Improving Diabetes Outcomes With Activity, Nutrition and Medication
Improving Diabetes Medication Adherence and Outcomes
This study has the following specific aims:
- A tailored telephone intervention will significantly improve medication adherence compared to a standard care intervention.
- A tailored telephone intervention will significantly improve metabolic control measured by HbA1c compared to a standard care intervention 2a) We will explore ways to link behavior change for medication adherence with lifestyle modification for diet and physical activity.
- To conduct cost evaluations for the telephone intervention vs. standard care.
調査の概要
状態
条件
詳細な説明
Metabolic control of type 2 diabetes and prevention of its complications are related to management of blood glucose and other factors. Medication and lifestyle modifications are integral to most self-management plans; however, adherence remains a great challenge. Many patients have abnormal HbA1c, blood pressure and lipid values, and are at greater risk for complications. This study is to evaluate the effectiveness and costs of a tailored, telephone intervention to promote adherence in middle-aged and older adults with type-2 diabetes who are members of a union/employer-sponsored health benefit plan. The target population includes English- and Spanish-speaking individuals from the health plan database.
This study has the following specific aims:
- A tailored telephone intervention will significantly improve medication adherence compared to a standard care intervention.
- A tailored telephone intervention will significantly improve metabolic control measured by HbA1c compared to a standard care intervention 2a) We will explore ways to link behavior change for medication adherence with lifestyle modification for diet and physical activity.
- To conduct cost evaluations for the telephone intervention vs. standard care. The study design is a randomized, controlled intervention trial with masking; the individual is the unit of sampling, assignment and analysis. After eligibility is assessed and consent is obtained by telephone, patients will be randomized to either the telephone intervention or standard are. Study outcomes will be medication adherence as measured from pharmacy records and metabolic control (HbA1c). A total of 556 patients with type 2 diabetes wil be randomized, which will provide 80% power to detect a statistically significant difference in HbA1c of at least 0.3%, and over 95% power to detect a difference in filled prescriptions. Telephone surveys will provide data on self-care behaviors including diet and exercise, risk perceptions, and depressive symptoms. Cost data will be collected using standardized methods. Study results will inform implementation of practical, nurse-managed interventions to improve medication adherence and metabolic control in diverse, middle-aged and older, type 2 diabetes patients, while linking changes in medication adherence to lifestyle modification for diet and physical activity.
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
-
-
New York
-
Bronx、New York、アメリカ、10461
- Albert Einstein College Of Medicine
-
-
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:
- Type 2 diabetes
- Taking oral diabetes medication
- At least 40 years old
- In a union-sponsored health plan with full medication coverage for at least a year
- Able to understand English or Spanish
- Informed consent
Exclusion Criteria:
- Currently in a diabetes education program
- Will lose health care eligibility within a year
- Unable to receive phone calls or mail
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:他の
- 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 |
---|---|
実験的:1
Tailored telephone intervention plus mailed print educational materials
|
Tailored telephone intervention to promote metabolic control of diabetes
|
アクティブコンパレータ:2
print intervention with no telephone component
|
diabetes educational materials by mail
|
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 |
時間枠 |
---|---|
Medication adherence
時間枠:1 year
|
1 year
|
Metabolic control (measured by HbA1c)
時間枠:1 year
|
1 year
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
Changes in self-care behaviors including diet and exercise
時間枠:1 year
|
1 year
|
Cost evaluations
時間枠:1 year
|
1 year
|
協力者と研究者
協力者
捜査官
- 主任研究者:Elizabeth A Walker, DNSc, RN、Albert Einstein College Of Medicine
- 主任研究者:Hillel W Cohen, DrPH, MPH、Albert Einstein College Of Medicine
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。