CTRI Number |
CTRI/2021/03/032254 [Registered on: 24/03/2021] Trial Registered Prospectively |
Last Modified On: |
15/08/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Screening Behavioral |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Nurse led brief intervention for reducing psychoactive substance use among elderly |
Scientific Title of Study
|
A Randomized controlled trial on the effectiveness of nurse led brief intervention to reduce risky use of psychoactive substance among members in the selected elderly organization of rohtak |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Neeraj |
Designation |
Msc Nursing Student |
Affiliation |
Pt. BD Sharma university of health science |
Address |
Department of Psychiatric Nursing, College of Nursing, PGIMS, ROHTAK
Rohtak HARYANA 124001 India |
Phone |
8708560696 |
Fax |
|
Email |
akhushi04387@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
JAISON JOSEPH |
Designation |
LECTURER (JR) |
Affiliation |
Pt. BD Sharma University of Health Sciences, Rohtak |
Address |
Department of Psychiatric Nursing, College of Nursing, PGIMS, Rohtak
Rohtak HARYANA 124001 India |
Phone |
9468277298 |
Fax |
|
Email |
jaisonjsph@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
JAISON JOSEPH |
Designation |
LECTURER (JR) |
Affiliation |
Pt. BD Sharma university of health science |
Address |
Department of Psychiatric Nursing, College of Nursing, PGIMS, Rohtak
Rohtak HARYANA 124001 India |
Phone |
9468277298 |
Fax |
|
Email |
jaisonjsph@yahoo.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Pt BDS PGIMS Rohtak |
Address |
College of Nursing, Pt BDS PGIMS Rohtak |
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 |
JAISON JOSEPH |
Pandit BDS PGIMS, Rohtak |
College of Nursing, Department of Psychiatric Nursing, Pandit BDS PGIMS, Rohtak Rohtak HARYANA |
9468277298
jaisonjsph@yahoo.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Biomedical research ethics committee, PGIMS, (UHS), Rohtak |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Elderly with risky use of substances |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
nurse led brief intervention |
session 1: WHO ASSIST linked brief intervention
Session: brief motivational structured module |
Comparator Agent |
routine advice |
routine advice with pamphlet |
|
Inclusion Criteria
|
Age From |
60.00 Year(s) |
Age To |
95.00 Year(s) |
Gender |
Male |
Details |
1) the elderly member of selected elderly organizing with using the psychoactive substance available during study period.
2) The elderly members using the psychoactive substance who are willing to take part in the study |
|
ExclusionCriteria |
Details |
1) patient were excluded from the stud who had attended an alcohol or and substance use treatment program.
2)The elderly member reported symptoms of withdrawal in the previous year |
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Risky use of psychoactive substance use as per WHO ASSIST scale |
4 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
Psychological morbidity according to PHQ4 |
At baseline |
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
01/04/2021 |
Date of Study Completion (India) |
15/05/2021 |
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
Modification(s)
|
Preparing for publication |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Title:- A Randomized Controlled Trial on the effectiveness of nurse led brief intervention to reduce risky use of psychoactive substance among members in the selected elderly organization of Rohtak. · Date collection method (plan for data collection): The study will be conducted in 2 phases. The purpose of Phase I is to screen the subjects for moderate and high risk of substance use involvement (“screen positive†subjects) in order to obtain the requisite sample for the next phase. The Phase II of the study will randomize the screen positive subjects to either ASSIST-linked BI (Intervention Group) or to non-specific general advice (Control Group). In the Phase II of the study, Screen positive subjects (Moderate and High Risk) will be first administered the other research instruments (Socio-Demographic Performa, Clinical Performa, PHQ-4). After this, they will be randomized into Intervention group and control group. Randomization: Block randomization will be used and equal numbers of participants into each group (intervention & control groups) Allocation concealment: Allocation concealment will be ensured by using sequentially numbered sealed envelopes. Following the written informed consent, the nurse will open a sealed envelope which will reveal the treatment allocation and the allocation in these envelopes will be determined by block-randomization process. Blinding: The study will be a single blinded study in which those who conduct follow-up assessment will be blinded to treatment allocation. After randomization, the Intervention group will be administered WHO ASSIST-linked BI package (approx.15-30 min single session). Brief Intervention is based on Motivational interviewing and FRAMES Model. It is a structured therapy of short duration (15- 30 minutes) is offered with an aim to help a person to reduce the use of substance. Session consists of discussing individualized harmful consequences of using substance, establishing clear link between substance consumption and the consequences, emphasizing the patient’s personal responsibility to change, evaluation of high risk situations, implementation of alternative highs, advice on coping strategies with facilitating self-efficacy and optimism. During intervention subjects will also be offer options to consult various treatment centre if they are in need. |