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CTRI Number  CTRI/2025/01/079490 [Registered on: 27/01/2025] Trial Registered Prospectively
Last Modified On: 19/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Understanding Health, Quality of Life, and Caregiver Challenges in Post-Stroke Patients Living in Rural Areas 
Scientific Title of Study   Health Seeking Behaviour, Quality Of Life And Caregiver Burden Among Post Stroke Patients Residing In Rural Area - A Community Based Cross Sectional Study 
Trial Acronym  NIL  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  J Mohamed Rizwan 
Designation  Junior Resident 
Affiliation  Jawaharlal Nehru Medical College, KAHER 
Address  Jawaharlal Nehru Medical College, KAHER, Department of Community Medicine, Nehru Nagar

Belgaum
KARNATAKA
590010
India 
Phone  7010770072  
Fax    
Email  rizunique2025@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Deepti M Kadeangadi 
Designation  Professor 
Affiliation  Jawaharlal Nehru Medical College, KAHER 
Address  Jawaharlal Nehru Medical College, KAHER, Department of Community Medicine Nehru Nagar

Belgaum
KARNATAKA
590010
India 
Phone  9448021749  
Fax    
Email  drdeeptimk1979@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Deepti M Kadeangadi 
Designation  Professor, Department of Community Medicine 
Affiliation  Jawaharlal Nehru Medical College, KAHER 
Address  Jawaharlal Nehru Medical College, KAHER, Department of Community Medicine Nehru Nagar

Belgaum
KARNATAKA
590010
India 
Phone  9448021749  
Fax    
Email  drdeeptimk1979@gmail.com  
 
Source of Monetary or Material Support  
Dr. J. Mohamed Rizwan, Jawaharlal Nehru Medical College, KAHER, Department of Community Medicine Nehru Nagar, Belagavi, Karnataka, India-590010 
 
Primary Sponsor  
Name  Jawaharlal Nehru Medical College, KAHER 
Address  Nehru Nagar, Belagavi Karnataka - 590010 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Deepti M Kadeangadi  Jawaharlal Nehru Medical College, KAHER  Department of Community Medicine, Shiv Nagar, Kinaye, Bahadarwadi, Karnataka, India 590014
Belgaum
KARNATAKA 		 9448021749

drdeeptimk1979@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC Institutional Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G822||Paraplegia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.All stroke patients more than 18 years of age diagnosed by a physician for both ischaemic and haemorrhagic will be included for study
2.Ability to provide informed consent by the stroke patients/family members 
 
ExclusionCriteria 
Details  1.The patients who are admitted in hospital at the time of taking survey
2.The patients who could not be contacted after three consecutive visits
3.Severe cognitive impairment or mental illness that would impede the ability to participate in the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1 To assess the knowledge and practices about health seeking behaviour among post stroke patients in rural belagavi  1 year (April 2024-March 2025) 
 
Secondary Outcome  
Outcome  TimePoints 
2 To determine the quality of life of stroke patients using WHOQOL-BREF.
3 To assess the caregiver burden using ZARIT BURDEN INTERVIEW.
 		 1 year ( April 2024-March 2025) 
 
Target Sample Size   Total Sample Size="104"
Sample Size from India="104" 
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)   01/04/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Stroke is a sudden, unpredictable event causing significant mortality and disability worldwide, particularly in lower-income countries. According to WHO, the lifetime risk of stroke has increased by 50% in 17 years, with 1 in 4 people expected to experience a stroke. India reports a high stroke burden, with prevalence rates ranging from 84 to 424 per 100,000 population and early onset between 55-65 years. Public awareness of stroke symptoms and post-stroke care is alarmingly low, especially in rural areas, where only a small fraction recognize symptoms or healthcare services. Post-stroke survivors face diminished quality of life, measurable using tools like WHOQOL-BREF. Caregivers, often unpaid family members, experience significant physical, emotional, and financial strain, as assessed by the Zarit Burden Interview. Despite the critical need, community-based studies on stroke awareness, quality of life, and caregiver burden are limited, especially in rural settings, highlighting an urgent need for targeted interventions 
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