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CTRI Number  CTRI/2025/12/099740 [Registered on: 23/12/2025] Trial Registered Prospectively
Last Modified On: 22/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Design and Development of a Hospice and Respite Care Model to Improve Quality of Life  
Scientific Title of Study   Design and development of hospice and respite care structure and care process 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Medha Sharma 
Designation  junior resident  
Affiliation  Kasturba Medical college 
Address  department of hospital administration 4th floor old opd block kasturba hospital manipal

Udupi
KARNATAKA
576104
India 
Phone  09837354102  
Fax    
Email  medhasharma846@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Somu G  
Designation  Professor  
Affiliation  Kasturba Medical college 
Address  department of hospital administration 4th floor old opd block kasturba hospital manipal

Udupi
KARNATAKA
576104
India 
Phone  09837354102  
Fax    
Email  somu.g@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Medha Sharma 
Designation  junior resident  
Affiliation  Kasturba Medical college 
Address  department of hospital administration 4th floor old opd block kasturba hospital manipal

Udupi
KARNATAKA
576104
India 
Phone  09837354102  
Fax    
Email  medhasharma846@gmail.com  
 
Source of Monetary or Material Support  
Manipal Hospice and Respite Centre havanje  
 
Primary Sponsor  
Name  nil 
Address  nil 
Type of Sponsor  Other [nil] 
 
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 Arunangshu Ghoshal  manipal hospice and respite centre   manipal hospice and respite centre havanje , manipal
Udupi
KARNATAKA 
9434890160

arun.ghoshal@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee -2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  a) A terminal diagnosis with life expectancy of six months or less if the disease follow
normal progression. Examples: Advanced cancer, end-stage organ failure (e.g., heart,
lung, liver, or kidney disease), or neurodegenerative disorders (e.g., ALS, Parkinson’s,
or advanced dementia).
b) Discontinuation of Curative Treatment Patient has chosen comfort-focused care over
life-prolonging treatment
c) for uncontrolled symptoms patient required specialized palliative support eg – pain ,
dyspnea  
 
ExclusionCriteria 
Details  a) Patient actively pursuing curative or aggressive life-prolonging
treatments (e.g, chemotherapy, surgery).
b) Non-Terminal Conditions Chronic illness without a terminal prognosis.
c) Acute Psychiatric or Behavioural Conditions Requires inpatient psychiatric
intervention not managed in Hospice.
d) Need for Intensive Hospital Monitoring Patient requires ICU-level support or frequent
emergency interventions.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
the scope and structure of hospice/respite care, including physical layout,
available services, and support systems.
Identification of key differences and best practices in hospice care that can be communicated between
palliative and hospice care. Reduction in hospital readmissions and improvement in QALY for patients
under hospice feedback from caregivers and families (via satisfaction surveys)
Higher average length of stay indicating earlier access
 
6 months 
 
Secondary Outcome  
Outcome  TimePoints 
ALOS, Readmission rate, QALY, Bed Occupancy rate.
cost effective analysis reduced hospitalisation, family satisfaction, caregiver burnout reduction). 
1 year 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   05/01/2026 
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="30" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Aim of this study is to develop an ethically sound and effective hospice care system by optimizing clinical and operational process, improving infrastructure and incorporating innovate and patient center approaches. the initiative seek to enhance 

the quality of palliative care and safeguarding the comfort, dignity and rights, and overall well-being of patients receiving end of life care. 

Objective 1: To study the design of hospice and respite care structure in terms of manpower, Infrastructural requirement and to assess the administrative, financial and systemic implications. 

Objective 2: To compare quality of care between hospice care and palliative care and make suggestions for improvement. 

Objective 3: To integrate innovative approach for hospice care that prioritize and enhance patient comfort, dignity and overall well-being. 

The process begins with a need assessment, where surveys, interviews, or focus group discussions are conducted to understand existing perceptions, knowledge gaps, and common misconceptions related to hospice care. This step is crucial in tailoring the messaging to suit the cultural, emotional, and informational needs of the target audience. the planning phase involves defining clear communication objectives, identifying target groups (such as terminally ill patients, families, healthcare providers, and the broader community), selecting appropriate channels of communication, and allocating the necessary budget and resources. The messaging is then developed around core themes such as symptom control, emotional and spiritual support, patient dignity, and caregiver well-being. , the facility ensures the training of staff and volunteers so that the delivery of information remains consistent, compassionate, and accurate. monitoring and evaluation, which involves measuring the reach and effectiveness. This is done by tracking the number of materials distributed, sessions conducted, referrals made, and through pre- and post-campaign surveys that assess changes in awareness and behavior. Feedback is also collected from caregivers and patients to continuously refine the communication strategy. The entire process is cyclical and iterative, allowing for continuous improvement and responsiveness to the evolving needs of the community, much like the PDCA (Plan-Do-Check-Act) model often used in quality improvement systems. Hospice and respite care aim to provide comfort-focused, dignity-preserving end-of-life care.CEA compares cost(capital + operational) with outcome (QALYs gained, symptom relief, reduced hospitalization, family satisfaction, caregiver burnout reduction).


 
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