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治験 NCT01142908（対象：心血管疾患、高血圧、糖尿病、高脂血症）は完了です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
Cardiovascular Intervention Improvement Telemedicine Study 428 退役軍人 食事療法 新規治療
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT01142908 は 介入研究 臨床試験 で、心血管疾患、高血圧、糖尿病、高脂血症 を対象とした研究でした。現在は 完了 です。2011年11月1日 に開始し、428 名の参加者 が参加しました。この試験は VA Office of Research and Development によって主導され、2015年5月22日 に完了しました。ClinicalTrials.gov からの最新更新日は 2023年7月27日 です。
概要
Cardiovascular disease (CVD) is the leading cause of death in the United States; more than 80% of veterans have > 2 risk factors for CVD. Our study is one of the first to examine the implementation of a tailored behavioral/educational self-management intervention in primary care clinics designed to improve CVD risk. The proposed study could result in a leap forward in CVD risk management among veterans for several r...もっと見る
詳細説明
Anticipated Impacts on Veteran's Healthcare: Cardiovascular disease (CVD) is the leading cause of death in the U.S.; more than 80% of veterans have > 2 risk factors for CVD. An intervention that addresses multiple CVD risk factors among high-risk veterans has the greatest potential to improve morbidity and mortality.
Project Background/Rationale: The proposed study will take place in two VA primary care clinics (1-...
もっと見る公式タイトル
Cardiovascular Intervention Improvement Telemedicine Study
疾患名
心血管疾患高血圧糖尿病高脂血症刊行物
この臨床試験について発表された科学記事と研究論文：その他の研究識別子
- IIR 08-297
- 08-297 (その他の助成金/資金番号) (VA HSRD)
NCT番号
開始日
2011-11-01
最終更新日
2023-07-27
終了予定日
2015-05-22
目標参加者数
428
試験の種類
介入研究
治験の相・段階
該当なし
状況
完了
キーワード
Cardiovascular Disease
Hypertension
Diabetes
Hyperlipidemia
Adherence
Hypertension
Diabetes
Hyperlipidemia
Adherence
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Arm 1 The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months. | Pharmacist CVD clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months. |
非介入Arm 2 The education control group - these participants will receive educational material about CVD reduction. | 該当なし |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent) | Components of the Framingham include gender, age fixed at baseline, systolic blood pressure (presence/absence of blood pressure medications at each time point \[combination of administrative med data pull and self-report at assessment\]), total cholesterol, HDL cholesterol, smoking status (assessed via self-report at each study survey), and diabetes (diabetes is a combination of self-report and VA Computerized Patient Record System (CPRS) data review). "New cases" of diabetes are allowed to be updated at 6 and 12 months f/u. | Baseline |
Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent) | Components of the Framingham include gender, age fixed at baseline, systolic blood pressure (presence/absence of blood pressure medications at each time point \[combination of administrative med data pull and self-report at assessment\]), total cholesterol, HDL cholesterol, smoking status (assessed via self-report at each study survey), and diabetes (diabetes is a combination of self-report and CPRS data review). "New cases" of diabetes are allowed to be updated at 6 and 12 months f/u. | 6 months |
Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent) | Components of the Framingham include gender, age fixed at baseline, systolic blood pressure (presence/absence of blood pressure medications at each time point \[combination of administrative med data pull and self-report at assessment\]), total cholesterol, HDL cholesterol, smoking status (assessed via self-report at each study survey), and diabetes (diabetes is a combination of self-report and CPRS data review). "New cases" of diabetes are allowed to be updated at 6 and 12 months f/u. | 12 months |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Mean Systolic Blood Pressure | Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews | Baseline |
Mean Systolic Blood Pressure | Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews | 6 months |
Mean Systolic Blood Pressure | Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews | 12 months |
Mean Diastolic Blood Pressure | Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews | Baseline |
Mean Diastolic Blood Pressure | Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews | 6 months |
Mean Diastolic Blood Pressure | Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews | 12 months |
Medication Non-adherence | First 4 items of the 5 item Morisky Self-reported measure of medication adherence was used to determine medication non-adherence. | Baseline |
Medication Non-adherence | First 4 items of the 5 item Morisky Self-reported measure of medication adherence was used to determine medication non-adherence. | 6 months |
Medication Non-adherence | First 4 items of the 5 item Morisky Self-reported measure of medication adherence was used to determine medication non-adherence. | 12 months |
Cholesterol LDL | Collected during interview visit by lab personnel | Baseline |
Cholesterol LDL | Collected during interview visit by lab personnel | 6 months |
Cholesterol LDL | Collected during interview visit by lab personnel | 12 months |
Body Mass Index | Calculated from vitals (height \& weight) obtained during interview | Baseline |
Body Mass Index | Calculated from vitals (height \& weight) obtained during interview | 6 months |
Body Mass Index | Calculated from vitals (height \& weight) obtained during interview | 12 months |
HBA1C in Diabetic Patients | Lab values collected at interview visit by lab personnel | Baseline |
HBA1C in Diabetic Patients | Lab values collected at interview visit by lab personnel | 6 months |
HBA1C in Diabetic Patients | Lab values collected at interview visit by lab personnel | 12 months |
適格基準
対象年齢
小児, 成人, 高齢者
対象性別
全て
- Enrolled in one of three Durham Veterans Affairs Medical Center (DVAMC) Primary Care Clinics affiliated with the hospital or the Raleigh Community-Based Outpatient Clinic (CBOC) for at least one year;
- At least one visit to a primary care physician (PCP) at the Raleigh CBOC or Durham Veterans Affairs Medical Center (VAMC) associated primary care clinics in the previous 12 months;
- Outpatient diagnostic code for hypertension and/or hypercholesterolemia and lab values indicating either poorly controlled BP levels (>150/90 Hg) AND/OR LDL (>130mg/dl) in the previous year.
- diagnosed with metastatic cancer,
- diagnosed with dementia,
- active diagnosis of psychosis,
- treated with dialysis,
- most recent creatinine lab level >2.5 or no creatinine lab value within past year
- hospitalized for a stroke, heart attack, or had surgery for blocked arteries in the past 3 months,
- participating in another interventional trial,
- not currently receiving care at the Durham VAMC or the Raleigh CBOC
- resident of a nursing home,
- hard time seeing type/printing on books, magazines articles, etc.
- hard time hearing on the telephone
- limited/no access to telephone
- plans to move medical care from DVAMC or Raleigh CBOC in next 12 months
- CVD care is currently being managed by a clinical pharmacist
- HbA1C value in the last 90day > 10% and patient is currently not on an insulin regimen.
VA Office of Research and Development連絡先情報がありません。
1 1カ国の場所
North Carolina
Durham VA Medical Center, Durham, NC, Durham, North Carolina, 27705-3875, United States