| CTRI Number |
CTRI/2024/04/066463 [Registered on: 29/04/2024] Trial Registered Prospectively |
| Last Modified On: |
29/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
REACH: Researching Variables Associated with Non-adherence to Psychotropic Medications in Severe Mental Illnesses Leading to Hospitalization |
|
Scientific Title of Study
|
A study on factors associated with psychotropic medication non-adherence among persons with severe mental illness experiencing relapse and necessitating inpatient care at a tertiary psychiatric center |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shah Daivik Rupeshkumar |
| Designation |
Junior Resident of Psychiatry |
| Affiliation |
National Institute of Mental Health And Neurosciences |
| Address |
Department of Psychiatry
NIMHANS, Bangalore
-
Bangalore
KARNATAKA
560029
India |
| Phone |
08073843654 |
| Fax |
|
| Email |
shahdaivik98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sundernag Ganjekar |
| Designation |
Junior Resident of Psychiatry |
| Affiliation |
National Institute of Mental Health And Neurosciences |
| Address |
Department of Psychiatry
NIMHANS
Hosur road, Bangalore
Department of Psychiatry
NIMHANS
Hosur road, Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
9686976128 |
| Fax |
|
| Email |
drbsnake@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shah Daivik Rupeshkumar |
| Designation |
Junior Resident of Psychiatry |
| Affiliation |
National Institute of Mental Health And Neurosciences |
| Address |
Department of Psychiatry
NIMHANS, Bangalore
-
Bangalore
KARNATAKA
560029
India |
| Phone |
08073843654 |
| Fax |
|
| Email |
shahdaivik98@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Mental Health and Neurosciences
Hosur Road
Bangalore
Karnataka-560029
|
|
|
Primary Sponsor
|
| Name |
National Institute of Mental Health and Neurosciences |
| Address |
NIMHANS
Hosur Road, Lakkasandra, Behind Bus Stop, Bengaluru, Karnataka 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 Shah Daivik Rupeshkumar |
National Institute of Mental Health and Neurosciences |
Department of Psychiatry NIMHANS, Hosur road, Bangalore - 560029
Bangalore
KARNATAKA |
8073843654
shahdaivik98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee - Behavioral Sciences Division |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F311||Bipolar disorder, current episodemanic without psychotic features, (2) ICD-10 Condition: F332||Major depressive disorder, recurrent severe without psychotic features, (3) ICD-10 Condition: F200||Paranoid schizophrenia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants above the age of 18 years
2. The participant has been admitted with relapse or exacerbation of an illness.
3. Medication non-adherence – Individuals who have completely stopped their therapeutic medications (antipsychotics, antidepressants, and mood stabilizers) for more than or equal to one week since requiring inpatient care.
4. Participants/family caregivers providing informed consent.
|
|
| ExclusionCriteria |
| Details |
Patients experiencing relapse of symptoms due to factors other than non-adherence e.g., first episode of severe mental illness, break through episode or is strictly due to substance use.
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
BPRS scale will be used to assess baseline severity of psychopathology following which SOFIA scale will be applied to assess reason for medication nonadherence.
OUTCOMES
To assess the factors associated with non-adherence to psychotropic medication.
To assess if a specific disorder or class of psychotropic medication is disproportionately high in association with non-adherence.
|
No intermediate time points in this trial.
Data and outcome will be assessed after completion of interviewing 150 patients. After the complete data is available estimated after 1 year - data/outcome it will be assessed
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess if a specific disorder or class of psychotropic medication is disproportionately high in association with non-adherence.
|
No pre-specified time points.
Data will be analyzed after completion of interviewing 150 patients.
After the complete data is available estimated after 1 year - data/outcome it will be assessed
|
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
10/05/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Non-adherence to psychotropic medication is a deeply concerning issue that leads to the worsening of psychopathology, frequent relapse necessitating re-hospitalization, and a barrier in the transition of individuals with severe mental disorders to their pre-morbid selves. Although Adherence is an individual behavior it is not the responsibility of the patient alone and factors affecting non-adherence need to be analyzed thoroughly. There is a paucity of studies evaluating factors associated with non-adherence comprehensively among patients having a relapse and requiring inpatient care, especially in the Indian population. Hence this motivates the current study which aims to examine the factors associated with medication non-adherence among patients with severe mental illness resulting in relapse requiring inpatient care. This will be prospective cross-sectional hospital-based study with the aim to identify the factors associated with medication non-adherence leading to relapse of psychopathology requiring hospitalization. |