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Идёт набор NCT06319885

Text Messaging to Reduce High-risk Alcohol Use Among Older Adults

Без фазы С лечением Hazardous Alcohol Use

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: Text messaging.
Кому может быть актуально
Состояния в реестре: Hazardous Alcohol Use. Базовые параметры: 55 лет — 80 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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Обзор

High-risk drinking is very prevalent among Danes aged 55+. It poses a serious risk to health and independent living, burdening health care systems and family members. Measures to reduce high-risk alcohol use in this growing group at need are urgently needed. A recent small study from the US shows that text messaging reduces high-risk alcohol intake in older adults. The investigators will conduct a pilot study with the same intervention in Denmark, with adaptations to language and culture. The pilot study will investigate among Danish older adults whether text messaging is well-accepted by participants and feasible in terms of reducing 1) high-risk drinking and 2) commonly accompanying problems with daily functioning, social relationships, and mental and physical health. The pilot-trial will include n=60 adults aged 55-80 years who will receive alcohol-related text messages (within a secure app for data protection purposes) over 12 weeks. Assessments will include a baseline assessment and a post-assessment.

Вмешательства

  • Поведенческое Text messaging
    Participants receive text messages related to their alcohol consumption.

Первичные конечные точки

  • High-risk alcohol use (yes/no) [Срок оценки: Assessed at 12 weeks after baseline, alcohol use through the past seven days]
Вторичные конечные точки (8)
  • WHOQOL-Bref (The World Health Organization Quality of Life Brief Version ) [Срок оценки: Assessed at 12 weeks after baseline]
  • OBSESSIVE-COMPULSIVE DRINKING SCALE (OCDS) [Срок оценки: Through the past seven days, assessed at 12 weeks after baseline]
  • Drinker Inventory of Consequences (DrInC-2R) [Срок оценки: Through the past 14 days, assessed at 12 weeks after baseline]
  • Frequency of alcohol use [Срок оценки: Assessed at 12 weeks after baseline, alcohol use through the past seven days]
  • Amount of alcohol use [Срок оценки: Assessed at 12 weeks after baseline, alcohol use through the past seven days]
  • Heavy drinking days [Срок оценки: Assessed at 12 weeks after baseline, alcohol use through the past seven days]
  • User evaluation (tailor-made) [Срок оценки: Assessed at 12 weeks after baseline, through 12 weeks (the intervention period)]
  • PHQ-9 (Patient Health Questionnaire-9 ) [Срок оценки: Assessed at 12 weeks after baseline, through the past 14 days]

Критерии участия

Критерии включения

  • consumption of > 10 standard drinks á 12 gram ethanol per week (i.e., high-risk alcohol use defined by the Danish Health Authority) in the past four weeks
  • desire to reduce drinking
  • age 55 to 80 years
  • mobile phone ownership and willingness to receive and respond to text messages
  • fluency in Danish.

Критерии исключения

  • drinking more than 53 standard drinks per week in the last four weeks
  • past 12 month alcohol withdrawal symptoms or lifetime history of serious withdrawal symptoms (e.g., seizures)
  • score above 12 on the Short alcohol withdrawal scale; SAWS
  • possible drug dependence (i.e., use of illegal drugs or psychotropic medication taken without prescription more than once a month)
  • indication of serious psychiatric illness (lifetime diagnosis of psychosis or bipolar disorder, inpatient treatment or medication for these, recent suicidality)
  • current alcohol/drug abuse treatment or a desire to start alcohol/drug abuse treatment during the study
  • medical condition that requires abstinence from alcohol
  • wish to achieve abstinence (applied to secure a focus on reduction)
  • lack of understanding of study protocol or reading difficulty as evidenced by a score of less than 7 out of 10 on the consent form quiz.

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
  • University of Southern Denmark, Department of Psychology — Odense

Идентификаторы

NCT: NCT06319885 · SDU project nr. 3110386 · ID: 158341

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗