Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06652802
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-16
Brief Title:
Effectiveness of Nurse-Conducted Brief Intervention NCBI Supplemented With Mobile for Preventing Alcohol Use Disorders
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness of Nurse-Conducted Brief Intervention NCBI Supplemented With Mobile-based Application for Monitoring and Relapse Prevention in Patients With Alcohol Use Disorders A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
A Meta-analysis including 34 studies showed that Brief Intervention helped in reducing the amount of alcohol consumption after a study duration of 1 year in comparison with the control group In India there have been few studies on Brief Intervention A comparison study of Brief intervention versus simple advice for Alcohol Use Disorder was conducted in North India in 2007 which showed a slight advantage for Brief intervention But the results were not showing a significant outcome and it was concluded that booster sessions were required A review of literature revealed that comprehensive recovery management systems using the capabilities of smart-phones to provide a variety of tools and services that can be tailored to individuals including in-the-moment assessments and access to peer discussion groups have the strongest theoretical base and have yielded the strongest and longest-lasting effects for management of alcohol use disorders 10 A study review revealed that smartphone application has the potential to monitor alcohol use and craving in the natural environment and deliver tailored treatment to users when they need it most A study revealed that smartphone-delivered coping strategies for alcohol cravings are effective in reducing craving cued drinking and that craving cues related to drinking environments and drinking times of day represent fruitful areas of intervention focus
JUSTIFICATION NEED FOR THE STUDY The present studies suggest that a substantial proportion of patients with alcohol use disorders relapse to alcohol during the course of treatment Efforts are required to delay and avoid such relapse and maintain abstinence by effective treatment approaches A major barrier to care is the lack of adequately skilled human resources to deliver contextually appropriate treatments Nurse-conducted Brief Intervention supplemented with mobile application-based can be a beneficial approach to prevent relapse and support patients in their journey to overcome alcohol addiction It also promotes a more continuous and connected recovery process by enabling regular communication and data sharing between the user and their counsellor
Proposed Methodology Only males will be included in the study
Including women in this study would necessitate a gender-specific analysis 5 which could complicate the primary objective of evaluating the combined intervention of Nurse-Conducted Brief Intervention NCBI and a mobile based application
To maintain the internal validity of this study and to ensure a clear focused evaluation of the intervention the investigators have chosen to initially focus on male participants
The non-availability of female patients or a smaller number of female patients according to hospital admission records diagnosed with alcohol dependence admitted to the hospital ward due to stigma will also affect the data collection process
Future studies will aim to address the effectiveness of these interventions specifically for women considering their unique needs and responses to treatment
SAMPLE SIZE and the BASIS for the same
The sample size was calculated using the Sample size calculator riskcalcorg for superiority trial with a dichotomous outcome The investigators based the analysis on the prevalence rates of 65 by a study in Bangalore with a 2-side significance level of 005 Power 1-beta of 08 Ratio of sample size unexposedexposed of 1 Probability of event in the unexposed group 06 Probability of event in the exposed group 04 margin of difference of 05 with a 10 dropout rate the sample size estimated was 74 34 in each group
Considering the drop out approximately 40 patients will be taken in each group to achieve the target recruitment
Study design A Randomized controlled trial Study site In-patient setting of Department of Gastroenterology St Johns Medical College Bangalore
Reasons for the recruitment of subjects from the Gastroenterology department
Due to the availability of Nurse Conducted Brief intervention NCBI service in Gastroenterology department by trained nurse
High prevalence of Alcohol Use Disorders AUDs among patients admitted in Gastroenterology department Patients in this unit often present with issues directly related to their alcohol use making it an ideal setting for intervention
Subjects who are not currently in withdrawal and have been deemed medically stable by the treating physician in the Gastroenterology unit will be enrolled for the study This ensures that participants are medically stable and suitable for the study
Study Period 1 year Method of sampling Randomized sampling the study design is a randomized controlled trial In this type of study participants are randomly assigned to two different groups ie STATISTICAL ANALYSIS The data will be reviewed for normality The data will be presented as parametric or non- parametric depending on the distribution The chi-squared test will be used to find the difference between categorical variables An Independent sample t test would be used to find the differences between the means of the two groups Repeated measure ANOVA will be used for the outcome measures
ETHICAL CONSIDERATION
The study will commence after IEC approval SJMC and IRB approval of protocol of the study
Confidentiality will be maintained
Participation will be voluntary Approval of the Institutional Ethics committee will be sought Permission from the Head of Department of Gastroenterology will be sought to enrol patients from the department of Gastroenterology The participants will be briefed on the study and provided with explanations on how the gathered medical data could be used Informed consent will be obtained from the patients prior to enrolling in the study
Screening
All patients with alcohol use disorder will be identified through inclusion and exclusion criteria from inpatient settings of the Gastroenterology department at SJMCH Confidentiality will be maintained
They will be assessed with the Clinical Institute Withdrawal Assessment of Alcohol Scale revised CIWA-Ar for monitoring withdrawal symptoms
CIWA-Ar score less than 8 or after 3 days of admission the patient will be screened for major psychiatric illness using Modified Mini Screen MMS
The Modified Mini Screen MMS is a generic screening measure for mood anxiety and psychotic spectrum disorders There are twenty-two questions with yesno responses It takes about fifteen minutes to complete
Baseline Assessment
The Socio-demographic details will be collected from participants using BIG proforma
Brief Intervention in Gastroenterology proforma is an initiative of the Department of Psychiatry St Johns Medical College Bangalore which includes informed consent socio-demographic details of the participants details regarding their drinking pattern LFT values 4 sessions of Brief Intervention and follow up status abstinent lapse relapse expired
The Severity of Alcohol Dependence Questionnaire SADQ will be used to assess the severity of alcohol dependence Severity of Alcohol Dependence Questionnaire SADQ is a short easy-to-complete self-administered 20-item questionnaire designed to measure severity of dependence on alcohol
Alcohol Use Disorder Identification Test questionnaire will be used to screen the patient for alcohol use disorders The Alcohol Use Disorders Identification Test AUDIT is a 10-item screening tool developed by the World Health Organization WHO to assess alcohol consumption drinking behaviours and alcohol-related problems The AUDIT has been validated across genders and in a wide range of racialethnic groups and is well suited for use in primary care settings Scores for each question range from 0-4 For questions 9 and 10 which only have three responses the scoring is 0 2 and 4 from left to right A score of 8 or more is associated with harmful or hazardous drinking
Readiness to change questionnaire will be used to assess the motivation to abstain from alcohol This questionnaire is used to assess how they are motivated to abstain from alcohol It has 12 questions and is scored from -2 to 2 -2 being strongly disagree -1disagree 0unsure 1agree 2strongly agree
The whole study is a three-time assessment which might take approximately 30- 40 minutes to assess
It will be ensured that the caregiver is not made to travel exclusively for the purpose of this study
MMS Modified Mini Screen
CIWA - Ar Clinical Institute Withdrawal Assessment of Alcohol Scale revised
BIG-P Brief Intervention in Gastroenterology Proforma
SADQ The Severity of Alcohol Dependence Questionnaire
AUDIT Alcohol Use Disorder Identification Test questionnaire
RTC-TRV Readiness to Change Questionnaire
Follow-up
Follow-Up Details 1-Month and 3-Month Follow-Ups
Querying on alcohol use will occur during these follow-ups Follow up assessment will be done virtually with telephonic phone calls
1 1-Month Follow-Up After 1 month of enrolment participants from both groups will be followed up by the research team through telephonic phone call Follow-up assessments include outcomes like relapse lapse or maintaining abstinence along with use of assessment tools like SADQ AUDIT and readiness to change
2 3-Month Follow-Up Like the 1-month follow-up participants from both groups will undergo follow-up assessments after 3 months
In addition to Follow up assessment done virtually with telephonic phone calls daily tracking in the mobile based application will be used as an additional source of information regarding the abstinence and relapse use of alcohol by the participant with the consent of participant
Participants randomized to the mobile health application group are expected to continue using the mobile health application regularly after discharge from the hospital
It is highly encouraged that the mobile health application is used at least once daily to track the progress utilize its features and receive ongoing support for a minimum period of 3 months
This regular usage is a crucial part of the study and participants are encouraged to engage with the mobile health application up to the 3-month follow-up point to maximize the interventions benefits
The follow-up assessment will be done using following
Brief Intervention in Gastroenterology Proforma BIG- P
The Severity of Alcohol Dependence Questionnaire SADQ
Alcohol Use Disorder Identification Test questionnaire AUDIT
Readiness to Change Questionnaire RTC -TRV
JUSTIFICATION NEED FOR THE STUDY The present studies suggest that a substantial proportion of patients with alcohol use disorders relapse to alcohol during the course of treatment Efforts are required to delay and avoid such relapse and maintain abstinence by effective treatment approaches A major barrier to care is the lack of adequately skilled human resources to deliver contextually appropriate treatments Nurse-conducted Brief Intervention supplemented with mobile application-based can be a beneficial approach to prevent relapse and support patients in their journey to overcome alcohol addiction It also promotes a more continuous and connected recovery process by enabling regular communication and data sharing between the user and their counsellor
Proposed Methodology Only males will be included in the study
Including women in this study would necessitate a gender-specific analysis 5 which could complicate the primary objective of evaluating the combined intervention of Nurse-Conducted Brief Intervention NCBI and a mobile based application
To maintain the internal validity of this study and to ensure a clear focused evaluation of the intervention the investigators have chosen to initially focus on male participants
The non-availability of female patients or a smaller number of female patients according to hospital admission records diagnosed with alcohol dependence admitted to the hospital ward due to stigma will also affect the data collection process
Future studies will aim to address the effectiveness of these interventions specifically for women considering their unique needs and responses to treatment
SAMPLE SIZE and the BASIS for the same
The sample size was calculated using the Sample size calculator riskcalcorg for superiority trial with a dichotomous outcome The investigators based the analysis on the prevalence rates of 65 by a study in Bangalore with a 2-side significance level of 005 Power 1-beta of 08 Ratio of sample size unexposedexposed of 1 Probability of event in the unexposed group 06 Probability of event in the exposed group 04 margin of difference of 05 with a 10 dropout rate the sample size estimated was 74 34 in each group
Considering the drop out approximately 40 patients will be taken in each group to achieve the target recruitment
Study design A Randomized controlled trial Study site In-patient setting of Department of Gastroenterology St Johns Medical College Bangalore
Reasons for the recruitment of subjects from the Gastroenterology department
Due to the availability of Nurse Conducted Brief intervention NCBI service in Gastroenterology department by trained nurse
High prevalence of Alcohol Use Disorders AUDs among patients admitted in Gastroenterology department Patients in this unit often present with issues directly related to their alcohol use making it an ideal setting for intervention
Subjects who are not currently in withdrawal and have been deemed medically stable by the treating physician in the Gastroenterology unit will be enrolled for the study This ensures that participants are medically stable and suitable for the study
Study Period 1 year Method of sampling Randomized sampling the study design is a randomized controlled trial In this type of study participants are randomly assigned to two different groups ie STATISTICAL ANALYSIS The data will be reviewed for normality The data will be presented as parametric or non- parametric depending on the distribution The chi-squared test will be used to find the difference between categorical variables An Independent sample t test would be used to find the differences between the means of the two groups Repeated measure ANOVA will be used for the outcome measures
ETHICAL CONSIDERATION
The study will commence after IEC approval SJMC and IRB approval of protocol of the study
Confidentiality will be maintained
Participation will be voluntary Approval of the Institutional Ethics committee will be sought Permission from the Head of Department of Gastroenterology will be sought to enrol patients from the department of Gastroenterology The participants will be briefed on the study and provided with explanations on how the gathered medical data could be used Informed consent will be obtained from the patients prior to enrolling in the study
Screening
All patients with alcohol use disorder will be identified through inclusion and exclusion criteria from inpatient settings of the Gastroenterology department at SJMCH Confidentiality will be maintained
They will be assessed with the Clinical Institute Withdrawal Assessment of Alcohol Scale revised CIWA-Ar for monitoring withdrawal symptoms
CIWA-Ar score less than 8 or after 3 days of admission the patient will be screened for major psychiatric illness using Modified Mini Screen MMS
The Modified Mini Screen MMS is a generic screening measure for mood anxiety and psychotic spectrum disorders There are twenty-two questions with yesno responses It takes about fifteen minutes to complete
Baseline Assessment
The Socio-demographic details will be collected from participants using BIG proforma
Brief Intervention in Gastroenterology proforma is an initiative of the Department of Psychiatry St Johns Medical College Bangalore which includes informed consent socio-demographic details of the participants details regarding their drinking pattern LFT values 4 sessions of Brief Intervention and follow up status abstinent lapse relapse expired
The Severity of Alcohol Dependence Questionnaire SADQ will be used to assess the severity of alcohol dependence Severity of Alcohol Dependence Questionnaire SADQ is a short easy-to-complete self-administered 20-item questionnaire designed to measure severity of dependence on alcohol
Alcohol Use Disorder Identification Test questionnaire will be used to screen the patient for alcohol use disorders The Alcohol Use Disorders Identification Test AUDIT is a 10-item screening tool developed by the World Health Organization WHO to assess alcohol consumption drinking behaviours and alcohol-related problems The AUDIT has been validated across genders and in a wide range of racialethnic groups and is well suited for use in primary care settings Scores for each question range from 0-4 For questions 9 and 10 which only have three responses the scoring is 0 2 and 4 from left to right A score of 8 or more is associated with harmful or hazardous drinking
Readiness to change questionnaire will be used to assess the motivation to abstain from alcohol This questionnaire is used to assess how they are motivated to abstain from alcohol It has 12 questions and is scored from -2 to 2 -2 being strongly disagree -1disagree 0unsure 1agree 2strongly agree
The whole study is a three-time assessment which might take approximately 30- 40 minutes to assess
It will be ensured that the caregiver is not made to travel exclusively for the purpose of this study
MMS Modified Mini Screen
CIWA - Ar Clinical Institute Withdrawal Assessment of Alcohol Scale revised
BIG-P Brief Intervention in Gastroenterology Proforma
SADQ The Severity of Alcohol Dependence Questionnaire
AUDIT Alcohol Use Disorder Identification Test questionnaire
RTC-TRV Readiness to Change Questionnaire
Follow-up
Follow-Up Details 1-Month and 3-Month Follow-Ups
Querying on alcohol use will occur during these follow-ups Follow up assessment will be done virtually with telephonic phone calls
1 1-Month Follow-Up After 1 month of enrolment participants from both groups will be followed up by the research team through telephonic phone call Follow-up assessments include outcomes like relapse lapse or maintaining abstinence along with use of assessment tools like SADQ AUDIT and readiness to change
2 3-Month Follow-Up Like the 1-month follow-up participants from both groups will undergo follow-up assessments after 3 months
In addition to Follow up assessment done virtually with telephonic phone calls daily tracking in the mobile based application will be used as an additional source of information regarding the abstinence and relapse use of alcohol by the participant with the consent of participant
Participants randomized to the mobile health application group are expected to continue using the mobile health application regularly after discharge from the hospital
It is highly encouraged that the mobile health application is used at least once daily to track the progress utilize its features and receive ongoing support for a minimum period of 3 months
This regular usage is a crucial part of the study and participants are encouraged to engage with the mobile health application up to the 3-month follow-up point to maximize the interventions benefits
The follow-up assessment will be done using following
Brief Intervention in Gastroenterology Proforma BIG- P
The Severity of Alcohol Dependence Questionnaire SADQ
Alcohol Use Disorder Identification Test questionnaire AUDIT
Readiness to Change Questionnaire RTC -TRV
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None