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Management of Hypertension and Multiple Risk Factors to Enhance Cardiovascular Health

2014年12月31日 更新者: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.

調査の概要

詳細な説明

  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.

研究の種類

介入

入学 (実際)

100

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • Singapore、シンガポール、389707
        • SingHealth Polyclinics, Geylang
      • Singapore、シンガポール、529203
        • SingHealth Polyclinics, Tampines

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

40年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:ヘルスサービス研究
  • 割り当て:非ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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
介入なし:Usual Care
Control group

この研究は何を測定していますか?

主要な結果の測定

結果測定
時間枠
Change in Systolic Blood Pressure from baseline to final follow-up at 3 months
時間枠:Baseline, month 3
Baseline, month 3

二次結果の測定

結果測定
メジャーの説明
時間枠
Proportion of planned orientation sessions delivered
時間枠: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
時間枠:3 months
3 months
Percent of data (laboratory and medication) retrieved from the polyclinic electronic database
時間枠: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
時間枠: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
時間枠:Baseline
Baseline

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Tazeen H Jafar, MD, MPH、Duke-NUS Graduate Medical School
  • 主任研究者:Ngiap Chuan Tan, MBBS、SingHealth Polyclinics, Research

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2014年7月1日

一次修了 (実際)

2014年12月1日

研究の完了 (実際)

2014年12月1日

試験登録日

最初に提出

2014年12月28日

QC基準を満たした最初の提出物

2014年12月31日

最初の投稿 (見積もり)

2015年1月1日

学習記録の更新

投稿された最後の更新 (見積もり)

2015年1月1日

QC基準を満たした最後の更新が送信されました

2014年12月31日

最終確認日

2014年12月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 2013/663/E

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