A Home-based Blood Pressure Monitoring Program to Promote Better Management of Hypertension
A Home-based Blood Pressure Measurement Program in Hypertensive Patients to Promote Medications Adherence and Blood Pressure Status.
調査の概要
詳細な説明
Adherence to treatment is disappointingly low among patients with chronic health disorders especially after 6 month of initiating drug therapy. In hypertensive patients , as reported by WHO, 50% of non-adherence could be expected. Poor adherence to anti hypertensive medications results in increased morbidity, mortality and costs. One of the reasons that could implicate medications adherence can be attributed to seeing no physical sign of better controlling blood pressure. Self monitoring of blood pressure at home has been reported to improve patients adherence to their medications.
This study is a 2-arm randomized controlled trial. The investigators aim to evaluate the effect of home-based blood pressure measurement with an electronic device on medication adherence and blood pressure status.
One hundred ninety six hypertensive patients aged at least 18 years old are recruited in an ambulatory care setting and are evenly allocated to the study arms with balanced-block telephone randomization.
Appropriate medication is prescribed as preferred by the cardiologist (single daily dose medicines are recommended). Patients in both arms are followed for 24 weeks, each will be visited by the cardiologist four times during the study period. In each visit, patients' blood pressure will be measured twice by a nurse in the office.
In the intervention arm, electronic blood pressure device is provided for each patient and he/she will be trained to measure blood pressure at home once daily (same time each day). A logbook is also provided to document the daily blood pressure level.
Primary outcome of the study is the blood pressure measured at each office visit overtime. Medication adherence is measured by pill count method as the secondary outcome.
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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Tehran、イラン・イスラム共和国
- Dr Mohagheghi's Office
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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:
- Ambulatory patients older than 18
- Patients newly diagnosed as hypertension stage 1
- Patients previously on antihypertensive treatment but uncontrolled hypertension
- Patients not possessing electronic self blood pressure measurement device
- Patients with functional ability to use the device
Exclusion Criteria:
- Patients requiring two or more antihypertensive drugs at the start of the study
- Patients with secondary hypertension
- Patients cardiovascular comorbidities and other interfering medical conditions
- Patients with drug contraindication or documented drug allergy
- Patients with serum creatinine > 150 microliters
Withdrawal criteria:
- Inadequate therapeutic effect requiring an increase of more than 20% in pre-established number of visits
- Emergence of adverse drug reactions requiring cessation of medication
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Home-based blood pressure monitoring
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Electronic blood pressure device is provided for patients and he/she will be trained to measure blood pressure at home once daily(same time each day).
A logbook is also provided to document the daily blood pressure level.
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アクティブコンパレータ：普段のお手入れ
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Four visits to the physician's office at 4th, 12th, 24th week in the study period with usual advice giving practice of the staff.
At the end of the trial period, an electronic blood pressure device will be given to each patient in this arm.
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Blood pressure-24 weeks
時間枠：Change from baseline(at the point of recruiting) blood pressure at 24 weeks.
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Blood pressure is measured twice by trained nurses using hand-cuff device at the physician office.
(in Hg millimeter)
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Change from baseline(at the point of recruiting) blood pressure at 24 weeks.
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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 |
|---|---|---|
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Medication adherence-4 weeks
時間枠：Change from baseline(at the point of recruiting) medication adherence at 4 weeks
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Change from baseline(at the point of recruiting) medication adherence at 4 weeks
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Blood pressure- 4 weeks
時間枠：Change from baseline(at the point of recruiting) blood pressure at 4 weeks.
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Change from baseline(at the point of recruiting) blood pressure at 4 weeks.
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Blood pressure- 12 weeks
時間枠：Change from baseline(at the point of recruiting) blood pressure at 12 weeks.
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Change from baseline(at the point of recruiting) blood pressure at 12 weeks.
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Medication adherence- 12 weeks
時間枠：Change from baseline(at the point of recruiting) medication adherence at 12 weeks
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Change from baseline(at the point of recruiting) medication adherence at 12 weeks
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Medication adherence-24 weeks
時間枠：Change from baseline(at the point of recruiting) medication adherence at 24 weeks
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Pill count method is employed.
At the time of each office visit, patients bring their medications with themselves and the researcher counts the unused pills.
Adherence is calculated as percentage of the pills used during previous weeks.
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Change from baseline(at the point of recruiting) medication adherence at 24 weeks
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協力者と研究者
捜査官
- スタディチェア：Kheirollah Gholami, M.Sc,PharmD、Tehran University of Medical Sciences
- スタディディレクター：Zahra Jahangard-Rafsanjani, PharmD、Tehran University of Medical Sciences
- 主任研究者：Arash Rashidian, M.D, Ph.D、Tehran University of Medical Sciences
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
本研究に関する用語
その他の研究ID番号
- 90-04-156-15281
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