| 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
|
|
|
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
|
|
|
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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