Management of Hypertension and Multiple Risk Factors to Enhance Cardiovascular Health
Management of Hypertension and Multiple Risk Factors to Enhance Cardiovascular Health - A Cluster Randomized Pilot Trial in SingHealth Polyclinics, Singapore
調査の概要
詳細な説明
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.
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.
- Study Design: It is a non-randomized community intervention trial designed to test feasibility of structured multi-component intervention in polyclinic setting.
- Setting: The study involves two polyclinics in Singapore. One delivers intervention and one delivers usual care.
- 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.
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
- 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.
- 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.
- 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).
- Usual Care: The health providers in the polyclinic with usual care will continue their existing practices.
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.
- 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
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Singapore、シンガポール、389707
- SingHealth Polyclinics, Geylang
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Singapore、シンガポール、529203
- SingHealth Polyclinics, Tampines
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
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
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
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The multifaceted intervention consists of three main components:
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介入なし:Usual Care
Control group
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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
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Baseline, month 3
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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
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Percent uptake of motivational interviewing sessions
時間枠:3 months
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3 months
|
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Percent of data (laboratory and medication) retrieved from the polyclinic electronic database
時間枠:At month 3
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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.
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At month 3
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Proportion of blood pressure readings obtained at final follow-up
時間枠:At month 3
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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%.
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At month 3
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Proportion of participants recruited
時間枠:Baseline
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Baseline
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協力者と研究者
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
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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