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Набор скоро начнётся NCT07482150

The Connect Trial: Connecting Hospital Patients to Alcohol Care

Без фазы С лечением Alcohol Use Disorder

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: AUD treatment sessions with an outreach alcohol therapist at the hospital, Guidance and leaflet on AUD treatment facilities outside the hospital.
Кому может быть актуально
Состояния в реестре: Alcohol Use Disorder. Базовые параметры: 18 лет — 99 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
Дания
Следующий шаг
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Официальное название

The Connect Trial: Connecting Hospital Patients to Alcohol Care - a Randomized Controlled Feasibility Trial

Обзор

The main objective of this pilot study is to assess feasibility of conducting a definitive RCT with concealed allocation, blinded outcome assessment and a 1:1 parallel group design of A) an invitation to meet an AUD therapist for up to 10 treatment sessions at the hospital in up to 6 months (intervention) compared to B) guidance on how to seek alcohol care in an AUD treatment centre in the community, outside of the hospital (control).

Вмешательства

  • Другое AUD treatment sessions with an outreach alcohol therapist at the hospital
    Participants will be offered an AUD treatment session at the hospital the same or next day as they are enrolled in the study with an outreach alcohol therapist from a local AUD treatment facility. The alcohol therapist will be trained in motivational interviewing and cognitive behavioural therapy for AUD. The session will aim to motivate patients to reduce their alcohol consumption and set goals for AUD treatment. The alcohol therapist can recommend a medical therapy to support alcohol reduction
  • Другое Guidance and leaflet on AUD treatment facilities outside the hospital
    Participants randomised as controls will be offered a leaflet informing about different possibilities for alcohol misuse treatments and guidance on how to approach them (may include referral or help with doing an appointment, if possible according to the specific treatment center) in the catchment area of SUH Køge and Roskilde

Первичные конечные точки

  • Recruitment [Срок оценки: 6 months]
  • Retention [Срок оценки: 6 months]
  • Completion [Срок оценки: 6 months]
Вторичные конечные точки (12)
  • AUD treatment engagement after 6 and 12 months [Срок оценки: 12 months]
  • Mortality after 6 and 12 months [Срок оценки: 12 months]
  • Change in drinks (containing 12 g ethanol) per last 30 days from baseline till 6 months after inclusion [Срок оценки: 6 months]
  • Proportion with abstinence or light drinking (<10 drinks/week) last 30 days [Срок оценки: 6 months]
  • Change in blood phosphatidyl ethanol level from baseline to 6 months after inclusion [Срок оценки: 6 months]
  • Change in motivation to cut down on alcohol (yes or no), calculated as the difference between baseline and 6 months follow-up [Срок оценки: 6 months]
  • Number of AUD treatment sessions [Срок оценки: 6 months]
  • Proportion initiating medical AUD therapy [Срок оценки: 6 months]
  • Proportion receiving medical AUD treatment at 6- and 12 months follow up [Срок оценки: 12 months]
  • Number of acute hospital admissions or emergency room visits at 6 and 12 months [Срок оценки: 12 months]
  • Number of hospital outpatient visits at 6 and 12 months [Срок оценки: 12 months]
  • 3- year follow-up, conducted through health care registries and AUD treatment facilities to look for incidence of alcohol-related morbidity and mortality, visits to general practitioner and hospital contacts [Срок оценки: 3 years]

Критерии участия

Критерии включения

  • Hospitalised or seen in an outpatient clinic at SUH Køge
  • Full-filling international classification of disease version 10: F102: alcohol dependence or F101: harmful alcohol use
  • Informed written consent
  • Being able to meet the AUD therapist in connection with a hospital visit with a health condition wholly or partly attributable to alcohol

Критерии исключения

  • Ongoing specialized treatment for AUD
  • Not speaking Danish
  • Not living in the catchment area of Zealand University hospital
  • Age < 18 years
  • Enrolled in the Zealand alcohol-related liver disease cohort study

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
Простое слепое
Основная цель
Профилактика

Центры проведения

Дания · 1 центр
  • Zealand University Hospital, Department of Medicine — Køge

Публикации

  • Schwarz AS, Nielsen B, Sogaard J, Sogaard Nielsen A. Making a bridge between general hospital and specialised community-based treatment for alcohol use disorder-A pragmatic randomised controlled trial. Drug Alcohol Depend. 2019 Mar 1;196:51-56. doi: 10.1016/j.drugalcdep.2018.12.017. Epub 2019 Jan 17. PMID 30665152
  • Incze MA, Kelley AT, James H, Nolan S, Stofko A, Fordham C, Gordon AJ. Post-hospitalization Care Transition Strategies for Patients with Substance Use Disorders: A Narrative Review and Taxonomy. J Gen Intern Med. 2024 Apr;39(5):837-846. doi: 10.1007/s11606-024-08670-5. Epub 2024 Feb 27. PMID 38413539

Идентификаторы

NCT: NCT07482150 · SJ-1130

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗