| CTRI Number |
CTRI/2024/10/075339 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
24/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Assessment of adaptation and effectiveness of a brief Adherence Therapy on selected outcome variables among patients with Alcohol use disorders. |
|
Scientific Title of Study
|
A quasi-experimental study to assess the adaptation and effectiveness of a brief “Adherence therapy†on selected outcome variables among patients with Alcohol use disorders registered in DDTC OPD, PGIMER, Chandigarh 2023-25 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
CHETNA |
| Designation |
MSC Nursing Student |
| Affiliation |
National Institute of Nursing Education, sector 12, PGIMER Chandigarh ,India |
| Address |
Room no. 209, Department of Nursing, National Institute of Nursing Education, sector 12, PGIMER Chandigarh ,India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7814923161 |
| Fax |
|
| Email |
ranachetna42@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SUNITA SHARMA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
National Institute of Nursing Education, PGIMER Chandigarh, India |
| Address |
Room no. 210, Department of National Institute of Nursing Education, PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9876269615 |
| Fax |
|
| Email |
sanitasuni@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SUNITA SHARMA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
National Institute of Nursing Education, PGIMER, Chandigarh, India |
| Address |
Room no. 210 Department of National Institute of Nursing Education, PGIMER, Chandigarh, India.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9876269615 |
| Fax |
|
| Email |
sanitasuni@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Post graduate Institute of Medical Education and Research, Chandigarh, India
|
|
|
Primary Sponsor
|
| Name |
Post graduate Institute of Medical Education and Research Chandigarh India |
| Address |
Post graduate Institute of Medical Education and Research, Chandigarh, India
CHANDIGARH
160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Chetna |
Postgraduate Institute of Medical education and research |
Room No.108 Department of Drug de addiction and treatment Centre ,Division-Department of Psychiatry, Postgraduate Institute of Medical education and research Chandigarh
Chandigarh
CHANDIGARH |
7814923161
ranachetna42@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, PGIMER,Chandigarh |
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 |
| Intervention |
Adaptation and effectiveness of a brief Adherence therapy |
A quasi-experimental study to assess the adaptation and effectiveness of a brief “Adherence therapy†on selected outcome variables among patients with Alcohol use disorders registered in DDTC OPD, PGIMER, Chandigarh 2023-25 |
| Intervention |
Adherence therapy |
Adherence therapy will be given to experimental group and comparator group will received routine care and pretest or posttest will be done of both experimental group and control group. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.New patients registered in DDTC OPD |
|
| ExclusionCriteria |
| Details |
Patient on multiple drug abuse except tobacco abuse |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Adherence therapy help in improving treatment adherence related to Alcohol use disorder |
2 months follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This therapy help in reducing craving, increasing abstinence time ,decreasing drop out rate and increasing medication adherence |
one weak |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
29/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
29/10/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
The aim of the therapy is improving treatment adherence and improving patient outcome of Alcohol use disorder. This therapy will help in reducing craving, increasing abstinence time, decreasing dropout rate and increasing medication adherence by providing strategies to improve medication adherence such as remembering cues, health education regarding medication and motivation interviewing and solve barriers related to medication adherence. |