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テクノロジーを活用した慢性疾患ケアを提供する看護師の拡大 (EXTEND)

2026年9月9日 更新者：Duke University

The purpose of this study is to investigate whether the self-management of diabetes and hypertension can be improved with the use of mobile monitoring devices and nursing support.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

EXpanding Technology-Enabled, Nurse-Delivered Chronic Disease Care (EXTEND) seeks to address evidence gaps that prevent practical use of mobile monitoring-enabled telehealth for clinic-refractory chronic diseases, with an initial focus on Persistent Poorly Controlled Diabetes Mellitus (PPDM) and hypertension. Because our population has already proven refractory to usual care, we will conduct an active comparator randomized trial (N=220) of two 12-month interventions: 1) mobile monitoring as a self-management tool (EXTEND); and 2) a nurse-delivered intervention incorporating mobile monitoring, self-management support, and medication management (EXTEND Plus). The medication management is a care team approach where the nurse works with a Pharmacist who has prescribing rights to optimize medications for the patients. This proposal will also allow us to examine a novel application for mobile monitoring technologies, as tools for predicting patient safety events.

Aim 1: Compare the effectiveness of the two 12-month EXTEND interventions for PPDM and hypertension. Hypothesis 1a: Compared to EXTEND, EXTEND Plus will improve primary (HbA1c) and secondary outcomes (e.g., blood pressure, weight, self-management measures) at 12 months; Hypothesis 1b: The relative effects of each intervention will be sustained at 24 months; Hypothesis 1c: Subgroup analyses will identify characteristics associated with high responsiveness to each intervention.

Aim 2: Guide scaling and dissemination of the EXTEND interventions by: (A) interviewing patients and stakeholders to clarify implementation barriers, facilitators and process requirements; (B) comparing intervention costs against potential reimbursement mechanisms; and (C) understanding the role of climate change and other social drivers of health on diabetes self-management and intervention engagement.

Aim 3: Explore the value of combining mobile monitoring and EHR data for predicting patient safety events (hospitalizations, emergency visits) in the EXTEND study cohort over 24 months. Participants will monitor their data using a suite of remote monitoring devices. Data will be analyzed with PACE by our team. If participants are randomized to the telehealth arm, these data will be reviewed by a RN during a telehealth visit to aid in clinical decision making.

研究の種類

介入

入学 (実際)

220

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

  • アメリカ
    • North Carolina
      • Durham、North Carolina、アメリカ、27705
        • Duke University 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

30年～75年 (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:

  • type 2 diabetes by International Classification of Diseases (ICD) code or treatment with glucose-lowering medication or mention in clinical notes
  • Poor diabetes control as indicated by at least 1 HbA1c greater than or equal to 8.0% with NO HbA1c less than 8.0% over the past 6 months
  • At least 1 appointment (office visit, appointment, initial consult, telemedicine) at primary clinic site over the past year
  • hypertension by ICD code or treatment with blood pressure-lowering medication or mention in clinical notes
  • poor hypertension control as indicated by a clinic systolic BP >140 AND/OR diastolic BP >90 over past year
  • use of an Apple iPhone or Android smartphone
  • can provide informed consent
  • can read/speak English
  • can provide informed consent

Exclusion Criteria:

  • dementia, psychosis, or life-limiting illness
  • acute coronary event in past year
  • hypoglycemic seizure/coma over the past year
  • residence in a nursing home
  • use of an insulin pump
  • are or plan to become pregnant
  • unable or unwilling to use necessary technology to participate in study

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：独身

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：EXTEND

EXTEND participants receive 4 mobile monitoring devices to facilitate chronic disease self-management (glucometer, BP cuff, scale, accelerometer). Device data are transferred to Duke University Health System (DUHS). Participants can review data and trends within the device apps and modify self-management practices accordingly. The EXTEND group continues chronic disease care with their existing providers during the study, and are instructed at baseline to address management questions via their primary clinics' established avenues (as would be the case for any patient using mobile monitoring in clinical practice).
行動：EXTEND

EXTEND patients self-manage using data they collect during the study, and continue to receive standard behavioral counseling from primary providers.
実験的：EXTEND Plus

EXTEND Plus participants receive 4 mobile monitoring devices to facilitate chronic disease self-management (glucometer, BP cuff, scale, accelerometer). Device data are transferred to Duke University Health System (DUHS) for use as part of nurse-delivered intervention combining mobile monitoring, self-management support, and medication management. The intervention is administered by clinical registered nurses (RNs) from Duke Primary Care (DPC) or Duke Endocrinology. For the medication management component, RNs work with a study PharmD affiliated with the participant's clinic. The PharmD determines if medication changes are needed, and prescribes accordingly. The RNs deliver EXTEND Plus via scheduled telephone encounters throughout the 12-month intervention. The initial encounter frequency is every two weeks, but may be extended to every four weeks for patients achieving treatment goals.
行動：EXTEND Plus

The EXTEND Plus approach builds patient self-management capacity by focusing on knowledge, self-efficacy, and goal setting (using an RN-delivered, module-based approach). All material is at an 8th grade reading level. Module topics include, but are not limited to, use of self-monitoring of blood glucose (SMBG), BP monitoring, developing a diet plan, medication adherence, hypoglycemia and hypotension self-management, and self-managing insulin. In addition, this intervention component addresses diet and activity self-management during each encounter.

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
Change in HbA1c
時間枠：Baseline, 3, 6, 9, 12, 18 and 24 months

Change in blood sugar (glucose) attached to hemoglobin. Validated point-of-care or lab-based test.
Baseline, 3, 6, 9, 12, 18 and 24 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Systolic Blood Pressure
時間枠：Baseline, 3, 6, 9, 12, 18 and 24 months

Measure taken at clinic with standard arm cuff. Measurement is the average of two readings, on the same arm, taken 10 minutes apart.
Baseline, 3, 6, 9, 12, 18 and 24 months
Change in Diastolic Blood Pressure
時間枠：Baseline, 3, 6, 9, 12, 18 and 24 months

Measure taken at clinic with standard arm cuff. Measurement is the average of two readings, on the same arm, taken 10 minutes apart.
Baseline, 3, 6, 9, 12, 18 and 24 months
Change in Weight
時間枠：Baseline, 3, 6, 9, 12, 18 and 24 months

Measurement taken with lab scale, when patient is lightly clothed, shoes off.
Baseline, 3, 6, 9, 12, 18 and 24 months
Change is Diabetes Distress Scale
時間枠：Baseline, 6, 12, 18 and 24 months

Measure of diabetes distress and burden using the Diabetes Distress Scale (DDS): 17 items, Scale 1-6. Scoring: Average. Higher score indicates higher distress level.
Baseline, 6, 12, 18 and 24 months
Change in Diabetes Self-Management Questionnaire
時間枠：Baseline, 6, 12, 18 and 24 months

Measure of diabetes self-care. Diabetes Self-Management Questionnaire (DSMQ): 16 items, Scale 0-3. Scoring: Sum and transform to fall between 0-10. Higher score indicates more effective self-care.
Baseline, 6, 12, 18 and 24 months
Change in Perceived Competence Scale
時間枠：Baseline, 6, 12, 18 and 24 months

Measure of diabetes self-efficacy and capacity. Perceived Competence Scale (PCS): 4 items, Scale 1-7. Scoring: average (1-7) Higher score indicates greater self-efficacy.
Baseline, 6, 12, 18 and 24 months
Change in Medication Non-adherence
時間枠：Baseline, 6, 12, 18 and 24 months

Validated self-report measure using Voils' medication non-adherence measure.

Voils

  1. Full name: Voils Medication Nonadherence Measure
  2. Construct: assesses how often a patient misses their prescribed medication and why
  3. Scale range: 1-5 (the scale consists of 6 likert scale items ranging from 1=None of the time to 5=Every time. The total score is obtained by taking the mean of the items)
  4. Higher scores indicate greater medication non-adherence.
  5. There are no subscales.
Baseline, 6, 12, 18 and 24 months
Change in Diabetes Knowledge
時間枠：Baseline, 6, 12, 18 and 24 months

Diabetes Knowledge Questionnaire (DKQ) is a 24-item validated measure.

Diabetes Knowledge

  1. Full name: Diabetes Knowledge Questionnaire
  2. Construct: assesses diabetes knowledge
  3. Scale range: 0-24 (the scale consists of 24 yes-no items that assess diabetes knowledge. One point is given for each item answered correctly.)
  4. Greater scores indicate greater knowledge of diabetes
  5. There are no subscales.
Baseline, 6, 12, 18 and 24 months

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。

スポンサー

Duke University

協力者

National Institute of Nursing Research (NINR)

捜査官

  • 主任研究者：Ryan J Shaw, RN, PhD、Duke University School of Nursing
  • 主任研究者：Matthew Crowley, MD、Duke University

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

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)

2022年4月21日

一次修了 (実際)

2025年8月13日

研究の完了 (実際)

2025年8月13日

試験登録日

最初に提出

2021年11月3日

QC基準を満たした最初の提出物

2021年11月3日

最初の投稿 (実際)

2021年11月15日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月1日

QC基準を満たした最後の更新が送信されました

2026年9月9日

最終確認日

2025年10月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • PRO00107722
  • 1R01NR019594-01 (米国 NIH グラント/契約)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

Our data will be made available for use by investigators not associated with the proposed study within 3 years after the primary results have been published. We will prepare a clear and searchable documentation of the database including a data dictionary, and its linkage to the pertinent study protocols and forms so that diverse investigators can make effective use of the data. For investigators interested in prospective collaborations, we will explore other options to provide support.

IPD 共有時間枠

Within 3 years of study data publication.

IPD 共有アクセス基準

For all prospective opportunities (e.g., access to datasets, collaborative studies), we will widely advertise them on Duke Websites and at appropriate scientific meetings.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

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米国FDA規制機器製品の研究

いいえ

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