Provider-Initiated Regular Remote Interventions for Optimal Type 2 Diabetes Care
Patients with type 2 diabetes can attain superior disease outcomes if multiple therapy goals are simultaneously achieved and maintained. In reality, therapy goals are seldom achieved, and patients become susceptible to devastating complications and greater health care expenses. Studies have shown that regular monitoring and therapy adjustments are a prerequisite to achieving and maintaining therapy goals. Unfortunately implementation of regular monitoring and therapy adjustments have been hindered by high clinic workload and shortage of endocrinologists. Due to this shortage, endocrine care is accessible to less than 20% of patients with type 2 diabetes. The overwhelming majority are managed by providers who may lack the necessary expertise or time to deliver optimal disease management, particularly when insulin is prescribed.
Objectives: We hypothesize that type 2 diabetes endocrine clinics for high-risk patients that complement primary care, personalize the frequency of remote disease interventions and employ infrequent face-to-face outpatient visits, will achieve comparable clinical outcomes and patient satisfaction compared to usual endocrine clinic care, while reducing workload and increasing the clinic capacity. The intervention clinic will employ regular remote communications initiated by the endocrinologists, based on tailored individual plans. Frequent remote monitoring and interventions will reinforce attainment of the therapy goals and allow a decrease in the frequency of outpatient visits. In turn, the clinic workload will decrease and it will be able to accommodate more patients with type 2 diabetes than traditional endocrine clinics. The aims of the study are to test this new endocrine clinic model in a clinical trial by monitoring clinical parameters, patient satisfaction and clinical workload. The long-term objectives are to modify the current model of endocrine care for patients with type 2 diabetes.
調査の概要
詳細な説明
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Michigan
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Ann Arbor、Michigan、アメリカ、48109
- University of Michigan Health System
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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:
- Men or women aged ≥18 years of age;
- Clinical diagnosis of type 2 diabetes (as defined by the American Diabetes Association 2);
- Treated with insulin or at least two diabetes medications;
- Have A1C ≥8.0% and ≤11.0%;
- Able and willing to use telephone or other sorts of communication regularly between clinic visits.
Exclusion Criteria:
- Do not speak English;
- Unwilling or unable to provide informed consent;
- Have any condition associated with life expectancy of less than 3 years;
- Have an active mental illness or substance abuse
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: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:Personalized type 2 diabetes care.
Remote, personalized type 2 diabetes clinic provided by an endocrinologist using frequent remote contacts for medication adjustments.
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Diabetes and comorbidities will be managed with 1 clinic visit per year and frequent adjustments made remotely.
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アクティブコンパレータ:Usual Endocrine Care
Usual Endocrine care will be provided by an endocrinologist.
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Diabetes and comorbidities management will provided by an endocrinologist
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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 |
|---|---|---|
|
Change in baseline A1C (glycated hemoglobin) at 12 months
時間枠:12 months
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Measure of long-term blood glucose control and efficacy of intervention
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12 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 |
|---|---|---|
|
Change in baseline lipids at 12 months
時間枠:12 months
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Measure of total cholesterol, LDL, and Triglycerides
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12 months
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Change in baseline blood pressure at 12 months
時間枠:12 months
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Systolic and diastolic blood pressure
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12 months
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All cause mortality
時間枠:12 months
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Record deaths due to any cause
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12 months
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Acute complications
時間枠:12 months
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Cardiovascular events, cerebrovascular events, peripheral vascular events, limb ulcers and amputations, severe hypoglycemia, and other unscheduled emergency department and hospital visits
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12 months
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Change in baseline Quality of life at 12 months
時間枠:12 months
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Short Form-36
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12 months
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Change in baseline insulin satisfaction at 12 months
時間枠:12 months
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Insulin Therapy Satisfaction Questionnaire
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12 months
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Clinic retention
時間枠:12 months
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Missed visits, missed phone calls, lost to follow up and drops outs will be recorded for both groups
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12 months
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Cost
時間枠:12 months
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Resource utilization and cost for both groups
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12 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Israel Hodish, MD, PhD、University of Michigan
出版物と役立つリンク
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 (実際)
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。