| CTRI Number |
CTRI/2024/02/062228 [Registered on: 01/02/2024] Trial Registered Prospectively |
| Last Modified On: |
18/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [ASSIST Linked Brief Intervention (ALBI)] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of counselling on male security guard personnel working in UHS rohtak |
|
Scientific Title of Study
|
“A study to assess the effectiveness of nurse conducted brief intervention to reduce risky patterns of substance use among male security guard personnel employed at UHS, Rohtak†|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kajol |
| Designation |
M.Sc 2nd year student |
| Affiliation |
College of Nursing ,PGIMS ,Rohtak |
| Address |
College of nursing ,PGIMS ,Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9896116222 |
| Fax |
|
| Email |
kajal.sanduja11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajeshwari Devi |
| Designation |
Junior Lecturer |
| Affiliation |
College of Nursing , PGIMS ,Rohtak |
| Address |
College of Nursing ,junior lecturer ,room no-16,PGIMS ,Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8168460994 |
| Fax |
|
| Email |
rajeshwaridevi263@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajeshwari Devi |
| Designation |
Junior Lecturer |
| Affiliation |
College of Nursing , PGIMS ,Rohtak |
| Address |
College of Nursing ,junior lecturer ,room no-16 ,PGIMS ,Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8168460994 |
| Fax |
|
| Email |
rajeshwaridevi263@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Nursing ,PGIMS, Rohtak |
|
|
Primary Sponsor
|
| Name |
Kajol |
| Address |
college of nursing,PGIMS ROHTAK |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Jr Lecturer Rajeshwari Devi |
Hospital |
Security Office ,Pt. B.D Sharma health sciences and university ,UHS ,Rohtak
Rohtak
HARYANA |
8168460994
rajeshwaridevi263@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee (BREC) Pt. B.D Sharma Post Graduate Institute of Medical Sciences UHS Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ASSIST Linked Brief intervention (ALBI) |
Screening,done and brief intervention given ,referral for tretment for high risk(SBIRT),post assessment |
| Comparator Agent |
health education on substance used by them |
helath education of about 5 -10 min on their used substance |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
1. who provide consent for participation.
2. male security guard |
|
| ExclusionCriteria |
| Details |
1. Guards who do not provide consent .
2. Guards who are absent during data collection. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| changes in habits of substance use |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduced in amount of taking substances.or seeking medical advice. |
15 days |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
07/02/2024 |
| 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="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
This study is Randomized parallel group trial with participant blinding so we will see the effectiveness of nurse led brief intervention to reduce the risky pattern of substance used among male security guard personnel in 1month after giving ASIST linked brief intervention .The primary outcome will be measured after 2 weeks of brief intervention to see any change in pattern of substance use or any other change in habits. |