Young Adult Hypertension Feasibility Study (myHEART)
myHEART (My Hypertension Education and Reaching Target) Program: a Feasibility Study of a Young Adult Hypertension Intervention
調査の概要
詳細な説明
To address the unmet need for hypertension care in young adults, MyHEART (My Hypertension Education and Reaching Target), a multi-component hypertension intervention was developed. Eligible patients were identified via the healthcare system's electronic health record.
Inclusion criteria included:
- 18-39 years old at the start of the study,
- previous hypertension ICD-9 coded office visits and
- uncontrolled hypertension (≥140/90 mmHg) based on the last ambulatory blood pressure reading.
Exclusion criteria included a pre-defined list of co-morbidities, in addition to planned or current pregnancy, any health condition that limits physical activity or dietary changes, current participation in another study, and planning to leave the area in the next three months. During the feasibility study, all participants continued to receive usual hypertension care from their primary care provider. The intervention involved health coach calls over a 3-month period using self-management modules. The order of the modules was guided by the participant's choice. All encounters were documented in the electronic health record. Patient acceptability and home blood pressure monitoring survey data was acquired.
研究の種類
入学 (実際)
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:
- 18-39 years old at the start of the study
- previous hypertension ICD-9 coded office visits
- uncontrolled hypertension (≥140/90 mmHg) based on the last ambulatory blood pressure reading
Exclusion Criteria:
- Chronic Kidney Disease (Stage 4 or 5 or Dialysis)
- Congestive Heart Failure, Any Etiology
- Activated Healthcare Power of Attorney
- Skilled nursing facility or correctional facility residence
- Currently enrolled in case management or chronic disease management support services
- Sensitive condition diagnosis (e.g. HIV)
- Prescribed warfarin, novel oral anticoagulant, or insulin
- Diagnosis of sickle cell anemia or cystic fibrosis
- Prior stroke, myocardial infarction, coronary artery revascularization
- Syncope within past 12 months
- Prior or planned organ transplant
- Chemotherapy or radiation therapy within 6 months
- Severely impaired hearing or speech
- Current participation in another research study
- Pregnant/planning to become pregnant in the next 12 months
- Planning to leave the area in the next 3 months
- Any health condition that will limit physical activity or dietary changes
- Illegal drug use (other than marijuana) in the past 30 days (Self-report)
- Unable to read or communicate in English
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：なし
- 介入モデル：単一グループの割り当て
- 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：Intervention
Telephone health coaching over 3 months with supporting education materials.
|
Self-management education
|
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 |
|---|---|---|
|
Patient Satisfaction
時間枠：3 months
|
Patient satisfaction survey of feasibility study
|
3 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Out-of-clinic blood pressures
時間枠：3 months
|
Frequency of home or out-of-clinic blood pressure monitoring
|
3 months
|
協力者と研究者
捜査官
- 主任研究者：Heather M Johnson, MD, MS、University of WI School of Medicine and Public Health
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
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。