Medical Care, Education, Social Support, And Goal-setting to Empower Self-management for Diabetes (MESSAGES)
2022年11月1日 更新者：University of Chicago
Diabetes MESSAGES (Medical Care, Education, Social Support, And Goal-setting to Empower Self-management): Implementing Diabetes Group Visits and Text Messaging in Community Health Centers
Diabetes group visits, shared appointments where patients receive self-management education in a group setting and have a medical visit, are a promising way to deliver high quality diabetes care.
Group visits can improve glycemic control and decrease healthcare utilization.
To date, no studies have systematically implemented a diabetes group visit intervention in a network of U.S. community health centers.
The University of Chicago is partnering with Midwest Clinicians' Network (MWCN), a member organization of 130 health centers across ten Midwestern states.
Approximately half of all Federally Qualified Health Centers in this region are affiliated with MWCN.
The objectives of the study are [1] providers and staff at 20 health centers will have the requisite knowledge, skills, and motivation to implement a diabetes group visit plus text messaging intervention at their sites; [2] changes in diabetes processes of care; knowledge, attitudes, and skills for diabetes self-management; clinical outcomes; and health care utilization for patients participating in the diabetes group visit program will be evaluated; and [3] the diabetes group visit program will be available for dissemination among and use by health centers and healthcare providers at the local, state, regional, and national levels.
調査の概要
詳細な説明
UChicago and MWCN will recruit and enroll 20 health centers (HCs) to participate in a training intervention and to implement diabetes group visit and text messaging programs at their clinic sites.
Each HC will assemble a team of 3-4 providers and staff to participate in the training.
HCs will be randomized to one of two training cohorts.
HC providers and staff will attend two in-person Learning Sessions in Chicago and a series of monthly webinars, recruit and enroll patients, implement a 6-month diabetes group visit and text messaging program plus subsequent booster sessions, complete periodic surveys and interviews, assist with data collection through patient surveys and chart abstraction, and present their program to peer HCs during Learning Sessions and to local stakeholders, state primary care organizations, or other professional groups.
Each HC will enroll 15 patients in the group visit and text messaging program; the 2018 Training Cohort will do so immediately following their enrollment in the study and the 2020 Training Cohort will do so after 18 months.
During the first 18 months, the 2020 Training Cohort will collect data from electronic health records (EHR) of randomly selected patients to serve as a control group.
Changes in self-reported outcomes, diabetes processes of care, and clinical outcomes will be assessed for intervention patients from baseline through 2 year follow up, and processes of care and clinical outcomes will be compared for intervention vs. control participants.
Capacity of HC providers and staff to conduct a group visit and text messaging intervention for patients with diabetes, as well as their confidence in identifying and addressing health disparities, will be evaluated through surveys and in-depth interviews.
This study will expand knowledge of the barriers, facilitators, and perceived benefits and drawbacks of group visit and text messaging interventions and inform the development of a toolkit that will be disseminated to other HCs.
研究の種類
介入
入学 (実際)
265
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
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Illinois
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Chicago、Illinois、アメリカ、60637
- University of Chicago
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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
18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:
- 18 years or older
- diagnosis of type 2 diabetes
- attended at least two appointments at the HC within the past year, with at least one of them being during the past six months
- last documented A1c result greater than or equal to 8.0% (test must have been done during the last 6 months)
- own a cellular phone with text messaging capabilities
- have the ability to read and send text messages
- English or Spanish speaking
Exclusion Criteria:
- pregnant or planning to become pregnant
- uncontrolled psychiatric problem
- dementia or other cognitive impairment
- hearing difficulties or severe physical disability that would prevent them from participation in group visit
- planning to relocate in the next year or leave the area during the group visit period
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：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：2018 Training Cohort
10 health centers will be randomized to the 2018 Training Cohort.
Teams from these health centers will be trained and will implement a 6 month diabetes group visit and text messaging intervention (Diabetes MESSAGES Program).
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Health centers in the 2018 Training Cohort will enroll groups of 10-15 patients to attend 6 monthly diabetes group visits consisting of group education, social support, goal setting, and an individual medical visit for each patient.
At the same time, patients will be enrolled in a 6-month interactive diabetes text messaging program.
Patients will receive quarterly booster sessions for 1-2 years after the 6-month intervention period.
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他の：2020 Training Cohort
10 health centers will be randomized to the 2020 Training Cohort.
Prior to beginning training, these health centers will collect data on randomly selected patients receiving usual care to serve as the control group.
After this first parallel group trial period, teams from these health centers will be trained and will implement the 6 month diabetes group visit and text messaging intervention during a second single group trial period (Diabetes MESSAGES Program (second trial)).
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During the first trial period, health centers in the 2020 Training Cohort will collect data on patients receiving usual care.
After the first trial period, health centers in the 2020 Training Cohort will enroll groups of 10-15 patients to attend 6 monthly diabetes group visits consisting of group education, social support, goal setting, and an individual medical visit for each patient.
At the same time, patients will be enrolled in a 6-month interactive diabetes text messaging program.
Patients will receive quarterly booster sessions for 1-2 years after the 6-month intervention period.
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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 |
時間枠 |
|---|---|
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Hemoglobin A1C
時間枠：change from baseline to 12 months
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change from baseline to 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 |
|---|---|---|
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Hemoglobin A1C
時間枠：baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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Blood pressure
時間枠：baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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Weight
時間枠：baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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Cholesterol
時間枠：baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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Diabetes processes of care
時間枠：baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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Receipt of recommended screenings, exams, referrals, and vaccinations
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baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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Medication management of diabetes
時間枠：baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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changes in prescribed diabetes medications for patients with inadequate diabetes control
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baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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Number of hypoglycemic events
時間枠：baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Number of hospital admissions
時間枠：baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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Number of primary care, specialist, and ER visits
時間枠：baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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Smoking status
時間枠：baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Health related quality of life (SF-12)
時間枠：baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Depression (PHQ-2)
時間枠：baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Summary of Diabetes Self-Care Activities Measure
時間枠：baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Understanding of Diabetes Self-Management (Diabetes Care Profile)
時間枠：baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Attitudes Towards Diabetes (Diabetes Care Profile)
時間枠：baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Diabetes Distress Scale (DDS-2)
時間枠：baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Diabetes Quality of Life Scale
時間枠：baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Diabetes Self-Empowerment Scale
時間枠：baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Diabetes Social Support Scale
時間枠：baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Patient satisfaction with intervention
時間枠：6 month and 12 month for intervention patients only
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6 month and 12 month for intervention patients only
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CAHPS Overall Rating
時間枠：baseline, 6 month, and 12 month for intervention patients only
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Patient satisfaction with overall care at health center
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baseline, 6 month, and 12 month for intervention patients only
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CAHPS Cultural Competency
時間枠：baseline, 6 month, and 12 month for intervention patients only
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Patient satisfaction with cultural competency of care at health center
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baseline, 6 month, and 12 month for intervention patients only
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CAHPS Provider Communication
時間枠：baseline, 6 month, and 12 month for intervention patients only
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Patient satisfaction with provider communication at health center
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baseline, 6 month, and 12 month for intervention patients only
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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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Patient engagement
時間枠：through study completion, an average of 2 years
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Attendance/participation in group visits, text messaging, and booster sessions
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through study completion, an average of 2 years
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Health center provider/staff preparedness
時間枠：change from pre- to post-training (from baseline to 1 month, 7 month, and 16 month)
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Capacity, confidence, motivation, perceived benefits and barriers
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change from pre- to post-training (from baseline to 1 month, 7 month, and 16 month)
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Health center provider/staff satisfaction
時間枠：post-training (16 month)
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Satisfaction with training, group visits, and text messaging
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post-training (16 month)
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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。
スポンサー
捜査官
- 主任研究者：Arshiya Baig, MD, MPH、University of Chicago
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)
2018年10月18日
一次修了 (実際)
2022年5月15日
研究の完了 (実際)
2022年6月30日
試験登録日
最初に提出
2018年3月21日
QC基準を満たした最初の提出物
2018年3月27日
最初の投稿 (実際)
2018年4月4日
学習記録の更新
投稿された最後の更新 (実際)
2022年11月3日
QC基準を満たした最後の更新が送信されました
2022年11月1日
最終確認日
2022年11月1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。
2型糖尿病の臨床試験
Diabetes MESSAGES Programの臨床試験
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Texas Scottish Rite Hospital for Childrenまだ募集していません
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Vanderbilt University Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Institutes...完了
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Children's Health完了
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Centre Hospitalier Universitaire de la Réunion募集
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Helse Nord-Trøndelag HFNorwegian University of Science and Technology完了
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AdventHealthState of Florida Department of Health募集