Effectiveness of Nurse-Conducted Brief Intervention supplemented with Mobile-based Application for Monitoring and Relapse Prevention in Patients with Alcohol Use Disorders: A Randomized Controlled Trial.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Primary Outcome:Relapse (Lapse, Relapse, Abstinence)
研究概览
简要总结
The primary purpose of the protocol is to investigate the effectiveness of a Nurse-Conducted Brief Intervention (NCBI) supplemented with a Smart Mobile Health Application in monitoring and preventing relapse among patients with Alcohol Use Disorders (AUDs) within a Tertiary Care Center. The study aims to address the need for effective interventions to prevent relapse and support patients in overcoming alcohol addiction. Additionally, it seeks to bridge the gap between traditional care and clinical need by utilizing modern technology for continuous communication, monitoring, and relapse prevention strategies.
The study’s primary objective is to determine the effectiveness of the combined approach of NCBI and a Mobile Health Application in monitoring and preventing relapse for a three-month period, compared to using only Nurse-Conducted Brief Intervention, in patients with AUDs within a Tertiary Care Center.
The hypotheses to be tested are as follows:
Null Hypotheses (H0): There is no significant difference in relapse rates between the group receiving Nurse-Conducted Brief Intervention (NCBI) supplemented with the Mobile Health Application and the group receiving only Nurse-Conducted Brief Intervention (NCBI).
Alternative Hypotheses (Ha): There is a significant difference in relapse rates between the group receiving Nurse-Conducted Brief Intervention (NCBI) supplemented with the Mobile Health Application and the group receiving only Nurse-Conducted Brief Intervention (NCBI).
These hypotheses frame the main comparison between the two groups in terms of their relapse rates, which is the primary outcome measure of the study. The study is motivated by the high morbidity and mortality associated with AUDs, and despite available treatments, relapse rates remain a challenge. The existing literature supports the effectiveness of brief psychological interventions like NCBI in managing harmful drinking, but there is a need to enhance these interventions, particularly in terms of relapse prevention. Mobile health technology, including smartphone applications, has shown potential in providing consistent support for individuals with AUDs, but its integration with traditional interventions like NCBI needs exploration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 59.00 Year(s)（—）
- 性别
- Male
入选标准
- •Participants must be male, aged 18-59, diagnosed with alcohol dependence based on ICD-10 criteria to be eligible for the study, with an android smartphone.
排除标准
- •Excluded from the study are females, individual below 18 or above 59, those with severe medical conditions, psychiatric disorders hindering participation, and those unable to provide consent.
结局指标
主要结局
Primary Outcome:Relapse (Lapse, Relapse, Abstinence)
时间窗: Time point of Primary Interest: One month and Three months post-intervention
Metric: Percentage of participants experiencing relapse, lapse, or maintaining abstinence
时间窗: Time point of Primary Interest: One month and Three months post-intervention
次要结局
- Secondary Outcomes: 1. Sociodemographic Factors: Metric: Collected using BIG proforma. 2. Severity of Alcohol Dependence: Severity of Alcohol Dependence Metric: Scored using the Severity of Alcohol Dependence Questionnaire (SADQ)3. Motivation to Reduce/Quit Alcohol: Motivation to abstain from alcohol Metric: Scored using the Readiness to Change Questionnaire. 4. Alcohol Use Disorders Identification: Alcohol Use Disorders Identification Metric: Scored using the Alcohol Use Disorders Identification Test (AUDIT)(Time point of interest: Baseline, one month,Three months post-intervention)
研究者
Alvin Joseph
St. John’s Medical College and Hospital, Sarjapur Road, Bangalore