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Improving Medication Adherence in the Alabama Black Belt

2020年10月6日 更新者:Weill Medical College of Cornell University
Medication adherence is especially critical in regions like rural Alabama, where residents have among the worst health outcomes in the US. This project was designed in collaboration with our community member partners and builds on a 5-year partnership of community-engaged research on diabetes peer coaching interventions and our experience with peer storytelling. The investigators will test the hypothesis that an intervention designed within the Corbin and Strauss framework can improve adherence and health outcomes compared to usual care.

調査の概要

詳細な説明

Improving medication adherence is one of the greatest challenges in modern medicine. Despite decades of research on the topic, as many as half of patients with chronic diseases are not taking medications as recommended, and costs of nonadherence have been estimated at $290 billion annually. One reason for this persistent finding could be that interventions rarely acknowledge medications within the larger context of the lived experience of illness. Drawing on hundreds of patient interviews, Corbin and Strauss showed that chronic illness is a fundamentally destabilizing influence that forces us to confront the potential limitations of our "new", chronically ill self. Accepting our illness may be a crucial step in embracing medication adherence and other self-management behaviors as ways to restore balance following this disruption. The Corbin and Strauss framework is not often used to develop and test interventions to improve medication adherence, and this is the central objective of this proposal.

Medication adherence is especially critical in regions like rural Alabama, where residents have among the worst health outcomes in the US. Rates of cardiovascular mortality, diabetes and obesity are very high, but resources are scarce and the area's predominately black residents have deep-seated mistrust of the healthcare system (the region includes Tuskegee, site of the infamous syphilis study). This project was designed in collaboration with our community member partners and builds on a 5-year partnership of community-engaged research on diabetes peer coaching interventions and our experience with peer storytelling. The investigators will test the hypothesis that an intervention designed within the Corbin and Strauss framework can improve adherence and health outcomes compared to usual care. Our Aims are:

Aim 1: With our community partners, using qualitative research methods, build on already developed culturally tailored education material to develop the medication adherence intervention. The intervention will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching. Activities include conducting focus groups with patients; creating the DVDs and the coaching intervention protocol; training peer coaches; and pilot testing.

Aim 2: Conduct a randomized controlled trial with 500 individuals with type 2 diabetes and medication nonadherence. The trial will compare the effect of usual care and the intervention on medication adherence and physiologic risk factors including A1c, blood pressure and low density lipoprotein cholesterol (primary outcomes), and quality of life and self-efficacy (secondary outcomes).

This innovative approach would be a major shift in how patients are helped in under resourced areas living with chronic diseases commit to taking medications, improving health and eventually reducing health disparities.

研究の種類

介入

入学 (実際)

473

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

    • Alabama
      • Birmingham、Alabama、アメリカ、35210
        • Univeristy of Alabama at Birmingham

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

19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:

  • adults
  • type 2 diabetes
  • taking medications for diabetes
  • medication non adherent

Exclusion Criteria:

  • nursing home residence
  • plans to move away in the next year
  • advanced illnesses such as hemodialysis, cancer or dementia

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
実験的:Peer Coaching
The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching.
The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching
介入なし:Usual Care
At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs.

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 Self Reported Medication Adherence
時間枠:Baseline, 6 months
Patient-reported adherence to medications as a medication adherence score, from 0-3, where a higher score indicates worse adherence.
Baseline, 6 months
Change in Percentage of HbA1c
時間枠:Baseline, 6 months
Hemoglobin A1c test to identify the average amount of glucose (sugar) present in a patient's blood.
Baseline, 6 months
Change in Blood Pressure
時間枠:Baseline, 6 months
2 BP measures were taken 1 minute apart using a LifeSource UA-789 digital blood pressure monitor.
Baseline, 6 months
Change in Low-Density Lipoprotein (LDL) Cholesterol
時間枠:Baseline, 6 months
Finger stick, spectrophotometer to measure cholesterol level.
Baseline, 6 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Quality of Life as Assessed With the Short Form 12- Mental Component
時間枠:Baseline, 6 months
Short Form-12 Mental Component and Physical Component Summary scores range from 0-100; higher scores indicate greater quality of life.
Baseline, 6 months
Change in Quality of Life as Assessed With the Short Form-12- Physical Component
時間枠:Baseline, 6 months
Short Form-12 Mental Component and Physical Component Summary scores range from 0-100; higher scores indicate greater quality of life.
Baseline, 6 months
Change in Medication Use Self-efficacy Score as Measured by SEAMS Scale and the Perceived Diabetes Self-Management Scale, Which is Associated With A1c
時間枠:Baseline, 6 months
Medication use self-efficacy scores for range from 13-39; higher scores indicate higher levels of self-efficacy for medication adherence.
Baseline, 6 months
Change in Diabetes-Specific Quality of Life
時間枠:Baseline, 6 months
Diabetes specific quality of life will be assessed using the validated Diabetes Distress Scale.The DDS is a 17-item instrument that measures diabetes-related emotional distress. Participants rate the degree to which each item is problematic for them on a 6-point Likert scale, from 1 (no problem) to 6 (serious problem). A score of 3 or greater = moderate distress.
Baseline, 6 months
Number of Physician Office Visits 6 Months
時間枠:6 months
6 months
Number of Hospital Stays at 6 Months
時間枠:6 months
6 months
Number of Emergency Visits at 6 Months
時間枠:6 months
6 months
Change in Diabetes Medication Counts
時間枠:Baseline, 6 months
Change in number of diabetes medications.
Baseline, 6 months

その他の成果指標

結果測定
メジャーの説明
時間枠
Change in Medication Beliefs- Harm (Beliefs That Medications Are Harmful)
時間枠:Baseline, 6 months
Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs.
Baseline, 6 months
Change in Medication Beliefs- Overuse (Concerns About the Way Doctors Use Medications)
時間枠:Baseline, 6 months
Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs.
Baseline, 6 months
Change in Medication Beliefs-Necessity (Beliefs About the Necessity of Medications)
時間枠:Baseline, 6 months
Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs.
Baseline, 6 months
Change in Medication Beliefs- Concerns (Concerns About the Negative Effects of Medications)
時間枠:Baseline, 6 months
Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs.
Baseline, 6 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:Monika M Safford, MD、Weill Medical College of Cornell University

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4月1日

一次修了 (実際)

2019年1月31日

研究の完了 (実際)

2019年1月31日

試験登録日

最初に提出

2014年10月14日

QC基準を満たした最初の提出物

2014年10月22日

最初の投稿 (見積もり)

2014年10月24日

学習記録の更新

投稿された最後の更新 (実際)

2020年10月29日

QC基準を満たした最後の更新が送信されました

2020年10月6日

最終確認日

2020年10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

  • PCORI-R-AD-1306-03565

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

IPD プランの説明

Data will stay at UAB

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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