| CTRI Number |
CTRI/2025/02/079993 [Registered on: 06/02/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Executive function and Work performance in Alcoholics. |
|
Scientific Title of Study
|
Relation between executive function performance and work performance in patients with Alcohol Use Disorder. - A cross-sectional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Karuna Nadkarni |
| Designation |
In charge And Associate Professor |
| Affiliation |
Occupational Therapy School And Centre, Seth GSMC And KEM Hospital |
| Address |
1st floor, Occupational Therapy School and Centre, kem orthopedic centre, Seth GSMC And KEM Hospital, Parel, Mumbai 400012, Maharshtra, India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
7738922552 |
| Fax |
|
| Email |
karunanadkarni@kem.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Karuna Nadkarni |
| Designation |
In charge And Associate Professor |
| Affiliation |
Occupational Therapy School And Centre, Seth GSMC And KEM Hospital |
| Address |
Occupational Therapy School and Centre, Seth GSMC And KEM Hospital, Parel, Mumbai 400012, Maharshtra, India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
7738922552 |
| Fax |
|
| Email |
karunanadkarni@kem.edu |
|
Details of Contact Person
Public Query
|
| Name |
Richa Dewani |
| Designation |
post graduation student |
| Affiliation |
Occupational Therapy School And Centre, Seth GSMC And KEM Hospital |
| Address |
Occupational Therapy School and Centre, kem orthoppedic centre, Seth GSMC And KEM Hospital, Parel, Mumbai 400012, Maharshtra, India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9167090006 |
| Fax |
|
| Email |
moth202303@kem.edu |
|
|
Source of Monetary or Material Support
|
| the study will be conducted at occupational therapy training school and center
Seth GS medical college and KEM Hospital - tertiary care setup
|
|
|
Primary Sponsor
|
| Name |
Non sponsored |
| Address |
Occupational therapy training school and center, Seth GS medical college and KEM hospital
1st Floor, KEM Orthopaedic centre, Dr Ernest Borges Rd, opposite TATA MEMORIAL HOSPITAL, Parel East, Parel, Mumbai, Maharashtra 400012 |
| Type of Sponsor |
Government 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 |
| DrKaruna nadkarni |
OT School and centre, Seth GSMC and KEMH |
1st Floor, KEM Orthopaedic centre, Dr Ernest Borges Rd, opposite TATA MEMORIAL HOSPITAL, Parel East, Parel, Mumbai, Maharashtra 400012
Mumbai
MAHARASHTRA |
7738922552
karunanadkarni@kem.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F109||Alcohol use, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Adults with AUD with NUD (nicotine use disorder) and AUD With TUD (tobacco use disorder)
2.Adults reported to occupational therapy department for AUD
3.Participants score of the Screening tool
AUDIT should be 15 or more
MoCA should be 18 or more
|
|
| ExclusionCriteria |
| Details |
1.Participants with any additional psychiatric condition
2.Participants with any other neurological or orthopedic condition
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine relationship between executive function performance and work performance in patients with alcohol use disorder. |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To find and analyze the relationship between executive function performance and work performance.
2.To understand self-efficacy of participants about their need for help
|
18 months |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
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)
|
06/02/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
SUMMARY OF PROTOCOL TITLE OF THE STUDY – Relation between executive function performance and work performance in patients with Alcohol Use Disorder. - A cross-sectional study AIM AND OBJECTIVE AIM- To determine relationship between executive function performance and work performance in patients with alcohol use disorder. Objectives – 1. To assess executive function using executive function performance test - EFPT 2. To assess work performance using assessment of work performance - AWP 3. To find and analyze the relationship between executive function performance and work performance. 4. To understand self-efficacy of participants about their need for help STUDY DESIGN– Cross-sectional study SAMPLING TECHNIQUE – Convenient sampling STUDY SETTING –Patients will be recruited from the Occupational therapy department of the de-addiction center of a tertiary care hospital. The patients referred to occupational therapy for work fitness and regular intervention sessions on OPD and / or IPD setting will be recruited.
INCLUSION CRITERIA 1.Age group – 25-55 years 2. Adults diagnosed alcohol use disorder (AUD), including both males and females 3. Adults with AUD with NUD and AUD With TUD 4. Adults reported to occupational therapy department for AUD 5. Participants score of the Screening tool – AUDIT should be 15 or more MoCA should be 18 or more EXCLUSION CRITERIA 1. Participants with any additional psychiatric condition 2. Participants with any other neurological or orthopedic condition METHODOLOGY 1.Ethics approval 2.Sample size: 85 3.Participants will be recruited based on inclusion and exclusion Criteria. 4.Consent/assent will be taken from patients or caregivers. 5.Screening will be done using Alcohol use disorder identification test (AUDIT) and Montreal Cognitive Assessment (MoCA). 6.Assessment will be done using Executive function performance test (EFPT) and Assessment of work performance (AWP) 7.Data will be recorded and no follow up will be required. SCREENING TOOLS Alcohol use disorder identification test (AUDIT) Montreal Cognitive Assessment (MoCA) OUTCOME MEASURES– Executive function performance test (EFPT) Assessment of work performance (AWP) |