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Идёт набор NCT06003634

OASIS: Peer Support for T2DM in Appalachia (Peer Coaches)

Без фазы С лечением Diabetes Mellitus, Type 2

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: Peer Coaching - Peer Participants A, Peer Coaching - Peer Participants B, Peer Coaching - Peer Participants C, Peer Coaching - Peer Participants D.
Кому может быть актуально
Состояния в реестре: Diabetes Mellitus, Type 2. Базовые параметры: от 55 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

Older Adults Using Social Support to Improve Self-Care: Adaptation, Implementation, and Feasibility of Peer Support for Older Adults With T2DM in Appalachia.

Обзор

The goal of this clinical trial is to compare the effects of peer coaching models in older adults with unmanaged type two diabetes. The main questions it aims to answer are: * Are peer coaching models effective at promoting Type 2 Diabetes Mellitus self-management? * If effective, which facets of the peer model are most effective? Peer coaches will undergo peer coach training. * Reach out to peer participants on a weekly/biweekly time frame to discuss self-management and goal setting. * Retain records of contact, topics discussed, and general notes on interactions. Researchers will compare differences in the frequency of contact, as well as how peer coaches were matched to peer participants to see if efficacy of the intervention is altered between groups.

Подробное описание

The Older Adults using Social Support to Improve Self-Care (OASIS) intervention is an asset-based approach, utilizing the unique social structure existing in Kentucky's rural Appalachian communities to address self-care behaviors as they relate to Type 2 Diabetes Mellitus (T2DM) management. The intervention will be composed of two groups: peer coaches who have managed T2DM (HbA1c \< 7.5%), and peer participants who have unmanaged T2DM (HbA1c ≥ 7.5%). Peer coaches will undergo training prior to intervention initiation to develop coaching skills. Peer participants will be linked to a peer coach in one of four ways: (1) self-select coach with contact once a week (2) self-selected coach with contact every 2 weeks (3) matched with peer coach with contact once a week (4) matched with peer coach with contact every 2 weeks. In addition to evaluating the effectiveness of a peer coaching model, the four groups will be evaluated allowing for a more detailed understanding of factors that influence self-care behaviors. Stakeholders will also be engaged at three time points: prior to the intervention, study mid-point, and at study conclusion. At study conclusion, a small cohort of both peer participants and peer coaches will be invited to contribute to stakeholder group interviews. Information exchange with stakeholders will aid in developing a robust understanding of influential factors and how to effectively promulgate the intervention.

Вмешательства

  • Поведенческое Peer Coaching - Peer Participants A
    Peer participants in group A will be contacted by peer coaches on a weekly basis.
  • Поведенческое Peer Coaching - Peer Participants B
    Peer participants in group B will be contacted by peer coaches on a bi-weekly basis.
  • Поведенческое Peer Coaching - Peer Participants C
    Peer participants in group C will be contacted by peer coaches on a weekly basis.
  • Поведенческое Peer Coaching - Peer Participants D
    Peer participants in group D will be contacted by peer coaches on a bi-weekly basis.

Первичные конечные точки

  • Number of Participants with Change in A1c [Срок оценки: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.]
Вторичные конечные точки (12)
  • Diabetes Empowerment [Срок оценки: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.]
  • Quality of Life Index [Срок оценки: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.]
  • Social Support [Срок оценки: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.]
  • Depression Scale [Срок оценки: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.]
  • Problem Areas in Diabetes [Срок оценки: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.]
  • Diabetes Self-Management [Срок оценки: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.]
  • Acts of Daily Living [Срок оценки: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.]
  • Social Network Scale [Срок оценки: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.]
  • Diabetes Knowledge Questionnaire [Срок оценки: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.]
  • Problem Solving Skills [Срок оценки: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.]
  • Brooks Medication Adherence [Срок оценки: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.]
  • Frailty [Срок оценки: Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.]

Критерии участия

Критерии включения

  • Age greater than or equal to 55 years
  • Resident in Rural Kentucky
  • Positive diagnosis of Type 2 Diabetes Mellitus
  • HbA1c less than 7.5 for peer coaches
  • Passing score on cognitive assessment administered by study personnel
  • English Speaking

Критерии исключения

  • Age less than 55 years
  • Not a resident of a Rural Kentucky County
  • No Type 2 Diabetes Mellitus Diagnosis
  • Cognitive Impairment
  • Non-English Speaking

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Факторный дизайн
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

США · 2 центра
  • Barren River Area Development District — Bowling Green
  • UK HealthCare — Hazard

Публикации

  • Smalls BL, Kruse-Diehr A, Ortz CL, Douthitt K, McLouth C, Shelton R, Taylor Z, Williams E. Older adults using social support to improve self-care (OASIS): Adaptation, implementation and feasibility of peer support for older adults with T2D in appalachia: A feasibility study protocol. PLoS One. 2024 Mar 18;19(3):e0300196. doi: 10.1371/journal.pone.0300196. eCollection 2024. PMID 38498512

Идентификаторы

NCT: NCT06003634 · 25-0304 · R01DK135885-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗