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CTRI Number  CTRI/2025/07/090412 [Registered on: 07/07/2025] Trial Registered Prospectively
Last Modified On: 27/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study to Assess the Effect of a Nursing Support Program on Reducing Stress and Improving Knowledge Among Caregivers of Stroke Patients After Hospital Discharge 
Scientific Title of Study   Development and Evaluation of a Multimodal Approach to Nursing Care (MANC) Module Versus Traditional Practice of Family Caregivers for Patients of Cerebrovascular Accident Discharged from a Tertiary Care Hospital.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Patricia Santosh Reddy 
Designation  Associate Professor 
Affiliation  Shrimati Radhikabai Meghe Memorial College of Nursing 
Address  Shrimati Radhikabai Meghe Memorial (SRMM) College of Nursing, Datta Meghe Institute of Medical Sciences (Deemed to be University), Sawangi (Meghe), Wardha – 442001, Maharashtra, India

Wardha
MAHARASHTRA
442001
India 
Phone  08380094958  
Fax    
Email  patriciareddy4@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Ranjana Sharma 
Designation  Principal 
Affiliation  Datta Meghe Institute of higher education and Research Centre 
Address  Shalinitai Meghe College of Nursing, Salod Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  9960027855  
Fax    
Email  ranjanasharma1234@rediffmail.com,  
 
Details of Contact Person
Public Query  
Name  Patricia Santosh Reddy 
Designation  Associate Professor 
Affiliation  Shrimati Radhikabai Meghe Memorial College of Nursing 
Address  Shrimati Radhikabai Meghe Memorial (SRMM) College of Nursing, Datta Meghe Institute of Medical Sciences (Deemed to be University), Sawangi (Meghe), Wardha – 442001, Maharashtra, India

Wardha
MAHARASHTRA
442001
India 
Phone  08380094958  
Fax    
Email  patriciareddy4@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Patricia Reddy 
Address  Shrimati Radhikabai Meghe Memorial (SRMM) College of Nursing, Datta Meghe Institute of Medical Sciences (Deemed to be University), Sawangi (Meghe), Wardha – 442001, Maharashtra, India 
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 Ranjana Sharma  Acharya Vinoba Bhave Rural Hospital (AVBRH)  Acharya Vinoba Bhave Rural Hospital (AVBRH), Neurology department Datta Meghe Institute of Medical Sciences (Deemed to be University), Sawangi (Meghe), Wardha – 442001, Maharashtra, India
Wardha
MAHARASHTRA 		 9960027855

ranjanasharma1234@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Institute of higher education and research center ethics Committee.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I693||Sequelae of cerebral infarction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Multimodal Approach to Nursing Care (MANC) Module  Disease-specific education (e.g., stroke recovery, complication prevention) Device care training (e.g., feeding tubes, urinary catheters) Progressive Muscle Relaxation (PMR) sessions provided twice a week for 12 weeks Psychological support and caregiver counseling Follow-up via in-person or telephonic support Assessments conducted at baseline (pre-test), mid-point (6 weeks), and post-intervention (12 weeks) include caregiver burden, knowledge, self-efficacy, and quality of life. 
Comparator Agent  Traditional Family Caregiving Practice  Control group caregivers continue routine post-discharge care based on standard hospital discharge instructions without additional structured nursing intervention. No progressive muscle relaxation, follow-up education, or psychological support is provided. Assessments are done in parallel with the intervention group (baseline, mid-point, and post-intervention) for caregiver burden, knowledge, self-efficacy, and quality of life. 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Family caregivers who are the primary caregivers of patients diagnosed with neurological disorders.
Caregivers of patients who have been discharged with specific medical devices such as Foley catheters or nasogastric (NG) tubes.
Caregivers aged 18 years or older.
Caregivers who provide direct care to the patient at home after discharge.
Caregivers who are willing to participate in the multimodal intervention, including educational support, and Progressive muscle Relaxation (PMR) techniques.
Caregivers who provide written informed consent to participate in the study.
 
 
ExclusionCriteria 
Details  Caregivers who are healthcare professionals (e.g., nurses, therapists) providing care outside of their professional capacity.
Caregivers of patients who have additional severe co-morbid conditions that may require specialized care beyond the scope of the study.
Caregivers who are unwilling to participate in Progressive muscle Relaxation (PMR) techniques or other components of the multimodal intervention.
Caregivers who do not speak the language in which the intervention is delivered and cannot comprehend the study materials.
Caregivers who reside far from the hospital make regular follow-up and intervention participation impractical.
Caregivers with a terminal illness or a prognosis that may prevent them from participating throughout the study period.
who are currently enrolled in other clinical trials or research studies that may confound the outcomes of the present study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in caregiver stress and burden.
Caregiver knowledge and competence 		 Baseline at 6week and after 12 week 
 
Secondary Outcome  
Outcome  TimePoints 
Caregiver Self-Efficacy in Device management  Baseline and after 12th week 
Caregiver Quality of Life  Baseline and after 12th week 
Patient Health Outcome  Baseline and after 12th week 
Feedback
satisfaction with MANC module 		 Baseline and after 12th week 
 
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   Phase 2 
Date of First Enrollment (India)   15/09/2025 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   This study aims to evaluate the effectiveness of a Multimodal Approach to Nursing Care (MANC) Module compared to traditional caregiving practices among family caregivers of patients discharged after cerebrovascular accident (stroke). The MANC intervention includes structured education on stroke management, medical device care, psychological support, and progressive muscle relaxation (PMR) sessions delivered over a 12-week period. The hypothesis is that caregivers receiving the MANC Module will show significantly greater improvements in stress reduction, caregiving knowledge, self-efficacy, and quality of life, as compared to those receiving standard care alone. The study follows a randomized controlled trial design with 194 participants, divided equally between intervention and control arms. 
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