About this trial
The study is aimed to find out that combining Nurse-Conducted Brief Intervention (NCBI) with a Smart Mobile is better than Nurse-Conducted Brief Intervention (NCBI) only in preventing relapse among Alcohol Use Disorder patients. The high relapse rates among alcohol disorder patients may be benefitted by new technology using application for improved outcomes in managing and preventing alcohol addiction relapse.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male patients.
Aged between 18 and 59 years.
Diagnosis of alcohol dependence use disorder based on ICD-10 criteria.
Patients with an Android smartphone and the ability to use mobile application.
Disqualifiers
Female patients
Comorbid other substance abuse, except tobacco.
Comorbid major mental illness /physical illness.
Trial design
Parallel
Treatments tested in this trial
Nurse-Conducted Brief Intervention (NCBI). supplemented with mobile based application.
Behavioral* An interactive mobile based application will be developed with the following features to assist in monitoring and preventing relapse. * Purpose of the Mobile based application: The mobile application will be an interactive tool designed to assist in monitoring and preventing relapse of alcohol use disorder. It will provide various features to support users in their journey to sobriety, including personalized recovery plans, goal setting, progress tracking, stress and craving management tools, educational resources, daily reflection prompts, emergency assistance, personalized reminders, progress reports, and psychoeducational videos. * The Target population: 40 Male patients selected through randomized sampling, aged between 18 and 59 years, who have participated in Nurse-Conducted Brief Intervention (NCBI) for AUD in the Gastroenterology ward with diagnosis of alcohol dependence use disorder based on ICD-10 who have access to smartphone application and have the ability to use it.
Nurse-Conducted Brief Intervention (NCBI)
Behavioral* Nurse-Conducted Brief Intervention (NCBI) is a feasible and acceptable model of care for males diagnosed with Alcohol Use Disorders (AUDs) in gastroenterology settings. The study found that the Nurse-Conducted Brief Intervention (NCBI) had a positive impact on promoting abstinence in patients with AUDs, and the preliminary findings demonstrate probable good outcomes. \[21\]. * It consists of a trained Nurse delivering three individual sessions with the patient over a span of two to three days (15 to 20 mins each) during their period of admission in the ward and one session with the family members.
Treatment groups
Trial outcomes
Primary outcomes
Effectiveness of Nurse-Conducted Brief Intervention (NCBI) supplemented with a Mobile Health Application in preventing relapse among patients with Alcohol Use Disorders (AUDs
The primary endpoint of the study is the effectiveness of Nurse-Conducted Brief Intervention (NCBI) supplemented with a Mobile Health Application in preventing relapse among patients with Alcohol Use Disorders (AUDs) over a three-month period. • The primary outcome measure will be the difference in relapse rates between the group receiving NCBI with the mobile application and the group receiving only NCBI.
Secondary outcomes
Provide insight into the effectiveness and impact of the interventions: Sociodemographic
Assessment of socio-demographic factors, such as age, gender, education, and occupation, and their association with relapse.
Provide insight into the effectiveness and impact of the interventions: Severity of AUD
Evaluation of the severity of Alcohol Use Disorder using standardized assessment tools like the Severity of Alcohol Dependence Questionnaire (SADQ).A score of 31 or higher indicates "severe alcohol dependence".A score of 16 -30 indicates "moderate dependence".A score of below 16 usually indicates only a mild physical dependency. A score of 16 -30 indicates "moderate dependence"
Provide insight into the effectiveness and impact of the interventions:Lapse evaluation
Examination of the secondary outcome measures, including Lapse (occasional drinking without significant impairment), Abstinence (complete avoidance of alcohol), and Relapse (return to heavy drinking after a period of abstinence).
Provide insight into the effectiveness and impact of the interventions: comparison with sociodemographic factors
Comparison of the secondary outcome measures with socio-demographic factors and severity of AUD to understand potential predictors of relapse.
Locations
Sponsors and contacts
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University of Pittsburgh
Lead sponsor
Fogarty International Center of the National Institute of Health
Collaborator
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