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临床试验/NCT03402256
NCT03402256已完成不适用

Text Messaging to Reduce Alcohol Relapse in Liver Transplant Patients

Yale University2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2013年3月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
Intervention Feasibility Evaluation

研究概览

简要总结

This is a research study of a text-messaging intervention to reduce alcohol relapse risk in pre-transplant liver transplantation patients. This study is an 8-week, randomized controlled pilot trial to investigate the feasibility and acceptability of a text-messaging intervention for alcohol relapse prevention and stress reduction in 20 liver transplant patients with alcohol-related liver disease. The goals of the study are (1) to develop a mobile, SMS-based stress reduction and alcohol use intervention for pre- liver transplant patients with alcohol-related liver disease (ALD) and (2) to evaluate the feasibility and acceptability of the mobile intervention and its effect on rates of alcohol consumption compared to a Standard Care condition in a liver transplantation center.

详细描述

This study is an 8-week, randomized controlled pilot trial to investigate the feasibility and acceptability of a text-messaging intervention for alcohol relapse prevention and stress reduction in 20 liver transplant patients with alcohol-related liver disease. The scientific aims of the study are as follows:

  1. To develop a mobile, SMS-based stress reduction and alcohol use intervention for pre- liver transplant patients with alcohol-related liver disease (ALD).
  2. Evaluate the feasibility and acceptability of the mobile intervention and its effect on rates of alcohol consumption compared to a Standard Care condition in a liver transplantation center.

Text messaging is a novel mechanism for intervention in this population. Over the course of the study, participants randomized to the Text Message condition will receive messages targeting known predictors of alcohol abstinence and relapse, including (1) craving, (2) identification of high-risk situations, (3) identification of triggers, (4) stress level, (5) coping skills, and (5) quality of life. Because mobile interventions have not been utilized in studies of alcohol abstinence, the protocol for this text message intervention on past studies that have used text messages interventions. Specifically, portions of a large-scale RCT of a text message intervention for smoking cessation and of a smaller study on a text message intervention for reducing alcohol-related consequences in college students. The text messages will include motivational messages and behavior-change techniques (e.g. coping with cravings and urges to drink, trigger identification, high-risk situation identification). Messages will encourage participants to continue with sobriety and focus on the success they have achieved so far. After the first 4 weeks, they will receive 3 messages per week for the next 4 weeks. All text messages will be developed with the input of liver transplant professionals.

All patients will be assessed at 4-weeks and 8-weeks and will provide urine for EtG analysis to allow biological verification of sobriety. After the 8-week intervention, patients will complete a satisfaction survey about their experiences in the Text Message condition and Standard Care condition to assess intervention helpfulness, text message content, and the ease of using the text message program. These data will allow the examination of the feasibility and acceptability of the text message intervention.

This study has two phases: (1) Stage 1 - development of intervention text messages and (2) Stage 2 - pilot randomized controlled trial of Text Message intervention versus Standard Care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Care Provider)

盲法说明

All clinical members of the liver transplantation service will be blind to the results of self-report data collected during the study and to urine toxicology results. The PI and Co-I, who also serves as the Project Manager, will not be blind to participant condition. The Research Assistant will not be blind to the participant condition after delivery of the study-provided cell phone to participants randomized to the Text Message condition.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • at least 18 years of age;
  • diagnosis of alcohol-related liver disease;
  • currently in evaluation for UNOS listing as a liver transplant candidate;
  • last reported use of any alcohol within the past 1 year;
  • willingness to receive and respond to multiple text messages per day.

排除标准

  • unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, or dementia.

结局指标

主要结局

Intervention Feasibility Evaluation

时间窗: 8 weeks

Patterns of text message usage

Alcohol Abstinence Rates

时间窗: 8 Weeks

Biologically confirmed (EtG) rates of abstinence from alcohol

次要结局

  • Subjective Alcohol Abstinence Rates(8 Weeks)
  • Stress Ratings(8 Weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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