| CTRI Number |
CTRI/2019/08/020530 [Registered on: 02/08/2019] Trial Registered Prospectively |
| Last Modified On: |
02/08/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of a brief motivational intervention in reducing alcohol consumption in the emergency department |
|
Scientific Title of Study
|
Effect of a brief motivational interventions in reducing alcohol consumption among young patients visiting emergency department: a randomized controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajesh Kumar |
| Designation |
Assistant Professor |
| Affiliation |
ALL India institute of Medical Sciences (AIIMS) Rishikesh |
| Address |
College of Nursing, All India Institute of Medical Sciences (AIIMS) Rishikesh Uttarakhand
College of Nursing, ALL India institute of Medical Sciences (AIIMS) Rishikesh Uttarakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7055911523 |
| Fax |
|
| Email |
rajesh.nur@aiimsrishikesh.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Kumar |
| Designation |
Assistant Professor |
| Affiliation |
ALL India institute of Medical Sciences (AIIMS) Rishikesh |
| Address |
College of Nursing, ALL India institute of Medical Sciences (AIIMS) Rishikesh Uttarakhand
College of Nursing, ALL India institute of Medical Sciences (AIIMS) Rishikesh Uttarakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7055911523 |
| Fax |
|
| Email |
rajesh.nur@aiimsrishikesh.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh Kumar |
| Designation |
Assistant Professor |
| Affiliation |
ALL India institute of Medical Sciences (AIIMS) Rishikesh |
| Address |
College of Nursing, ALL India institute of Medical Sciences (AIIMS) Rishikesh Uttarakhand
College of Nursing, ALL India institute of Medical Sciences (AIIMS) Rishikesh Uttarakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7055911523 |
| Fax |
|
| Email |
rajesh.nur@aiimsrishikesh.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Emergency medicine
All India Institute of Medical Sciences, Rishikesh |
| Department of Trauma and Surgery All India Institute of Medical Sciences, Rishikesh |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Rishikesh |
| Address |
All India Institute of Medical Sciences Virbhadra Marg
Rishikesh Uttarakhand 249203 |
| 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 |
| Dr Rajesh Kumar |
Trauma & emergency department of AIIMS Rishikesh |
Department of Emergency Medicine , Room No 43, ER
Dehradun
UTTARANCHAL |
7055911523
rajesh.nur@aiimsrishikesh.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee IEC AIIMS Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F101||Alcohol abuse, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Motivational Enhancement Therapy |
A trained psychologist will conduct the intervention through an interview with the patient following the Miller and Rollnick protocol. It will be conducted within 5 days after the visit to the ED to increase the patient’s intrinsic incentive for change and stimulate his/her resolve. It will take 30 and 45 min. |
| Comparator Agent |
standard Hospital Care |
The control group received only a self-assessment tool, written advice on the risks of alcohol consumption and a list of contacts of specialized alcohol abuse professionals. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
(b) Can speak Hindi/local language
(c) Use of AUDIT for screening of alcoholism
(d) they reported ingesting alcohol within the 6 hours before their injury; or
(e) they scored positive for harmful or hazardous drinking on the Alcohol Use Disorders Identification Test (AUDIT)
(f) volunteer to participate in clinical trial
|
|
| ExclusionCriteria |
| Details |
a) Subjects without a permanent address in the city,
b) interview impossible due to severe physical condition (e.g. unconscious or pain),
c) psychotic disorders or mentally challenged at clinical anamnesis evaluation,
d) evident cognitive damage at clinical anamnesis evaluation,
e) subjects under arrest,
f) subjects being assisted or undergoing treatment at addiction care centres,
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Alcohol related negative consequences
Readiness to change behaviour
Quality of life |
3 months
3 months
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life |
6 months |
|
|
Target Sample Size
|
Total Sample Size="252"
Sample Size from India="252"
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)
|
01/10/2019 |
| 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="6"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
FIndings will be published at the end of the trial. No interim analysis is planned. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study aims to investigate the efficacy of a brief motivational enhancement therapy in reducing alcohol consumption among patients visiting trauma and emergency department at AIIMS, Rishikesh. A randomised control trial-parallel design is chosen for the study. A computer random number table will be used to randomise the patient in to experimental and control arm. Sequentially numbered, opaque, sealed envelopes will be used for allocation sequence of the participants. |