CTRI Number |
CTRI/2021/09/036870 [Registered on: 27/09/2021] Trial Registered Prospectively |
Last Modified On: |
27/09/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Behavioral |
Study Design |
Other |
Public Title of Study
|
Including the concept of Identifying and giving brief advice for alcohol, tobacco and other drug users into the National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke. |
Scientific Title of Study
|
Integrating Screening and Brief Intervention for Substance Use Disorders into National
Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and
Stroke. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Anusha Viswanathan |
Designation |
Junior Resident |
Affiliation |
Kasturba Medical College, Manipal, MAHE |
Address |
Department of Community Medicine
3rd Floor Kasturba medical College MAHE
Opposite tiger circle
Manipal
Udupi
Karnataka-576104
Udupi KARNATAKA 576104 India |
Phone |
9940013215 |
Fax |
|
Email |
anusha.viswanathan@learner.manipal.edu |
|
Details of Contact Person Scientific Query
|
Name |
Dr Muralidhar M Kulkarni |
Designation |
Associate Professor |
Affiliation |
Department of Community Medicine, Kasturba Medical College, Manipal, MAHE |
Address |
Department of Community Medicine
3rd Floor Kasturba medical College MAHE
Opposite tiger circle
Manipal
Udupi
Karnataka-576104
Udupi KARNATAKA 576104 India |
Phone |
9844810917 |
Fax |
|
Email |
murali.kulkarni@manipal.edu |
|
Details of Contact Person Public Query
|
Name |
Dr Samir Kumar Praharaj |
Designation |
Professor and Head |
Affiliation |
Department of Psychiatry, Kasturba Medical College, Manipal, MAHE |
Address |
Department of Psychiatry
Kasturba Hospital
MAHE Manipal
Udupi
Karnataka-576104
Udupi KARNATAKA 576104 India |
Phone |
8971026304 |
Fax |
|
Email |
samir.kp@manipal.edu |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Kasturba Medical College Manipal |
Address |
Tiger Circle Road, Madhav Nagar, Manipal, Karnataka 576104 |
Type of Sponsor |
Private medical college |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Anusha Viswanathan |
Kasturba Medical College Manipal |
Community Medicine Department Primary Health care settings 1234 Udupi KARNATAKA |
9940013215
anusha.viswanathan@learner.manipal.edu |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee KMC Manipal |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Substance Use |
Patients |
(1) ICD-10 Condition: F102||Alcohol dependence, (2) ICD-10 Condition: F172||Nicotine dependence, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Cessation Trial |
The objective is to study the impact of Screening with help of “The Alcohol, Smoking and Substance Involvement Screening Test†(ASSIST) Score and Brief Intervention (BI) in quitting Substance use among substance users (Nicotine and alcohol use only)
BRIEF INTERVENTION is a brief motivational conversation between a health care professional and a substance user which focuses on encouraging healthy choices so that the risk behaviours are quit.
The Community Medicine department runs five peripheral health centres of which One centre will be chosen as the CONTROL and another centre for INTERVENTION to avoid contamination.
There will be 4-time points in this trial -baseline, 1st month, 3rd month and end line (6th month).
At baseline – The moderate risk substance users (as identified from the ASSIST TOOL) will be subjected to lab investigations (venous blood sample for GGT among alcohol users and urine sample for urine cotinine among nicotine users) in both arms. Further, BI will be administered to subjects in the intervention arm only.
At 1st month and 3rd month- The patients in both the arms will receive a 5-10-minute follow-up phone call, where PI will assess ASSIST score and enquire about the status of substance use. Further, adherence to the BI advice as well as any progress towards change will be enquired in the intervention arm alone.
At end line (6th month) personal follow-up- ASSIST scoring and the same lab investigations carried out at baseline will be repeated at the primary care centre to see the impact of Screening and brief intervention in quitting substance use in both arms. The BI will then be given to the control arm so that they are not deprived of the intervention.
The total duration to achieve this objective will be 6 months.
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
99.00 Year(s) |
Gender |
Both |
Details |
Patients coming to primary care centres will be included in the study if they are aged 18 and above.
Patients who will be alert and oriented to time, place and person.
Participant whose ASSIST score shows moderate risk during screening
|
|
ExclusionCriteria |
Details |
: Planned to leave the area in the next six months;
Not providing reliable contact information to complete the follow-up procedures;
Were currently in a residential substance abuse treatment facility.
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Effectiveness of brief intervention (BI) on QUITTING substance use.
|
There will be 4-time points in this trial -baseline, 1st month, 3rd month and end line (6th month) wherein substance usage status, ASSIST score will be evaluated in control and intervention arms. Additionally, at baseline and end-line (6th month) - the lab investigations (GGT among alcohol users and urine cotinine among nicotine users) will be carried out to see the impact of Screening and brief intervention in quitting substance use in both arms.
|
|
Secondary Outcome
|
Outcome |
TimePoints |
The study outcomes are thus likely to provide us the means to incorporate the Screening and Brief interventions for SUDs into the existing NPCDCS program which will in future ensure provision of tackling the menace of substance use in the country at primary health care level. |
2 years |
|
Target Sample Size
|
Total Sample Size="1120" Sample Size from India="1120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
28/09/2021 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
This study aims to identify the factors associated with substance use; barriers and facilitators for incorporating Screening and Brief Intervention (SBI) for Substance Use Disorders (SUDs) at primary level; and effectiveness of this intervention on substance use and thereby provide valuable insights for integrating this strategy into the ongoing National Programme for prevention & Control of Cancer, Diabetes, Cardiovascular diseases & Stroke (NPCDCS). Objectives of this study: Objective 1: To explore the barriers and facilitators for implementing screening and brief intervention (SBI) for Substance use disorders at primary health care settings. Objective 2: To estimate the proportion of substance users among people seeking health care services at primary health care settings and to study the factors associated with substance use. Objective 3: To study the impact of SBI in quitting substance use. Sample size for 3 objectives are mentioned below:-Objective 1: In-Depth Interview (IDI) will be conducted among 12-15 participants that comprise of Primary care physicians; health care providers like nurses, medical social workers; NCD coordinators and the NPCDCS program officer after obtaining their consent.Objective 2: 1108 (calculated using prevalence of substance use = 15% (Panda et al) Total sample size is 1120 (12 participants from objective 1 + 1108 participants from objective 2) Objective 3: The Sample size is found to be 82. Thus, the control arm will have 41 and the intervention arm will have 41 participants |