Titrated Disease Management for Patients With Hypertension (TDM)
2018年9月4日 更新者：VA Office of Research and Development
Randomized Trial of Titrated Disease Management for Patients With Hypertension
This randomized clinical trial examines whether programs aimed at matching resources to patient hypertension (i.e.
high blood pressure) control lead to greater reduction in systolic blood pressure (top number of blood pressure reading) than simply having maintenance phone calls in addition to usual care.
Answering this question will provide important evidence concerning the overall goal of sustained long-term implementation of the disease management programs as part of patient aligned care teams in the Veterans Affairs and other healthcare systems.
調査の概要
状態
完了
条件
詳細な説明
Project Objectives: The investigators are conducting a two-arm 18-month randomized clinical trial for patients with pharmaceutically treated hypertension for which systolic BP is not controlled (>/=140 mmHg for non-diabetic or >/=130 mmHg for diabetic patients).
The primary aim will be to compare two treatment arms/strategies in terms of impact on systolic BP control: Arm 1 - An intervention arm using titrated disease management in which patients' hypertension control, assessed at baseline, 6 and 12 months, will be used to decide the resource intensity of strategies: 1) Medium/level 1 resource intensity strategy: a registered nurse will provide monthly tailored behavioral support telephone calls + home BP monitoring; 2) High/level 2 resource intensity strategy: a pharmacist will provide monthly tailored behavioral support telephone calls + home BP monitoring + pharmacist-directed medication management; and 3) Booster (low) resource intensity strategy: a license practice nurse (LPN) will provide bi-monthly, non-tailored behavioral support telephone calls to patients whose systolic BP comes under control.
Arm 2 - A control arm, in which an LPN will provide bi-monthly non-tailored behavioral support telephone calls (same procedures as the booster (low) resource intensity strategy component of the titrated intervention).
研究の種類
介入
入学 (実際)
385
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
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North Carolina
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Durham、North Carolina、アメリカ、27705
- Durham VA Medical Center, Durham, NC
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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
18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:
- Age >= 18 years.
- Assigned primary care provider in one of the clinics of the Durham VA Medical Center (VAMC) (including Community Based Outpatient Clinics for example - Hillandale Clinic and Greenville (CBOC)).
- Had at least 1 primary care visit at the Durham VA or affiliated CBOC in the last year.
- Diagnosis of hypertension requiring medication, as determined by: ICD 401.0, 401.1, or 401.9 for >= 2 outpatient encounters during the prior year and Received a prescription for at least 1 of the following classes of hypertensive medication in the previous year: 1) ACE inhibitors; 2) alpha blockers; 3) angiogenesis II inhibitors; 4) beta blockers; 5) calcium channel blockers; 6) diuretics; 7) antihypertensive combination; and/or 8) antihypertensives, other.
- Out of control systolic blood pressure: Durham VAMC (including CBOCs or other affiliated clinics captured in the Durham VAMC electronic health record) outpatient BP measurements >= 150 mmHg for non-diabetic or >= 140 mmHg for diabetic patients over the last year and last systolic BP measurement >= 140 mmHg for non-diabetic or >= 130 mmHg for diabetic patients. If additional patients need to be approached to be offered the opportunity for further screening, non-diabetic patients with mean outpatient systolic BP of >= 140 mmHg or diabetic patients with mean outpatient systolic BP of >= 130 mmHg over the past year may be approached.
Patients must indicate that they both:
- Have a VA or affiliated clinic provider that they consider to be their main PCP.
- Receive the majority of healthcare at the Durham VA Medical Center (or affiliated clinic - such as Hillandale or Greenville).
Exclusion Criteria:
- Active diagnosis of psychosis.
- Diagnosis of metastatic cancer.
- Type 1 diabetes
- Class IV congestive heart failure (CHF).
- Currently receiving kidney dialysis or if estimated glomerular filtration rate (eGFR) levels are <= 15.
- Chronic obstructive pulmonary disease (COPD) requiring oxygen.
- Resident in nursing home or receiving home healthcare.
- Patient is pregnant or reports planning to become pregnant in the next two years
- At the time of potential enrollment, participating in another ongoing hypertension, diabetes, cholesterol, or cardiovascular disease clinical trial.
- Planning to leave the area prior to the anticipated end of participation.
- Inability or unwillingness to come to the Durham VAMC or affiliated clinic such as Hillandale or Greenville for baseline-, 6-, 12-, and 18-month study visits.
- Does not have reasonable access to a telephone.
- Does not speak English.
- Severely impaired hearing or speech (Patients must be able to respond to phone calls.).
- Severely impaired vision (Patients must be able to read mailed material).
- Refusal or inability to provide informed consent and HIPAA authorization form.
- Arm size > 50 cm
- Unable to obtain (including by arm) valid blood pressure readings
- Inadequate mental status to complete the protocol, as judged by five or more errors on the Short Portable Mental Status Questionnaire (SPMSQ).
- Former, current or pending solid organ or bone marrow transplant patient.
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：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 |
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実験的：Titration Intervention
The intervention arm includes three levels of resource intensity targeted to improve patients' systolic blood pressure (SBP) [top number of blood pressure measurement]. Medium/level 1 resource intensity: a registered nurse (RN) will provide monthly tailored behavioral support telephone calls + home BP monitoring. High/level 2 resource intensity: a pharmacist will provide monthly tailored behavioral support telephone calls + home BP monitoring + pharmacist-directed medication management. Booster (low) resource intensity: a licensed practical nurse (LPN) will provide non-tailored behavioral support telephone calls every two months to patients whose SBP comes under control. |
A LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months.
他の名前：
Monthly tailored RN delivered calls + home BP monitoring.
他の名前：
Pharmacist delivered telephone behavioral self-management support + Home BP monitoring with feedback to pharmacist + Algorithmic medication changes directed by pharmacist (with physician backup).
他の名前：
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アクティブコンパレータ：LPN Control
A LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months (identical to booster (low) resource intensity component of the titrated intervention).
The control arm will utilize the same procedures as the booster level for intervention patients for whom SBP comes under control.
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A LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months.
他の名前：
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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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Systolic Blood Pressure
時間枠：Baseline
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Continuous change in systolic blood pressure was measured as the primary outcome.
Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the baseline study visits.
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Baseline
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Systolic Blood Pressure
時間枠：6 months
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Continuous change in systolic blood pressure was measured as the primary outcome.
Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the 6- month study visits.
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6 months
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Systolic Blood Pressure
時間枠：12 months
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Continuous change in systolic blood pressure was measured as the primary outcome.
Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the12-month study visits.
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12 months
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Systolic Blood Pressure
時間枠：18 months
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Continuous change in systolic blood pressure was measured as the primary outcome.
Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the18- month study visits.
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18 months
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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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Number of Participants With Hypertension Control
時間枠：Baseline
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The investigators examined the difference in the degree of systolic BP control over the 18 months of the study between the intervention and control arms.
Control was defined as SBP < 130mmHg for hypertensive patients with diabetes and < 140mmHg for patients without diabetes.
Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the baseline study visit.
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Baseline
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Number of Participants With Hypertension Control
時間枠：6 months
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The investigators examined the difference in the degree of systolic BP control over the 18 months of the study between the intervention and control arms.
Control was defined as SBP < 130mmHg for hypertensive patients with diabetes and < 140mmHg for patients without diabetes.
Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the 6-month study visit.
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6 months
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Number of Participants With Hypertension Control
時間枠：12 months
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The investigators examined the difference in the degree of systolic BP control over the 18 months of the study between the intervention and control arms.
Control was defined as SBP < 130mmHg for hypertensive patients with diabetes and < 140mmHg for patients without diabetes.
Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the 12-study visit.
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12 months
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Number of Participants With Hypertension Control
時間枠：18 months
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The investigators examined the difference in the degree of systolic BP control over the 18 months of the study between the intervention and control arms.
Control was defined as SBP < 130mmHg for hypertensive patients with diabetes and < 140mmHg for patients without diabetes.
Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the18- month study visit.
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18 months
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Cost Effectiveness
時間枠：Over 18 months of study intervention
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One of our secondary research questions was: "If the intervention results in greater reduction in SBP than the control group, is it cost effective?" Intervention results did not show statistically significant differences between arms, therefore cost effectiveness analysis was not appropriate. While cost effectiveness was not analyzed because it was a null trial, the investigators would have used resource utilization and cost data from VA data sets to measure VA outpatient and inpatient utilization and costs by arms over 18 months. The investigators would have examined hypertension-related outpatient pharmacy prescription counts and costs in order to compare them to total outpatient pharmacy costs and the investigators would have examined inpatient utilization and costs. |
Over 18 months of study intervention
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Number of Participants Who Did Not Achieve Medication Adherence
時間枠：Baseline
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The investigators assessed adherence using patient self-report on a modified Morisky scale using 4 items:
A response of YES to any one of the 4 items indicated non-adherence, and responses of all no indicated adherence. The numbers in the descriptive tables reflect number non-adherent. |
Baseline
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Number of Participants Who Did Not Achieve Medication Adherence
時間枠：6 months
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The investigators assessed adherence using patient self-report on a modified Morisky scale using 4 items:
A response of YES to any one of the 4 items indicated non-adherence, and responses of all no indicated adherence. The numbers in the descriptive tables reflect number non-adherent. |
6 months
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Number of Participants Who Did Not Achieve Medication Adherence
時間枠：12 months
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The investigators assessed adherence using patient self-report on a modified Morisky scale using 4 items:
A response of YES to any one of the 4 items indicated non-adherence, and responses of all no indicated adherence. The numbers in the descriptive tables reflect number non-adherent. |
12 months
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Number of Participants Who Did Not Achieve Medication Adherence
時間枠：18 months
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The investigators assessed adherence using patient self-report on a modified Morisky scale using 4 items:
A response of YES to any one of the 4 items indicated non-adherence, and responses of all no indicated adherence. The numbers in the descriptive tables reflect number non-adherent. |
18 months
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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：George L Jackson, PhD MHA、Durham VA Medical Center, Durham, NC
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。
一般刊行物
- Jackson GL, Weinberger M, Kirshner MA, Stechuchak KM, Melnyk SD, Bosworth HB, Coffman CJ, Neelon B, Van Houtven C, Gentry PW, Morris IJ, Rose CM, Taylor JP, May CL, Han B, Wainwright C, Alkon A, Powell L, Edelman D. Open-label randomized trial of titrated disease management for patients with hypertension: Study design and baseline sample characteristics. Contemp Clin Trials. 2016 Sep;50:5-15. doi: 10.1016/j.cct.2016.07.009. Epub 2016 Jul 12.
- Jackson GL, Stechuchak KM, Weinberger M, Bosworth HB, Coffman CJ, Kirshner MA, Edelman D. How Views of the Organization of Primary Care Among Patients with Hypertension Vary by Race or Ethnicity. Mil Med. 2018 Sep 1;183(9-10):e583-e588. doi: 10.1093/milmed/usx111.
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 (実際)
2012年7月27日
一次修了 (実際)
2016年10月31日
研究の完了 (実際)
2016年10月31日
試験登録日
最初に提出
2011年7月6日
QC基準を満たした最初の提出物
2011年7月6日
最初の投稿 (見積もり)
2011年7月11日
学習記録の更新
投稿された最後の更新 (実際)
2019年2月11日
QC基準を満たした最後の更新が送信されました
2018年9月4日
最終確認日
2018年9月1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。