Remote Monitoring and Virtual Collaborative Care For Hypertension Control To Prevent Cognitive Decline (vCCC)
2021年7月7日 更新者：Jeff Burns, MD、University of Kansas Medical Center
Remote Monitoring and Virtual Collaborative Care For Hypertension Control To Prevent Cognitive Decline: Phase I
This purpose of this study is to examine an aggressive method of blood pressure control that involves home blood pressure monitoring and management of medications by a team of clinical pharmacists in coordination with a primary care physician.
調査の概要
研究の種類
介入
入学 (実際)
33
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
-
-
Kansas
-
Kansas City、Kansas、アメリカ、66106
- University of Kansas Medical Center
-
-
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
65年歳以上 (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 65 and older
- Active patient in participating primary care clinic
- Access to compatible "smartphone" or device (i.e., Android, Kindle or Apple with internet connectivity)
- Elevated blood pressure as defined by:
Systolic Blood Pressure >140 at current visit AND documented history of hypertension OR Systolic Blood Pressure > 140 at current visit and at another visit in last 18 months OR Systolic Blood Pressure >160 at current visit
- Sufficiently fluent in English to participate in study procedures
- Adequate vision and hearing to complete study procedures
Exclusion Criteria:
- Clinically significant illness that may affect safety or completion per their treating Primary Care Physician or study physician
- End stage renal disease on dialysis
- Chronic active disease with expected life expectancy < 2 years as determined by the study team
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：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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Virtual Collaborative Care Clinic
The Virtual Collaborative Care Clinic arm participants use a home blood pressure monitor and routine blood pressure measurements will be uploaded to a dashboard monitored by clinical pharmacists.
Blood pressure will be managed aggressively by the clinical pharmacists in coordination with Primary Care Physicians.
|
The vCCC will operate under a collaborative care agreement with the Primary Care Physicians as an extension (and not a replacement) of their care.
Trained clinical pharmacists will monitor blood pressure and prescribe and adjust medications under the license of, and in communication with, the patient's Primary Care Physician.
As part of the Primary Care Physician's team and per Primary Care Physician's directions, the pharmacists may coordinate blood pressure management with other clinicians such as cardiologists or nephrologists co-managing patients blood pressure.
|
|
介入なし：Control Intervention
The control intervention will consist of providing the participant with educational material and a home blood pressure monitor.
The patients in the control group will not have support from Virtual Collaborative Care Clinic pharmacists.
Routine blood pressure measures using their device will not be collected via the dashboard and will not be available for pharmacist review.
Participants will continue to see their physicians for their usual care for blood pressure management.
|
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 |
|---|---|---|
|
Feasibility of system wide adoptability as assessed by survey responses
時間枠：Baseline
|
Primary Care Physicians and vCCC Pharmacists will be asked for feedback on feasibility of implementation via a survey.
The vCCC pharmacists and PCPs will be surveyed to assess feasibility and changing views of feasibility.
Brief, validated scales will be delivered via email (REDCap surveys) to assess the construct of feasibility.
|
Baseline
|
|
Feasibility of system wide adoptability as assessed by survey responses
時間枠：3 Months Post Baseline
|
Primary Care Physicians and vCCC Pharmacists will be asked for feedback on feasibility of implementation via a survey.
The vCCC pharmacists and PCPs will be surveyed to assess feasibility and changing views of feasibility.
Brief, validated scales will be delivered via email (REDCap surveys) to assess the construct of feasibility.
|
3 Months Post Baseline
|
|
Feasibility of system wide adoptability as assessed by Physician Advisory Board meetings discussion
時間枠：Through study completion, an average of 9 months
|
Members of the Physician Advisory Board will be asked for feedback on system wide adoptability during the monthly Physician Advisory Board meetings.
The meetings will be recorded and summarized.
|
Through study completion, an average of 9 months
|
|
Feasibility of system wide adoptability as assessed by vCCC Pharmacist Interviews
時間枠：Up to 2 months Post Baseline
|
Virtual Collaborative Care Clinic Pharmacists will be asked for feedback on feasibility of system wide adoption.
We will conduct one-time semi-structured qualitative interviews with the Virtual Collaborative Care Clinic pharmacists.
The Virtual Collaborative Care Clinic pharmacist will be interviewed to assess implementation factors including the auto-referral process and open-ended questions on the process and suggestions for improvement.
|
Up to 2 months Post Baseline
|
|
Replicability to other health systems as assessed by survey responses
時間枠：Baseline
|
Primary Care Physicians and vCCC Pharmacists will be asked for feedback on replicability to other health systems via a survey.
Brief, validated scales will be delivered via email (REDCap surveys) to assess the construct of replicability to other health systems.
|
Baseline
|
|
Replicability to other health systems as assessed by survey responses
時間枠：3 Months Post Baseline
|
Primary Care Physicians and vCCC Pharmacists will be asked for feedback on replicability to other health systems via a survey.
Brief, validated scales will be delivered via email (REDCap surveys) to assess the construct of replicability to other health systems.
|
3 Months Post Baseline
|
|
Replicability to other health systems as assessed by Physician Advisory Board meetings discussion
時間枠：Through study completion, an average of 9 months
|
Members of the Physician Advisory Board will be asked for feedback on replicability to other health systems during the monthly Physician Advisory Board meetings.
The meetings will be recorded and summarized.
|
Through study completion, an average of 9 months
|
|
Replicability to other health systems as assessed by vCCC Pharmacist Interviews
時間枠：Up to 2 months Post Baseline
|
vCCC Pharmacists will be asked for feedback on replicability to other health systems.
We will conduct one-time semi-structured qualitative interviews including open-ended questions.
|
Up to 2 months Post Baseline
|
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：Jeffrey Burns, MD、University of Kansas Medical Center
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)
2020年10月20日
一次修了 (実際)
2021年7月2日
研究の完了 (実際)
2021年7月2日
試験登録日
最初に提出
2020年9月30日
QC基準を満たした最初の提出物
2020年10月9日
最初の投稿 (実際)
2020年10月14日
学習記録の更新
投稿された最後の更新 (実際)
2021年7月9日
QC基準を満たした最後の更新が送信されました
2021年7月7日
最終確認日
2021年7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。
Virtual Collaborative Care Clinicの臨床試験
-
University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); University... と他の協力者招待による登録