Sem intervenção: Control
Usual/routine care will be provided to the patients
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
At least an absolute 20% point greater proportion of participants in the intervention group achieving blood pressure targets ( SBP <140 mmHg and DBP < 90mmHg)
Prazo: 6 months
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6 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Adherence to life style modification
Prazo: 6 months
|
Adherence to life style modification (exercise, diet, medication) by the patients: This will be assessed through self-report, anthropometric and blood pressure measurement and empty blister count at the follow up visits.
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6 months
|
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Adherence by physicians to hypertension management guidelines
Prazo: 6 months
|
Adherence by physicians to hypertension management guidelines: assessed through monthly audits conducted by the research medical officer.
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6 months
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Cost-Effectiveness
Prazo: 6 months
|
Cost-Effectiveness: cost of medication (self-report by patient), cost of physician visit (clinic data) etc.
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6 months
|
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Patient Satisfaction
Prazo: 6 months
|
Patient Satisfaction: This would be assessed through PSQ-18.
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6 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Waris Qidwai, Aga Khan University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 13102013FM
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