| CTRI Number |
CTRI/2025/01/079804 [Registered on: 30/01/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Nurse-led dyadic intervention on treatment adherence |
|
Scientific Title of Study
|
Effect of nurse-led dyadic intervention on treatment adherence of inpatients receiving clozapine therapy at NIMHANS, Bengaluru |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Simrat Kaur |
| Designation |
PhD Scholar |
| Affiliation |
National Institute of Mental Health and Neurosciences (NIMHANS) |
| Address |
Department of Nursing, National Institute of Mental Health and Neurosciences (NIMHANS), Hosur road, Bengaluru, 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
8342911456 |
| Fax |
|
| Email |
kaursimrat65@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sailaxmi Gandhi |
| Designation |
Professor, Department of Nursing |
| Affiliation |
National Institute of Mental Health and Neurosciences (NIMHANS) |
| Address |
Department of Nursing, National Institute of Mental Health and Neurosciences (NIMHANS), Hosur road, Bengaluru, 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
9902763889 |
| Fax |
|
| Email |
sailaxmi63@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sailaxmi Gandhi |
| Designation |
Professor, Department of Nursing |
| Affiliation |
National Institute of Mental Health and Neurosciences (NIMHANS) |
| Address |
Department of Nursing, National Institute of Mental Health and Neurosciences (NIMHANS), Hosur road, Bengaluru, 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
9902763889 |
| Fax |
|
| Email |
sailaxmi63@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
National Institute of Mental Health and Neurosciences (NIMHANS) |
| Address |
National Institute of Mental Health and Neurosciences (NIMHANS), Hosur road, Bengaluru, 560029 |
| 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 Sailaxmi Gandhi |
National Institute of Mental Health and Neurosciences |
Department of Psychiatry, Nursing division, National Institute of Mental Health and Neurosciences (NIMHANS), Hosur road, Bengaluru
Bangalore
KARNATAKA |
9902763889
sailaxmi63@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee (Behavioural Sciences- National Institute of Mental Health and Neurosciences (NIMHANS)) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G||Mental Health, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nurse-led-Dyadic Intervention |
The Nurse-led Dyadic Intervention includes nurse-led counseling sessions conducted over three consecutive days, lasting one hour each day, for patients initiated on clozapine and their caregivers.It also involves pill card monitoring, investigation card tracking, and audiovisual reinforcement through biweekly reminders via phone calls, text messages, or WhatsApp, provided over six months. A post-test is conducted after three month and six-month period. |
| Comparator Agent |
Routine care |
Routine care includes consultation by psychiatrist and information about the medication by the researcher. A post test is conducted after three month and six month period |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Inpatients
o All genders
o Patients diagnosed with schizophrenia and newly initiated on clozapine therapy.
o Between the age of 18-60 years.
o Patients who can understand Hindi and English.
o Patients accompanied by informal caregivers who will be actively involved in patient care on a day-to-day basis for at least six months.
Informal caregiver
o All genders
o Informal caregivers aged above 18 years.
o Informal caregivers who can understand Hindi and English
o Informal caregivers who are willing to regularly monitor pill card, investigation card, communicate with the researcher by phone once in every two weeks and actively involved in management and reporting of side effects.
|
|
| ExclusionCriteria |
| Details |
Patient
o Patients diagnosed with co-morbid intellectual disability.
Informal caregiver
o Informal caregivers with severe psychiatric or neurological disorders.
o Informal caregivers with any sensory deficits.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Adherence to medication |
Three months and six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Attitude towards medication, anthropometric measurements, haematological profile, biochemical profile, adherence to WBC monitoring, severity of illness, quality of life, socio occupational functioning, family burden |
3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
12/02/2025 |
| 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="0"
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
|
PROBLEM STATEMENT A Randomized Controlled Trial to evaluate the effect of nurse-led dyadic intervention on treatment adherence among inpatients receiving clozapine therapy admitted at NIMHANS, Bengaluru. AIM OF THE STUDY The research study aims to evaluate the effect of nurse-led dyadic intervention on medication adherence among patients undergoing clozapine therapy. RESEARCH QUESTION o How effective is a nurse-led dyadic intervention in improving medication adherence among patients undergoing clozapine therapy? OBJECTIVES Primary objectives o To evaluate the effect of a nurse-led dyadic intervention on medication adherence among patients undergoing clozapine therapy. Secondary Objectives o To evaluate the effect of a nurse-led dyadic intervention on patient’s attitude towards medication. o To assess the effect of the nurse-led dyadic intervention on anthropometric measures as well as, haematological and biochemical profile in patients undergoing clozapine therapy. o To evaluate the effect of the nurse-led dyadic intervention in adherence to white blood cell monitoring among patients undergoing clozapine therapy. o To assess the effect of nurse-led dyadic intervention on the severity of illness, quality of life, and socio-occupational functioning of patients undergoing clozapine therapy. o To evaluate the effect of nurse-led dyadic intervention on family burden. |