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临床试验/NCT06319885
NCT06319885招募中不适用

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

University of Southern Denmark1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年4月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
High-risk alcohol use (yes/no)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

Participants are informed in the study material that they are allocated to groups that receive different text messages. They receive no further information on the intervention groups.

入排标准

年龄范围
55 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Gain-framed

Experimental

One daily text-message and weekly alcohol use assessment. The text-messages focus on the positive consequences of drinking less.

干预措施: Text messaging (Behavioral)

Loss-framed

Experimental

One daily text-message and weekly alcohol use assessment. The text-messages focus on the negative consequences of a high alcohol-intake.

干预措施: Text messaging (Behavioral)

Static-tailored

Experimental

One daily text-message and weekly alcohol use assessment. The text-messages are adapted to the participant's gender and to baseline information on (e.g.) participants' drinking patterns, social network, and self-efficacy. One message per week is adapted to the day on which the participants find it most challenging to reduce their drinking.

干预措施: Text messaging (Behavioral)

Adaptive-tailored

Experimental

One daily text-message and weekly alcohol use assessment. The text-messages are adapted to the participant's gender and to baseline information on (e.g.) participants' drinking patterns, social network, and self-efficacy. One message per week is adapted to the day on which the participants find it most challenging to reduce their drinking. In addition, text messages are adapted to the weekly alcohol-assessment over time and participants can demand supportive Just-In-Time messages.

干预措施: Text messaging (Behavioral)

Combined

Experimental

This arm combines all features of the arms Adaptive-tailored and Gain-framed.

干预措施: Text messaging (Behavioral)

Assessment-only

No Intervention

The control group. Participants do only receive 4 questions on their alcohol intake once a week.

结局指标

主要结局

High-risk alcohol use (yes/no)

时间窗: Assessed at 12 weeks after baseline, alcohol use through the past seven days

Drinking over 120 gram ethanol in seven days (determined by outcomes 4 \& 5 )

次要结局

  • PHQ-9 (Patient Health Questionnaire-9 )(Assessed at 12 weeks after baseline, through the past 14 days)
  • WHOQOL-Bref (The World Health Organization Quality of Life Brief Version )(Assessed at 12 weeks after baseline)
  • OBSESSIVE-COMPULSIVE DRINKING SCALE (OCDS)(Through the past seven days, assessed at 12 weeks after baseline)
  • Amount of alcohol use(Assessed at 12 weeks after baseline, alcohol use through the past seven days)
  • Heavy drinking days(Assessed at 12 weeks after baseline, alcohol use through the past seven days)
  • Drinker Inventory of Consequences (DrInC-2R)(Through the past 14 days, assessed at 12 weeks after baseline)
  • Frequency of alcohol use(Assessed at 12 weeks after baseline, alcohol use through the past seven days)
  • User evaluation (tailor-made)(Assessed at 12 weeks after baseline, through 12 weeks (the intervention period))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Silke Behrendt

Professor

University of Southern Denmark

研究点 (1)

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