| CTRI Number |
CTRI/2024/01/062155 [Registered on: 31/01/2024] Trial Registered Prospectively |
| Last Modified On: |
23/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Telephonic intervention] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study of Brief Telephonic Intervention in patients with Alcohol Dependence |
|
Scientific Title of Study
|
A Study of Weekly Brief Telephonic Intervention in patients with Alcohol Dependence |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shobhit Nain |
| Designation |
Junior Resident |
| Affiliation |
King George Medical University |
| Address |
Department of Psychiatry, Gate no 11, King George Medical University, Lucknow- 226003, Uttar Pradesh, India
Lucknow
UTTAR PRADESH
220063
India |
| Phone |
7905189081 |
| Fax |
|
| Email |
shobhitnain@kgmcindia.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Amit Singh |
| Designation |
Assistant Professor |
| Affiliation |
King Georges Medical University |
| Address |
Department of Psychiatry, Gate no 11, King George Medical University, Lucknow- 226003, Uttar Pradesh, India
Lucknow
UTTAR PRADESH
220063
India |
| Phone |
8853817280 |
| Fax |
|
| Email |
amitsingh0612@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SHOBHIT NAIN |
| Designation |
Junior Resident |
| Affiliation |
King George Medical University |
| Address |
Department of Psychiatry, Gate no 11, King George Medical University, Lucknow- 226003, Uttar Pradesh, India
Lucknow
UTTAR PRADESH
220063
India |
| Phone |
7905189081 |
| Fax |
|
| Email |
shobhitnain@kgmcindia.edu |
|
|
Source of Monetary or Material Support
|
| King Georges Medical University, Lucknow - 226003 |
|
|
Primary Sponsor
|
| Name |
King Georges Medical University Lucknow |
| Address |
1, Shah Mina Road , Chowk, Lucknow |
| 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 Shobhit Nain |
King Georges Medical University, Lucknow |
Department Of Psychiatry, King Georges Medical University, Shah Mina Road, Chowk
Lucknow
UTTAR PRADESH |
7905189081
shobhitnain@kgmcindia.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KING GEORGES MEDICAL UNIVERSITY 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 |
Standard treatment as usual with no telephonic intervention |
The control group will not receive any telephonic intervention and will only receive treatment as usual |
| Intervention |
Standard treatment as usual with weekly Telephonic intervention every week for 8 weeks |
The intervention group will receive a brief telephonic intervention every week for 8 weeks and they will be assessed for Lapse, Relapse, or any challenges related to medication adherence. The Brief intervention given via telephone will explore circumstances leading to lapse, relapse, provide supporting statements, address issues with treatment adherence and reminder for next follow up will be given.
Total duration of intervention is 8 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who are willing to give informed consent.
2.Diagnosis of alcohol dependence as per ICD-11.
3.Age between 18 and 60 years.
4.Clinical Institute Withdrawal Assesment of Alcohol Scale, Revised score less than 8.
|
|
| ExclusionCriteria |
| Details |
1.A current diagnosis of any other psychiatric disorder except nicotine dependence and personality disorder
2.Patients who cannot be contacted telephonically.
3.Presence of comorbid physical illnesses that preclude their participation into the study
4.Use of alcohol within last 7 days.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The patients of alcohol dependence receiving brief telephonic intervention will have greater cumulative abstinence duration( total number of days abstinent from alcohol) compared to those not receiving it. |
2 , 4 and 8 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Difference in Cumulative abstinence duration( total number of days abstinent from alcohol)
Difference in quality of life between groups
Difference in well being scores between groups
Difference in relapse rates
Difference in dropout rates |
2 , 4 and 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
03/02/2024 |
| Date of Study Completion (India) |
26/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
Alcohol use disorder is chronic psychiatric illness associated with high rates of relapse. Treatment retention
and adherence to medication is a huge problem in the health care system. Poor
adherence can only lead to the worsening of the disease and increase the costs
and resources taken up by the hospitals as patients who adhere poorly to the
treatment tend to visit the hospitals more often to seek treatment. As a
result, it becomes extremely important to identify and tackle the problem in
the most effective way. There have been numerous studies done in the west that
have proven that reminders in form of text messages and through various mobile
apps have improved treatment adherence not only in case of alcohol dependence
but also in other illnesses that require long term treatment. There is a
paucity of research on this strategy from India. Besides, the effectiveness of
regular telephonic reminders in AUD is less researched . All the
Participants aged 18 to 60 years attending adult psychiatry OPD and addiction
treatment clinic OPD will be screened and first 3 subjects fulfilling the
selection criteria will be enrolled in the study. Study information will be
provided to patients and informed consent will be obtained. Diagnosis will be
ascertained and psychiatric co-morbidities will be ruled out clinically, using
ICD-11. At baseline, semi-structured questionnaire will be used to collect
information about sociodemographic data concerning family, social,
psychological, medical, and legal problems and history of substance use
pattern. Patients will be randomized using computer generated random table
method into Intervention and Control group and allocation concealment will be
done using sealed envelope method. Clinical Institute Withdrawal Assessment for
Alcohol (CIWA- Ar ), Alcohol use disorder identification test (AUDIT) ,Visual analogue scale (VAS) , WHO-QoL BREF
and WHO well-being scale will be applied in both groups at baseline. The intervention group will receive a
brief telephonic intervention every week for 8 weeks and they will be assessed
for Lapse, Relapse, or any challenges related to medication adherence. The
Brief intervention given via telephone will explore circumstances leading to
lapse, relapse, provide supporting statements, address issues with treatment
adherence and reminder for next follow up will be given. The control group will
not receive any telephonic intervention and will only receive treatment as usual.
Assessment will be performed in person at Department of Psychiatry, KGMU in
both the groups at 2, 4 and 8 weeks that will include assessing Quality of life
using WHO QOL-Bref and WHO well-being scale, lapses , relapses, No of days
alcohol consumed and amount using Timeline follow back ( TLFB ) ,Dropouts,
Medication adherence ( Self/ Family reported adherence to medication) ,Craving
using Visual Analogue Scale. The study will be continued for patients who had a
lapse but who did not relapse. At the end of study Cumulative abstinence
duration will be measured in both groups. Intention to treat analysis will be
done and for missing data, Last Observation Carried Forward(LOCF) will be used.
Data collected will be statistically analyzed.
|