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Enhancing Self-Management Support in Diabetes Through Patient Engagement (EE-CTH)

2021年2月19日 更新者:University of California, San Francisco

The Patient Centered Medical Home (PCMH) and the Chronic Care Model (CCM) are complementary clinical intervention frameworks that are commonly invoked to support better type 2 diabetes (T2DM) outcomes in primary care. Self-management Support (SMS) is a core component of both the PCMH and CCM, and focuses on the central role of patients in managing their illness by engaging with and adopting healthy behaviors that promote optimal clinical outcomes. Despite its recognized importance, SMS programs for diabetes continue to demonstrate limited effectiveness in the real-world of primary care.

SMS is comprised of two complementary and interactive components: (1) patient engagement (e.g., the process of eliciting and responding to patients emotions and motivations related to health behaviors), and (2) behavioral change tools (e.g., selecting specific goals, creating action plans). While several sophisticated SMS programs have been developed for T2DM, the vast majority are designed with a narrow focus on behavioral change tools, largely ignoring unique aspects of the patient context that drive and maintain health behavior. Considerable clinical research suggests that the addition of a structured, evidenced-based program of patient engagement can maximize the effectiveness of SMS programs for patients with T2DM in primary care.

To date there has been no systematic study of the degree to which fully integrating enhanced patient engagement as part of SMS will increase the initiation and maintenance of behavior change over time, and for which kinds of patients enhanced patient engagement is essential. To address this gap, the investigators will compare a state-of-the-art, evidence-based SMS behavior change tool program, called Connection to Health (CTH), with an enhanced CTH program that includes a practical, time-efficient patient engagement protocol, to create a program with an integrated and comprehensive approach to SMS, called "Enhanced Engagement CTH" (EE-CTH). The current study will directly test the added benefit of EE-CTH to CTH with regard to self-management behaviors and glycemic control in resource-limited community health centers, where vast numbers of patients with T2DM from ethnically diverse and medically vulnerable populations receive their care. The investigators will use an effectiveness-implementation hybrid design, employing the "Reach Effectiveness Adoption Implementation Maintenance" (RE-AIM) framework to test these two SMS programs for T2DM. This will provide critical information that will support dissemination and implementation of effective SMS programs in resource-limited primary care settings, serving diverse and medically vulnerable populations with much to gain from improved SMS.

調査の概要

詳細な説明

This is a two-arm, 14 month pragmatic cluster randomized trial to evaluate the added benefit of EE-CTH relative to CTH for patients with T2DM in primary care.

Primary care practices (not patients) will be randomly assigned to receive and deliver CTH or EE-CTH in an innovative effectiveness-implementation hybrid design. Using the RE-AIM framework, the investigators will evaluate program effectiveness in a real world setting, while at the same time gathering information on program reach, adoption, implementation and maintenance. CTH and EE-CTH practice trainings and delivery will each follow separate and standardized protocols, with support provided to practices through staff training, ongoing supervision and case presentations, and a practice improvement team assisted by a practice facilitator to address issues of staffing and patient flow. Practice training and facilitation notes, in conjunction with feedback from patient advisory councils, will be captured and integrated to identify barriers and facilitators to the implementation process and inform dissemination efforts. Beyond the requirements of the study, practices will be permitted to use EE-CTH or CTH with other patients as wished, which will enable the investigators to document the program's reach within the practice. Patients in both study arms will receive the intervention at a minimum of two primary care appointments (baseline and follow-up between 6 and 12 months).

研究の種類

介入

入学 (実際)

725

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

    • California
      • San Francisco、California、アメリカ、94143
        • University of California, San Francisco

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

21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:

  • Type 2 diabetes;
  • Diagnosed and receiving care at participating practices for at least 12 months;
  • Able to read in English or Spanish (at least 6th grade level).

Exclusion Criteria:

  • Not meeting all inclusion criteria

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: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
アクティブコンパレータ:Connection to Health (CTH)
CTH is a comprehensive SMS program that focuses on behavior change. CTH utilizes web-based interactive behavior change technology, based on a logic model of behavior and maintenance that is informed by social-cognitive and social ecological theories. Prior to diabetes visits with a clinician, health educator, or care manager, patients complete a pre-visit CTH assessment at their practice through a tablet computer or computer kiosk. CTH assesses multiple diabetes management behaviors (diet, physical activity, medication adherence, alcohol and tobacco use, stress, mood) using brief assessment measures, each with cut-points highlighting areas of deficit. Action planning plays a central role, through a web-based platform that allows the patient and health care team to select and set goals collaboratively.
CTH is a comprehensive SMS program that focuses on behavior change.
実験的:Enhanced Engagement Protocol for CTH (EE-CTH)
EE-CTH seamlessly integrates CTH with an efficacious, structured, motivational interview (MI)-informed protocol specifically designed to enhance patient engagement in SMS activities. Key components of MI have been incorporated into a practical and systematic engagement protocol that includes: (1) acknowledging the patient's point of view; (2) identifying and labeling the patient's ambivalence (both the good reasons for making the change and the good reasons for not making the change); (3) evaluating whether change is really worth the effort; (4) identifying, reflecting and labeling accompanying feelings and concerns about change; and (5) establishing a small and meaningful goal by the end of the encounter.
EE-CTH integrates CTH with an efficacious, structured, motivational interview (MI)-informed protocol.

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
HbA1c (glycated haemoglobin)
時間枠:Change from baseline to follow-up (6 to 12 months)
Percentage HbA1c
Change from baseline to follow-up (6 to 12 months)
High fat food
時間枠:Change from baseline to follow-up (6 to 12 months)
Amount of high fat food consumed weekly adapted from the Summary of Diabetes Self-Care Activities
Change from baseline to follow-up (6 to 12 months)
Physical activity
時間枠:Change from baseline to follow-up (6 to 12 months)
Number of minutes of participation in physical activity from the International Physical Activity Questionnaire
Change from baseline to follow-up (6 to 12 months)
Number of days missed medications
時間枠:Change from baseline to follow-up (6 to 12 months)
Number of days missed missing one or more medications in the past 14 days
Change from baseline to follow-up (6 to 12 months)
Medication adherence
時間枠:Change from baseline to follow-up (6 to 12 months)
Frequency of reasons for missing medications.
Change from baseline to follow-up (6 to 12 months)
Fruit and vegetable intake
時間枠:Change from baseline to follow-up (6 to 12 months)
Number of daily fruit and vegetable servings adapted from the Summary of Diabetes Self-Care Activities
Change from baseline to follow-up (6 to 12 months)
Sugar-sweetened beverages
時間枠:Change from baseline to follow-up (6 to 12 months)
Number of daily sugar-sweetened beverages from the Starting the Conversation Measure
Change from baseline to follow-up (6 to 12 months)

二次結果の測定

結果測定
メジャーの説明
時間枠
Health-related distress
時間枠:Change from baseline to follow-up (6 to 12 months)
Modified from the Diabetes Distress Scale
Change from baseline to follow-up (6 to 12 months)
Depression symptoms
時間枠:Change from baseline to follow-up (6 to 12 months)
Patient Health Questionnaire (PHQ8) Score
Change from baseline to follow-up (6 to 12 months)
Weight
時間枠:Change from baseline to follow-up (6 to 12 months)
Weight (pounds)
Change from baseline to follow-up (6 to 12 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。

捜査官

  • 主任研究者:Danielle M Hessler, Ph.D.、University of California, San Francisco

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)

2016年10月1日

一次修了 (実際)

2020年12月20日

研究の完了 (実際)

2020年12月20日

試験登録日

最初に提出

2016年7月6日

QC基準を満たした最初の提出物

2016年7月14日

最初の投稿 (見積もり)

2016年7月15日

学習記録の更新

投稿された最後の更新 (実際)

2021年2月23日

QC基準を満たした最後の更新が送信されました

2021年2月19日

最終確認日

2021年2月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 15-17033
  • R18DK108039-05 (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?

いいえ

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。

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Connection to Health (CTH)の臨床試験

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