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CTRI Number  CTRI/2024/05/067745 [Registered on: 21/05/2024] Trial Registered Prospectively
Last Modified On: 14/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Effect of education on anxiety, depression and burden among caregivers of stroke patients 
Scientific Title of Study   Effect of education on anxiety, depression and burden among caregivers of stroke patients: An experimental 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  Acharya Yashaswi Shankar 
Designation  Post graduate student 
Affiliation  NITTE Institute of Physiotherapy, NITTE Deemed to be University 
Address  Department of Physiotherapy, Room No 20, Second Base Division, NITTE Institute of Physiotherapy, NITTE Deemed to be University, Deralakatte, Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  8310494135  
Fax    
Email  yashaswi.acharya@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Purusotham Chippala 
Designation  Professor 
Affiliation  NITTE Institute of Physiotherapy, NITTE Deemed to be University  
Address  Department of Physiotherapy, Room No 20, Second Base Division, NITTE Institute of Physiotherapy, NITTE Deemed to be University, Deralakatte, Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9916460185  
Fax    
Email  chippala_puru@nitte.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Purusotham Chippala 
Designation  Professor 
Affiliation  NITTE Institute of Physiotherapy, NITTE Deemed to be University 
Address  Department of Physiotherapy, Room No 20, Second Base Division, NITTE Institute of Physiotherapy, NITTE Deemed to be University, Deralakatte, Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9916460185  
Fax    
Email  chippala_puru@nitte.edu.in  
 
Source of Monetary or Material Support  
NITTE institute of physiotherapy, NITTE (Deemed to be university) will provide basic infrastructure facilities. No other monitory support is required. Room No 20, Department of Physiotherapy, Second Base Division, NITTE Institute of Physiotherapy, NITTE Deemed to be University, Deralakatte, Mangaluru, Karnataka, India, Pincode 575018 
 
Primary Sponsor  
Name  NITTE Institute of Physiotherapy 
Address  NITTE Institute of Physiotherapy, NITTE Deemed to be University, Nithyananda Nagar, Deralakatte, Mangaluru, Dakshina Kannada, Karnataka 575018 India 
Type of Sponsor  Other [Constituent Physiotherapy Institute of NITTE Deemed to be University] 
 
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 Purusotham Chippala  Justice K. S Hegde Charitable Hospital  Department room no 10, Department of Medicine, Medical science complex, Deralakatte, Mangaluru- 575018
Dakshina Kannada
KARNATAKA 		 9916460185

chippala_puru@nitte.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of NITTE Institute of Physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Caregivers of Stroke patients 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Caregiver education program  Day 1: Understanding Stroke and Its Impact Focus: Introduce the basics of stroke: its nature, types, symptoms, diagnosis and treatment. There will be a question and answer session to address individual concerns and knowledge gaps. Day 2: Managing Risk Factors and Complications Focus: Explore common risk factors for stroke and strategies for prevention. Discuss potential complications and early warning signs. Day 3: Education about the Importance of Caregiving Techniques and Physiotherapy Focus: Introduce education for daily care, including safe transfers, positioning, fall prevention, skincare, and feeding assistance through pamphlets. Day 4: Review and Recap Briefly review key points from the previous sessions and reinforce learned caregiving education. Answer any remaining questions and express appreciation for participant involvement. The participants will receive education for 30 minutes per day for 4 days. The principal investigator will administer the following methodology.  
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Caregiver being a family member (Parents, siblings, spouse, cousins)
2. Acute stroke hospitalized patients
3. Caregiver capable of communicating in English or Kannada or Tulu and understanding instructions 
 
ExclusionCriteria 
Details  1. Caregivers who are not willing to give consent and participate in the study
2. ZBI score less than 21
3. HADS score less than 7
4. Formal/Paid caregivers
5. Caregivers of Unconscious patients and severe stroke
6. Any other neurological conditions 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Hospital anxiety and depression scale (HADS)
2. Zarit burden interview 		 Pre intervention (Day 1) and Post intervention (Day 4) 
 
Secondary Outcome  
Outcome  TimePoints 
Length of hospital stay   Pre Intervention (Day 1) and Post intervention (Day 4) 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="26" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/07/2024 
Date of Study Completion (India) 01/02/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 major contributor to long-term and debilitating neurological impairments, impacting a significant portion of stroke survivors. Stroke causes physical and mental disabilities, as well as dependence on one’s family who are often ill-equipped for the demands of caregiving. In such cases, the families suffer from severe crisis and anxiety due to the unexpected incidence of the disease and unawareness of the associated consequences. 
Caregivers face emotional and physical issues due to a lack of knowledge of the conditions, duration of the hospitalization, financial burden, and demand. Existing literature states that there is a high prevalence of depression and anxiety symptoms among caregivers of stroke survivors, which were 40.2% and 21.4%, respectively. Both anxiety and depression were positively correlated with the total care burden score. Previous studies suggest that appropriate home care guidance and education, counselling, and social support should be provided to caregivers to reduce their
physical and mental burden. 
This study is designed to help create awareness and better understanding regarding anxiety, depression, caregiver burden, and also the caregiving process and importance of physiotherapy to take better care of the stroke survivor and caregiver through caregiver education in the future. 
 
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