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Management of Hypertension and Multiple Risk Factors to Enhance Cardiovascular Health

31 de dezembro de 2014 atualizado por: Professor Tazeen Jafar, Duke-NUS Graduate Medical School

Management of Hypertension and Multiple Risk Factors to Enhance Cardiovascular Health - A Cluster Randomized Pilot Trial in SingHealth Polyclinics, Singapore

High blood pressure (BP) is a serious public health problem responsible for heart attack, stroke and kidney failure. One in four adults in Singapore has hypertension. We propose a pilot study in 2 polyclinics in Singapore, 1 deliver a structured multi-component intervention and another usual care. A total of 100 adults with uncontrolled high blood pressure will be followed for 3 months. The intervention includes 1) algorithm-driven antihypertensive treatment for all patients using fixed-dose combination and lipid lowering for high risk patients, 2) motivational conversation for high risk patients; and 3) telephone based follow-ups of all patients by a team of physician supervised nurse practitioners and nurses. The change in BP will be compared between intervention and control groups. The structured care including the above mentioned components is likely to be more effective than usual care in lowering BP levels of patients with uncontrolled high blood pressure. Such a program is also likely to be more cost effective in terms of money spent for improving quality of patients' life. The findings of the pilot will inform the design of a larger cluster randomized trial in eight polyclinics in Singapore. If the main study is successful, the findings will be informative for policymakers to roll out intervention in all polyclinics and primary care centers across Singapore, and other countries with similar healthcare infrastructure.

Visão geral do estudo

Status

Concluído

Descrição detalhada

  1. Background:

    Cardiovascular diseases (CVD) are the leading cause of disability and death in Singapore, and consume substantial healthcare resources. Uncontrolled hypertension confers the highest attributable risk of CVD. About one in four adults suffer from hypertension in Singapore, 50% of them have uncontrolled blood pressure (BP), and management is especially sub-optimal among those with concomitant diabetes or dyslipidemia. Evidence suggests that well structured programs of care delivery are effective in lowering BP and preventing CVD. However, there is lack of empirical data on such strategies in Singapore.

    The findings of the pilot will inform the design of a larger cluster randomized trial in eight polyclinics in Singapore. If proven effective in the main study, the information will be valuable in convincing the policy-makers to upscale strategies for enhancing management of hypertension and cardiovascular health within the primary health infrastructure of Singapore, and possibly neighbouring Southeast Asian countries.

  2. Aims:

    Specific aim 1: To explore logistics for delivery of provider training in intervention algorithm and motivational counselling while maintaining optimal efficiency of ongoing clinical work at the polyclinics.

    Specific aim 2: To establish recruitment of participants in the intervention and usual care groups, and uptake of each component of the multicomponent intervention.

    Specific aim 3: To establish mechanism for capture and retrieval of the relevant clinic visit data (physician and nurses records, pharmacy and laboratory including costs) at the polyclinic, and telephone follow-ups, hospitalization and related costs.

    Specific aim 4: To explore impact of intervention vs usual care on change in BP in the short term.

    Specific aim 5: Identify appropriate methods for capturing potential adverse events and safety endpoints related to intervention.

  3. Study Design: It is a non-randomized community intervention trial designed to test feasibility of structured multi-component intervention in polyclinic setting.
  4. Setting: The study involves two polyclinics in Singapore. One delivers intervention and one delivers usual care.
  5. Study population: The polyclinics have a system in place such that all patients with hypertension get a "panel" of fasting blood and urine tests at subsidized cost at the time of initial diagnosis and then annually. The individuals visiting polyclinic for their initial (or annual) panel of laboratory tests marked as "hypertension panel" will be screened for eligibility and recruited if eligible. One hundred patients (50 per polyclinic) will be recruited and followed for 3 months.
  6. Intervention: Orientation training sessions will be organized for all physicians, nurse practitioners (NP) and nurses in the polyclinic assigned the intervention which is comprised of 3 components

    1. Structured treatment algorithm with fixed dose antihypertensives for high risk patients: The training curriculum including treatment algorithm has been prepared by a team of nephrologists, cardiologists and pharmacologists in consultation with primary care physicians and Clinical Cardiovascular Work Group, using the case method, aiming for global cardiovascular risk reduction.
    2. Motivational conversation by NPs and nurses for high risk patients at baseline: Separate training sessions will be conducted for NP and nurses. NP and nurses will receive training on motivational conversation techniques and communication strategies from a trainer skilled in communication in health care. These nurse and nurse practitioners will provide motivational conversation sessions to high CVD risk patients at baseline.
    3. Structured follow-up over telephone and in Clinics: NPs and nurses in intervention polyclinic will be proactive in follow-up of their patients for self-monitoring of BP and providing advice for adherence to treatment every 4 weeks for the duration of the project (3 months). A communication checklist for the follow-up will be incorporated to the existing follow-up system. Information on adverse events will be obtained and action plan will be communicated with patients (discontinue the suspected drug and arrange visit to clinic, as appropriate).
  7. Usual Care: The health providers in the polyclinic with usual care will continue their existing practices.
  8. Outcomes assessment: Final outcome assessment will take place three months after baseline. The outcomes assessors will also call the patients over telephone for outcomes assessment at week 6 after baseline. Information on self-monitoring of BP, recommended life style change, self-care, and medication use (including herbal and traditional Chinese) will be collected.

    The outcome assessors will also extract process outcomes measures from the general practitioner (GP) and nurses' notes. These will include number and duration of contact with the patient (whether in person or by phone), changes in prescribed medication and dose, and reporting of any adverse events from medications.

  9. Sample size calculation: Sample size was calculated using Stata version 12. A sample size of 90 (45 in each group) achieves 80% power to detect 5 mmHg difference in systolic BP change from baseline to end of follow-up in intervention group compared to usual care group, with an estimated standard deviation (SD) of 9.5, significance level of 0.05 using a two-sided two-sample t-test. Assuming that there could be 10% drop out rate, we plan to take the total sample size of 100 subjects. At least 152 eligible subjects (72 in each group) would be necessary to attain at least 66% recruitment rate.

Tipo de estudo

Intervencional

Inscrição (Real)

100

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

      • Singapore, Cingapura, 389707
        • SingHealth Polyclinics, Geylang
      • Singapore, Cingapura, 529203
        • SingHealth Polyclinics, Tampines

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

40 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • 40 years or older
  • Singapore citizen and Permanent Resident
  • Individuals visiting the recruiting polyclinic at least twice during the last 1 year
  • Individuals with with previously diagnosed hypertension and uncontrolled blood pressure (Systolic BP 140 mmHg and above and diastolic BP 90 mmHg)

Exclusion Criteria:

  • Individuals with active systemic illness including fever
  • Individuals with recent hospitalization (i.e. during last 4 months),
  • Individuals with clinically unstable heart failure (i.e. Ejection fraction <20% or complaint of shortness of breath at rest)
  • Individuals with advanced kidney disease (i.e. estimated Chronic kidney disease (CKD) -Epi glomerular filtration rate <40 ml/min/1.73m2 or nephrotic range proteinuria (i.e. 3g/d or more))
  • Individuals with known advanced liver disease (i.e. Child-Pugh Stage C)
  • Individuals with pregnancy
  • Individuals with any other major debilitating disease or
  • Individuals with mental illness that precludes validity of informed consent

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Pesquisa de serviços de saúde
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Hypertension Management Intervention
Multifaceted hypertension management intervention

The multifaceted intervention consists of three main components:

  1. Structured treatment algorithm with fixed dose antihypertensives for high cardiovascular disease risk patients
  2. Motivational conversation by nurses and nurse practitioners for high risk patients at baseline
  3. Telephone based follow-up for all patients by nurses
Sem intervenção: Usual Care
Control group

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
Change in Systolic Blood Pressure from baseline to final follow-up at 3 months
Prazo: Baseline, month 3
Baseline, month 3

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Proportion of planned orientation sessions delivered
Prazo: Baseline
Orientation training session for treatment algorithm and motivational counseling will be organized in multiple lunch-time sessions. The number of orientation sessions planned will be denominator and the number of sessions successfully delivered will be numerator. Target is 100%.
Baseline
Percent uptake of motivational interviewing sessions
Prazo: 3 months
3 months
Percent of data (laboratory and medication) retrieved from the polyclinic electronic database
Prazo: At month 3
The total number of participants received the laboratory tests and prescribed medications will be denominators and the number of participants whose data are successfully retrieved from electronic database will be numerator. Target is 98% of data retrieved.
At month 3
Proportion of blood pressure readings obtained at final follow-up
Prazo: At month 3
Total number of participants enrolled will be denominator. Number of participants whose blood pressure readings are successfully obtained at final visit (3 months from baseline) will be numerator. Target is 80%.
At month 3
Proportion of participants recruited
Prazo: Baseline
Baseline

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Tazeen H Jafar, MD, MPH, Duke-NUS Graduate Medical School
  • Investigador principal: Ngiap Chuan Tan, MBBS, SingHealth Polyclinics, Research

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de julho de 2014

Conclusão Primária (Real)

1 de dezembro de 2014

Conclusão do estudo (Real)

1 de dezembro de 2014

Datas de inscrição no estudo

Enviado pela primeira vez

28 de dezembro de 2014

Enviado pela primeira vez que atendeu aos critérios de CQ

31 de dezembro de 2014

Primeira postagem (Estimativa)

1 de janeiro de 2015

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

1 de janeiro de 2015

Última atualização enviada que atendeu aos critérios de controle de qualidade

31 de dezembro de 2014

Última verificação

1 de dezembro de 2014

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 2013/663/E

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Ensaios clínicos em Doenças cardiovasculares

Ensaios clínicos em Hypertension Management Intervention

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