Effect of Patient Education on Compliance and Cardiovascular Risk Parameters (FAILAKA)
Effect of Patient Awareness and Education on Compliance and Cardiovascular Risk Factor Control
調査の概要
詳細な説明
Prospective cluster randomized interventional study with primary health care clinics as clusters.Clinics will be randomized to conventional care or to structured patient education in addition to care. Trained physicians will extract information from the patient medical record and will conduct a personal interview with the participants, after they finish with their routine visit, to fill a case report form (CRF)
CRF will include the following items:
- Patient Demographics,
- Socioeconomic: income, employment and education
- Past Medical History
- Smoking history
- Alcohol use
- Medications
- Adherence: Morisky scale
- Examination: BP, weight, height, waist
- Investigations: LDL-C, HbA1C 2.Compliance/adherence to the medication will be measured by using the Morisky scale, which is a validated scale for measuring adherence in hypertension and diabetic patients among other disease.
Patients attending clinics that are randomized to structured patient education will receive education targeting all the risk factors they have. They will be informed about specific evidence -based target values they should achieve for each of the risk factors. Their compliance to prescribed medications will be encouraged and specific advice about improving compliance will be given. To achieve this physicians in the education clinics are going to use two items:
- Framingham Risk Score calculator.
- Know your numbers patient booklet.
Follow up visits will be scheduled at 2 months, 6 months and 12 months after the initial visit. For patients in both education and conventional clinics, compliance to medications will be assessed and the degree of risk factor control will also be determined through specific measurements that include number of cigarettes smoked, systolic and diastolic blood pressure, body mass index and waist circumference, HBA1C and LDL values.
研究の種類
入学 (予想される)
段階
- 適用できない
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:
- Patients with one or more CVD risk factors will be consecutively enrolled, smokers and obese patients should have an additional risk factors
- The risk factors are based on Framingham Risk Score calculator and include smoking, high blood pressure, high blood cholesterol ,diabetes and being overweight or obese
- All participants must be adults (30 -70 years of age) who give an informed consent
- All participants should be of Kuwaity nationality, literate and fluent in either Arabic or English
- Patients are likely to be available for a one year follow up
Exclusion Criteria:
- Patients with mental disability or severe psychiatric disorder who are unable to provide informed consent or participate in educational activities.
- Patients with severe visual or hearing disability that will prevent participation in the educational activity
- Patients <30 years or >70 years of age
- Illiterate patients
- Non Kuwaity nationals
- Patients who are not permanently resident in Kuwait
- Patient who refuse to provide the 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：防止
- 割り当て：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 |
|---|---|
|
他の：Patient Education
|
Patient Education using the following two instruments:
|
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 |
|---|---|---|
|
cardiovascualr risk factor control
時間枠：12 months
|
Cardiovascular risk factors control as assessed by the following parameters: HbA1C, Blood pressure, LDL-C, BMI and smoking cessation
|
12 months
|
|
medication compliance
時間枠：12 months
|
Medication compliance as assessed by Morisky scale
|
12 months
|
協力者と研究者
協力者
捜査官
- 主任研究者：Samia Almusallam, FRCGP、Kuwait Institute for Medical Specialization
- 主任研究者：Maleka M Serour, MRCGP/ INT、Kuwait Institute for Medical Specialization
- 主任研究者：Wafa A Rashed, FRCP、Ministry of Health -Mubarak Hospital- Cardiology unit
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Patient Educationの臨床試験
-
Jewish General HospitalUniversity of Manitoba; McGill University Health Centre/Research Institute of the McGill University... と他の協力者募集
-
University of SheffieldUniversity of Liverpool; University of Manchester; University of Melbourne積極的、募集していない
-
Imperial College Healthcare NHS Trust完了