| CTRI Number |
CTRI/2023/12/060759 [Registered on: 26/12/2023] Trial Registered Prospectively |
| Last Modified On: |
22/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to understand what happened to patients with alcohol use disorders once they visit a tertiary care psychiatry center in South India |
|
Scientific Title of Study
|
A Naturalistic Follow-up Study to Assess the current Alcohol Use Status, Follow-up Rates, and Follow Up-pathways of Persons With Alcohol Use Disorders from a Tertiary Care Center in South India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Soyuz John |
| Designation |
Assistant Professor |
| Affiliation |
Manipal Academy of Higher education, Kasturba Medical College |
| Address |
Department of Psychiatry, Kasturba Medical College (KMC), Manipal, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8867604011 |
| Fax |
|
| Email |
soyuzjohn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Soyuz John |
| Designation |
Assistant Professor |
| Affiliation |
Manipal Academy of Higher education, Kasturba Medical College |
| Address |
Department of Psychiatry, Kasturba Medical College (KMC), Manipal, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka
KARNATAKA
576104
India |
| Phone |
8867604011 |
| Fax |
|
| Email |
soyuzjohn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Soyuz John |
| Designation |
Assistant Professor |
| Affiliation |
Manipal Academy of Higher education, Kasturba Medical College |
| Address |
Department of Psychiatry, Kasturba Medical College (KMC), Manipal, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka
KARNATAKA
576104
India |
| Phone |
8867604011 |
| Fax |
|
| Email |
soyuzjohn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Psychiatry, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College |
| Address |
Department of Psychiatry, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka |
| 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 |
| Samir Kumar Praharaj |
Kasturba Medical College |
Room no 13, Department of Psychiatry, Kasturba Medical College (KMC)
Udupi
KARNATAKA |
8971026304
samir.kp@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F102||Alcohol dependence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
patient with Alcohol use disorders and who participated in the previous study |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| the follow up pathway follwed by patient with alcohol use disorder once they report a tertiary psychiatry center |
1 year after the hospital visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="110" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title of the project: A
Naturalistic Follow-up Study to Assess the current Alcohol Use Status,
Follow-up Rates, and Follow Up-pathways of Persons with Alcohol Use Disorders
from a Tertiary Care Center in South India
Aim
The
present study aims to assess the alcohol use status, follow-up rates and
follow-up pathways of persons with AUDs after two years
Objectives
1. To
assess the current level of alcohol use of the patients
2. To
determine the follow up rates of the patients with AUDs
3. To
study the pathway patients, follow after reaching a tertiary care treatment
center (service providers they visited, number time of visits, reasons and
services received)
Sample
size: we have a cohort of 110 patients who took
treatment for the first time for AUD from the Department of Psychiatry KMC
Manipal and recruited for the pathways to care study in March 2021. As part of
the current study, we are planning to contact all the 110 patients/family
members over phone and collect the data.
Tools used:
WHO
encounter form:
Data on follow up pathways be collected by using the WHO encounter form which
was used in WHO pathway study and thereafter extensively used in ‘pathway to
care’ studies across different settings and countries. It is a culture neutral
questionnaire designed to systematically assess sources of care used by patients
and it is available in the public domain (Gater et al., 2005).
WHO,
AUDIT: It is
a 10-item screening tool for assessing alcohol consumption, drinking patterns,
and alcohol-related issues. Each question contains a range of options for
responses, and each option gets a score ranging from 0 to 4. A score of 8-15
indicates increasing risk, 16-19 shows higher risk, and 20 or more indicates
dependence (Babor et al., 2001). It is available in the public domain.
An
Interview schedule
will be developed to collect details regarding the current follow up status,
reasons for drop outs from the study and other relevant information.
processes: First
of all, the study will get clearance from Department Scientific Committee then
will be submitted to the Institute Ethics Committee of KMC Hospital for
clearance. Once we get the clearance, the 110 participants of study –titled
“Pathways to Care of Persons With Alcohol Use Disorders; A Descriptive Study
From A Tertiary Care Center of South India IEC no- (IEC-669/2020) will be
listed and their hospital numbers obtained from the previous proforma/ excel
sheet. The Researchers will explain abut the study, objectives and process to
the study participants and obtain online consent from them. After that, the
current alcohol use pattern will be assessed using an AUDIT questionnaire. Then
it will assess the pathway the patients followed after consulting the
psychiatry tertiary care center (Department of Psychiatry, KMC, Manipal) using
the WHO Encounter form. If the patient is not following up with the tertiary
care center, the reasons for not coming back also will be collected. One of the
family members also will be interviewed to corroborate the information given by
the patient. |