CTRI Number |
CTRI/2025/04/084921 [Registered on: 16/04/2025] Trial Registered Prospectively |
Last Modified On: |
15/04/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Other (Specify) [PALLIATIVE CARE] |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
To see effectiveness of palliative care in amyotrophic lateral sclerosis when integrated early, a randomised control study |
Scientific Title of Study
|
Efficacy of early integration of palliative care in amyotrophic lateral sclerosis : A Randomised Control Trial |
Trial Acronym |
nil |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Rakshitha Latha Veeraragavalu |
Designation |
Junior Resident (MD), Palliative Medicine |
Affiliation |
All India Institute of Medical Sciences, New Delhi |
Address |
PCU, Room no 154, DR BRA IRCH, All India Institute Of Medical Science, Ansari nagar, New Delhi, 110029
New Delhi DELHI 110029 India |
Phone |
9035948394 |
Fax |
|
Email |
rakshithalv@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Sushma Bhatnagar |
Designation |
Professor and Head, Onco-anaesthesia and Palliative Medicine |
Affiliation |
All India Institute of Medical Sciences, New Delhi |
Address |
PCU, Room no 154, DR BRA IRCH, All India Institute Of Medical Science, Ansari nagar, New Delhi, 110029
New Delhi DELHI 110029 India |
Phone |
9811326453 |
Fax |
|
Email |
sushmabhatnagar1@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Sushma Bhatnagar |
Designation |
Professor and Head, Onco-anaesthesia and Palliative Medicine |
Affiliation |
All India Institute of Medical Sciences, New Delhi |
Address |
PCU, Room no 154, DR BRA IRCH, All India Institute Of Medical Science, Ansari nagar, New Delhi, 110029
New Delhi DELHI 110029 India |
Phone |
9811326453 |
Fax |
|
Email |
sushmabhatnagar1@gmail.com |
|
Source of Monetary or Material Support
|
Department of Onco-anaesthesia and Palliative Medicine, DR BRA IRCH, AIIMS, NewDelhi |
|
Primary Sponsor
|
Name |
DR BRA IRCH, AIIMS, New Delhi |
Address |
DR BRA IRCH, AIIMS, New Delhi, Ansari nagar, New Delhi, 110029 |
Type of Sponsor |
Research institution and hospital |
|
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 Rakshitha Latha Veeraragavalu |
AIIMS, New Delhi |
Department of Neurology, AIIMS, New Delhi
Ansarinagar, New Delhi, 110029 New Delhi DELHI |
9035948394
rakshithalv@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Ethics Committee, All India Institute Of Medical Science, New Delhi |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: G122||Motor neuron disease, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Integrated palliative care with standard of care |
Palliative care management includes, timely pain management and other symptom management, feeding procedures, physiotherapy, symptomatic care, supportive care to patients and care givers, advance care planning |
Comparator Agent |
Provision of standard of care to newly diagnosed cases of amyotrophic lateral sclerosis |
Provision of standard of care to newly diagnosed cases of amyotrophic lateral sclerosis and palliative care will be integrated after 6 months. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
99.00 Year(s) |
Gender |
Both |
Details |
a.All patients clinically diagnosed with ALS presenting to Neurology OP and IPD AIIMS, New Delhi during the study period.
b.All consenting adult patients above 18 years of age.
c.Patients who can understand hindi/English
|
|
ExclusionCriteria |
Details |
a. Patients who do not understand Hindi or English
b. Age less than 18 years
c.Patients who are in altered mental state or unable to provide relevant clinical history and patients in the process of dying.
d.Patients not willing to participate in the study.
e.Patients with other CONCOMITANT chronic life limiting illnesses (ESRD, CVA, Metastatic malignancies, ESLD, Cardiac failure)
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To assess the efficacy of early integration of palliative care interventions in improving the quality of life at baseline 3 and 6 months compared to standard of care |
Baseline, 3rd month and 6th month |
|
Secondary Outcome
|
Outcome |
TimePoints |
To assess the overall symptom burden in patients and care givers. |
0,3,6 months |
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
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)
|
30/04/2025 |
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="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
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
|
Amyotrophic lateral sclerosis (ALS) previously known as Lou Gehrig’s disease is a progressive neurodegenerative disease that primarily affects motor neurons, in the brain and spinal cord, which are crucial for transmitting signals to muscles which results in loss of voluntary muscle control. Incidence in the Indian setting: 1.5–2.7 cases per 100,000 people annually. Prevalence of 3–5 cases per 100,000 people at any given time. Despite the growing recognition of the importance of palliative care for individuals with ALS, there are significant gaps in the data concerning their care needs. There is a lack of longitudinal studies that track the effectiveness of palliative interventions throughout the progression of the disease. Most existing research focuses on short-term outcomes, making it difficult to evaluate long-term care requirements and results, particularly for those who live with ALS for many years. Additionally, there is limited solid evidence on the most effective strategies for managing the full range of ALS symptoms. Research on various models of palliative care delivery, which could enhance quality of life, alleviate symptoms, and improve survival, is also insufficient. Moreover, there is a need for more information on caregiver burden and ways to ensure they receive adequate support. Communication regarding prognosis, treatment goals, and end-of-life preferences continues to be a significant challenge. |