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Идёт набор NCT06887049

Achieving Routine Intervention and Screening for Emotional Health

Без фазы С лечением Type 2 Diabetes Mellitus (T2DM) Diabetes Distress

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: ARISE Learning Community Diabetes Distress Screening and Intervention, ARISE Enhanced Care brief training.
Кому может быть актуально
Состояния в реестре: Type 2 Diabetes Mellitus (T2DM), Diabetes Distress. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

ARISE: Achieving Routine Intervention and Screening for Emotional Health: Randomized Controlled Trial

Обзор

The purpose of this project is to evaluate the effectiveness of diabetes distress screening and intervention on patients with type 2 diabetes mellitus (T2DM).

Подробное описание

Diabetes mellitus (DM) affects 30 million people in the U.S.1 The prevalence of diabetes is higher among Hispanics (12.5%) and African Americans (11.7%) compared to non-Hispanic whites (7.5%). Managing type 2 DM (T2DM) can be complex and burdensome; patients must modify their diet and exercise habits, take medications, check their blood sugars, visits their healthcare providers regularly, and navigate work and family life. Financial insecurity and social risks (e.g., transportation access) also disproportionately affect persons of color in the U.S. and in turn impede patients' ability to adhere to diabetes self-care recommendations. Diabetes distress (DD) is the stress, fear, and guilt in having to manage diabetes and is distinct from depression and anxiety. A meta-analysis of 58 international studies noted one in five adults with diabetes had elevated DD.6 DD has well documented associations with poor medication adherence, dietary and exercise behaviors, quality of life, and glycosylated hemoglobin (A1C). African-Americans and Hispanics have higher levels of DD compared to non-Hispanic whites.

The American Diabetes Association published guidelines promoting screening for and addressing DD as a critical part of clinical care. Multiple studies have tested standardized screening instruments for DD and intervention studies have demonstrated reductions in DD. However, only 24% of adults with diabetes report their health care team asked them how diabetes affected their lives and far fewer currently receive structured DD screening and follow-up. Efforts to systematically identify and address DD could be an important strategy to improve diabetes outcomes and address diabetes disparities. Community health centers (CHCs) can be important partners in this effort. CHCs provide primary care for 2.5 million adults with diabetes, of whom 30% have A1C \>9% and 57% are racial ethnic minorities.

No studies have systematically implemented DD screening and treatment interventions into a real-world primary care setting or used a guideline based approach. To fill this gap, we developed the ARISE (Achieving Routine Intervention and Screening for Emotional health) intervention. ARISE is a primary care training and implementation program for clinicians and allied health professionals to support screening for and address DD in T2DM. ARISE utilizes a standardized process for screening adult patients with T2DM for DD using validated instruments, provides training and support for CHC staff applying evidence-based strategies on how to address DD in the encounter, and an algorithm for action steps and referrals based on individualized sources of DD (e.g. hypoglycemia, access based on social needs). This pragmatic study will compare ARISE to enhanced usual care (didactic lecture for clinical staff on emotional health of persons with diabetes) using a type I hybrid effectiveness-implementation design via a cluster randomized controlled trial. This study provides the opportunity to optimize T2DM care for populations with health disparities concordant with evidence-based guidelines to aid in the attainment of optimal glycemic control.

Вмешательства

  • Поведенческое ARISE Learning Community Diabetes Distress Screening and Intervention
    In-depth training for frontline community health center staff on ARISE algorithm to screen for degree of diabetes distress using T2-DDAS Core. If positive, screen for sources of diabetes distress using T2-DDAS Sources. Discuss results with patient and make any relevant referrals.
  • Поведенческое ARISE Enhanced Care brief training
    Brief training on American Diabetes Association guidelines for screening for diabetes distress using the 7A's model

Первичные конечные точки

  • Rate of A1C across time [Срок оценки: 12 months]
Вторичные конечные точки (7)
  • Average diabetes distress score [Срок оценки: 12 months]
  • Average of low density lipoproteins (LDL Cholesterol) measure [Срок оценки: 12 months]
  • Average systolic blood pressure across time [Срок оценки: 12 months]
  • Average Body mass index at baseline and follow-up [Срок оценки: 12 months]
  • Average depression screening (PHQ) [Срок оценки: 12 months]
  • Average score of anxiety screening (GAD) [Срок оценки: 12 months]
  • Average number of referrals across patients over time [Срок оценки: 12 months]

Критерии участия

Критерии включения

  • Patient at a participating clinic
  • Type 2 diabetes
  • Adult (18 years or older)
  • A1C > 8%

Критерии исключения

  • Pregnant

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

США · 1 центр
  • University of Chicago — Chicago

Публикации

  • Fisher L, Polonsky WH, Hessler D. Addressing diabetes distress in clinical care: a practical guide. Diabet Med. 2019 Jul;36(7):803-812. doi: 10.1111/dme.13967. Epub 2019 May 7. PMID 30985025
  • Chew BH, Vos RC, Metzendorf MI, Scholten RJ, Rutten GE. Psychological interventions for diabetes-related distress in adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2017 Sep 27;9(9):CD011469. doi: 10.1002/14651858.CD011469.pub2. PMID 28954185
  • Shin, P., Sharac, J., Barber, Z., Rosenbaum, S., & Paradise, J. (2015, March). Community Health Centers: A 2013 Profile and Prospects as ACA Implementation Proceeds. The Henry J. Kaiser Family Foundation. Retrieved from http://kff.org/medicaid/issue-brief/community-health-centers-a-2013-profileand-prospects-as-aca-implementation-proceeds/
  • Health Resources and Services Administration (HRSA). Health Center Program. Table 7. Health Outcomes and Disparities. National Data. Available at: https://data.hrsa.gov/tools/datareporting/program-data/national/table?tableName=7&year=2020.
  • Schmidt CB, van Loon BJP, Vergouwen ACM, Snoek FJ, Honig A. Systematic review and meta-analysis of psychological interventions in people with diabetes and elevated diabetes-distress. Diabet Med. 2018 Jun 13. doi: 10.1111/dme.13709. Online ahead of print. PMID 29896760
  • Wagner H, Pizzimenti JJ, Daniel K, Pandya N, Hardigan PC. Eye on diabetes: a multidisciplinary patient education intervention. Diabetes Educ. 2008 Jan-Feb;34(1):84-9. doi: 10.1177/0145721707312205. PMID 18267994
  • Nicolucci A, Kovacs Burns K, Holt RI, Comaschi M, Hermanns N, Ishii H, Kokoszka A, Pouwer F, Skovlund SE, Stuckey H, Tarkun I, Vallis M, Wens J, Peyrot M; DAWN2 Study Group. Diabetes Attitudes, Wishes and Needs second study (DAWN2): cross-national benchmarking of diabetes-related psychosocial outcomes for people with diabetes. Diabet Med. 2013 Jul;30(7):767-77. doi: 10.1111/dme.12245. PMID 23711019
  • Fisher L, Hessler D, Glasgow RE, Arean PA, Masharani U, Naranjo D, Strycker LA. REDEEM: a pragmatic trial to reduce diabetes distress. Diabetes Care. 2013 Sep;36(9):2551-8. doi: 10.2337/dc12-2493. Epub 2013 Jun 4. PMID 23735726

Идентификаторы

NCT: NCT06887049 · IRB24-0622 · R01DK133603-02

Первоисточники (государственные реестры)

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