Empowering Patients to Better Manage Diabetes Through Self-Care
調査の概要
状態
詳細な説明
The objective of this particular study is to determine if the addition of regular pharmacist visits to usual care can improve clinical outcomes in patients with diabetes. The central hypothesis is that a program overseen by community pharmacists that empowers patients to self-manage their diabetes will lead to improved clinical and humanistic outcomes and will be cost-effective. Strong preliminary data collected from other sites suggests that patient empowerment programs are effective at reducing hemoglobin A1C after 12 months and in reducing the total cost of care. This hypothesis will be tested by pursuing three specific aims to evaluate the impact of a pharmacist-administered diabetes patient empowerment program on:
- clinical markers for diabetes and related metabolic disorders;
- the cost of care and resource utilization; and
- patient knowledge and perceived ability to manage diabetes. There is an additional specific aim to assess the pharmacists with respect to satisfaction with the training program and the overall project, the activities conducted in patient sessions, and the time taken to complete the visits in this study.
研究の種類
入学 (実際)
段階
- フェーズ 3
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:
- diabetes (Type I or Type II)
- enrolled in health plan with participating employer
- age 18 or older
- willing and able to provide informed consent
Exclusion Criteria:
- gestational diabetes
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：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：Usual Care plus out-of-pocket cost waiver
Patients received educational materials (handouts) in the mail.
This was assumed to be of minimal effectiveness.
Patients also received waiver of out-of-pocket expenses for diabetes care.
|
Patients received educational materials (handouts) in the mail.
This was assumed to be of minimal effectiveness.
Patients also received waiver of out-of-pocket expenses for diabetes care.
|
|
実験的：EMPOWER
Patients were scheduled for free counseling with pharmacists including medication, diet, and other self-management items.
Patients also received waiver of out-of-pocket expenses for diabetes care.
|
Patients were scheduled for free counseling with pharmacists including medication, diet, and other self-management items.
Patients also received waiver of out-of-pocket expenses for diabetes care.
|
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 Hemoglobin A-1C From Baseline
時間枠：baseline and 12 months
|
Compare changes in Hemoglobin A-1C from baseline between the two groups.
|
baseline and 12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes From Baseline in LDL, HDL, Total Cholesterol, Triglycerides
時間枠：baseline and 12 months
|
Changes from baseline in LDL, HDL, total cholesterol, triglycerides. Sample sizes for each individual test (usual care plus out-of-pocket cost waiver; EMPOWER group):
|
baseline and 12 months
|
|
Changes in Economic Outcomes (Total Cost of Care, Cost of Diabetes Medications, Cost of Diabetes Supplies) From Baseline to 12 Months
時間枠：baseline to 12 months
|
Changes in claims-based economic data on costs of total health care, diabetes medications, and diabetes supplies from baseline to 12 months. Only participants who had a claim in the 12 months prior to baseline were included in these analyses. The resulting sample sizes (usual care plus out-of-pocket cost waiver; EMPOWER group) for these outcomes are:
|
baseline to 12 months
|
|
Change in Diabetes Knowledge and Empowerment (Patient Self-efficacy) From Baseline to 12 Months
時間枠：From baseline to 12 months
|
Psycho-social aspects of diabetes knowledge and empowerment. Sample sizes are in parentheses (usual care plus out-of-pocket cost waiver; EMPOWER group):
|
From baseline to 12 months
|
協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Dale F Kraemer, Ph.D.、Oregon State University, College of Pharmacy
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 (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。