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CTRI Number  CTRI/2021/12/038521 [Registered on: 08/12/2021] Trial Registered Prospectively
Last Modified On: 07/12/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Behavioral 
Study Design  Other 
Public Title of Study   Effectiveness of primary caregiver-mentoring program for the management of schizophrenia at psychiatry out patient department, AIIMS Patna. 
Scientific Title of Study   Effectiveness of primary caregiver-mentoring program for management of schizophrenia at psychiatric out patient department, AIIMS Patna: A Quasi Experimental Study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manorama Singh Gautam 
Designation  M.Sc. NURSING 
Affiliation  All India Institute Of Medical Sciences, Patna, Bihar 
Address  Room no.10, ground floor, College Of Nursing, AIIMS Patna Bihar, Pincode-801507
Room no. 301, 3rd floor, Hostel no.5, AIIMS campus, AIIMS Patna, Bihar, Pincode-801507
Patna
BIHAR
801507
India 
Phone  7987890225  
Fax    
Email  manoramasg@aiimspatna.org  
 
Details of Contact Person
Scientific Query  
Name  Manorama Singh Gautam 
Designation  M.Sc. Nursing 
Affiliation  All India Institute Of Medical Sciences, Patna, Bihar 
Address  Room no.10, ground floor, College Of Nursing, AIIMS Patna Bihar, Pincode-801507
Room no. 301, 3rd floor, Hostel no.5, AIIMS campus, AIIMS Patna, Bihar, Pincode-801507
Patna
BIHAR
801507
India 
Phone  7987890225  
Fax    
Email  manoramasg@aiimspatna.org  
 
Details of Contact Person
Public Query  
Name  Naveen Kumar Sharma 
Designation  Assistant Professor  
Affiliation  All India Institute Of Medical Sciences, Patna, Bihar 
Address  Room no.42, 3rd floor, Department of Nursing, College Of Nursing, AIIMS, Patna, Bihar. Pincode-801507
Type 4 Block 2F. No. 111, AIIMS Residential Complex Patna, Pincode-801105.
Patna
BIHAR
801507
India 
Phone  8094058958  
Fax    
Email  drnaveenkumarsharma@aiimspatna.org  
 
Source of Monetary or Material Support  
All India Institute Of Medical Sciences Patna, Bihar, 801507 
 
Primary Sponsor  
Name  Naveen Kumar Sharma 
Address  Room no.42, 3rd floor, Department of Nursing, College Of Nursing, AIIMS, Patna, Bihar. Pincode-801507 
Type of Sponsor  Other [Government Medical University] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Pankaj Kumar  department of psychiatry, AIIMS Patna, Bihar. 
Hansmukh Jain  college of nursing, AIIMS, Patna, Bihar. 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
manorama singh gautam  All India Insititute Of Medical Sciences Patna, Bihar  C1A-Psychiatry In-patient Department, first floor, activity room, AIIMS Patna, Bihar.
Patna
BIHAR 		 7987890225

manoramasg@aiimspatna.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS Patna,Bihar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Individuals who are the caregiver of patients having schizophrenia. The individual must be providing primary care to the patient, administering medications and living with the patient. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  primary caregiver mentoring program  primary caregiver mentoring program is centered on psychoeducation related to the nature of illness, drug adherence and coping strategies. There will be two sessions of 30-40min each and at an interval of 2 weeks. 
Comparator Agent  standard treatment  standard treatment as usual without caregiver-mentoring program.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  58.00 Year(s)
Gender  Both 
Details  Caregivers of patients diagnosed with schizophrenia.
Age group 18 to 58 years old.
Participants who understands Hindi language.
Patients who are undergoing antipsychotic drug therapy
 
 
ExclusionCriteria 
Details  Caregivers who are unwilling to participate in the study.
Caregivers who are already suffering with any psychiatric illness.
Caregivers who are already attending any psychosocial intervention.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
medication adherence of schizophrenic patients measured by medication adherence rating scale(MARS).  positive score 5 and above signifies adherence to medication measured at an interval of 2 weeks.
 
 
Secondary Outcome  
Outcome  TimePoints 
1. association between selected sociodemographic variable and effectiveness of primary caregiver-mentoring program for management of schizophrenia.
2. association between effectiveness of primary caregiver-mentoring program and caregiver burden. 		 caregiver burden measured at an interval of 2 weeks.
 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   13/12/2021 
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="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The primary caregivers of the schizophrenic patients are the critical link between the patient and management of the treatment outcome. Due to the lack of basic knowledge related to illness and  management of adverse effects of drugs, there is further increase in the load of care on the patient’s primary caregivers and non-adherence to medication of patients. If the caregivers are provided with  knowledge and skills related to management of the patient’s illness, they will be able to provide care independently at their home more efficiently.

Since primary caregiver are playing the pivotal role in management of illness, especially in the medication administration, continuity in treatment of schizophrenic patient will be more effective if caregivers are actively involved in the management of illness and given sufficient knowledge and skills.

Rate of Medication non-adherence is  54.5% very significant in schizophrenic patient and should be considered while planning the treatment. The caregiver-mentoring session can play key role in reducing non-adherence toward medications in schizophrenic patients.

H0 -  There will be no significant difference in medication adherence among experimental group subjects after primary caregiver mentoring program compared to control group subjects as p < 0.05 level of significance.

H1 - There will be significant difference in medication adherence among experimental group subjects after primary caregiver mentoring program compared to control group subjects as p < 0.05 level of significance.

 
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