| CTRI Number |
CTRI/2026/01/100316 [Registered on: 05/01/2026] Trial Registered Prospectively |
| Last Modified On: |
04/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to assess the efficacy of adding symptoms focused supportive care to regular neurological treatment can improve daily comfort and quality of life for patients and reduce stress for their caregivers |
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Scientific Title of Study
|
EFFICACY OF COMBINING OUTPATIENT PALLIATIVE CARE WITH STANDARD CARE ON QUALITY OF LIFE AND CAREGIVER BURDEN IN ATYPICAL PARKINSONIAN SYNDROME – A RANDOMISED CONTROLLED TRIAL |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Rajat Kamra |
| Designation |
DM resident |
| Affiliation |
All India Institute Of Medical Sciences Delhi |
| Address |
NS5, Cardiothoracic and Neurosciences Centre, AIIMS New Delhi
New Delhi
DELHI
110016
India |
| Phone |
9541319282 |
| Fax |
|
| Email |
Connectwithdoctorrajat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya MR |
| Designation |
Associate Professor |
| Affiliation |
All India Institute Of Medical Sciences Delhi |
| Address |
Room number 602 6th floor Neurosciences Centre AIIMS Delhi
New Delhi
DELHI
110029
India |
| Phone |
9958034273 |
| Fax |
|
| Email |
dr.divyamr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya MR |
| Designation |
Associate Professor |
| Affiliation |
All India Institute Of Medical Sciences Delhi |
| Address |
Room number 602 6th floor Neurosciences Centre AIIMS Delhi
New Delhi
DELHI
110029
India |
| Phone |
9958034273 |
| Fax |
|
| Email |
dr.divyamr@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences New Delhi |
|
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Primary Sponsor
|
| Name |
Rajat Kamra |
| Address |
73A Yusuf Sarai New Delhi 110016 |
| Type of Sponsor |
Other [Self] |
|
|
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 Rajat Kamra |
OPD and NS5, Cardiothoracic and Neurosciences Centre, AIIMS, New Delhi |
All India Institute Of Medical Sciences Delhi
New Delhi
DELHI |
9541319282
Connectwithdoctorrajat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, All India Institute of Medical Sciences, New Delhi |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G238||Other specified degenerative diseases of basal ganglia, (2) ICD-10 Condition: G318||Other specified degenerative diseases of nervous system, (3) ICD-10 Condition: G231||Progressive supranuclear ophthalmoplegia [Steele-Richardson-Olszewski], (4) ICD-10 Condition: G232||Striatonigral degeneration, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Outpatient palliative care |
1. Comprehensive Assessment
• Multidimensional evaluation: physical, psychological, social, and spiritual domains
• Identification of symptom burden, caregiver issues, functional status, and goals of care
2. Symptom Management
• Motor & non-motor symptom assessment
• Pain evaluation and management (WHO analgesic ladder approach)
• Management of fatigue, sleep disorders, autonomic dysfunction
• Assessment of swallowing, nutrition, respiratory symptoms, sleep-disordered breathing
• Mobility optimisation, assistive devices, and pressure ulcer prevention
Checklist-based approach used in every visit
3. Psychosocial Support (Patient)
• Screening for anxiety/depression
• Counselling and coping-skills training
• Social support strategies to reduce isolation
• Cognitive–behavioural interventions where appropriate
4. Caregiver Support
• Assessment of caregiver burden
• Stress management and coping interventions
• Education on disease trajectory and care techniques
• Work–life balance counselling
5. Advance Care Planning
• Family-centred goals-of-care discussions
• Advance directive completion
• Healthcare proxy designation
• End-of-life preference exploration with patient and family
6. Spiritual Care
• Assessment of spiritual and existential concerns
• Counselling and connection with relevant community/religious resources
7. Family Support
• Family dynamics evaluation
• Conflict-resolution support
• Preparing families for progression of illness
• Counselling for role adjustment
8. Care Coordination
• Enhanced communication with treating neurologists
• Home safety assessment & modifications as needed
• Training of caregivers for essential care tasks
|
| Comparator Agent |
Standard Neurological Care |
Participants in the control arm will receive routine neurological management as per current clinical practice for atypical parkinsonian syndromes. Care will focus on optimisation of symptomatic pharmacotherapy, including:
• Dopaminergic therapy: levodopa/carbidopa, dopamine agonists (e.g., pramipexole, ropinirole) or amantadine, where clinically appropriate.
• Autonomic dysfunction: fludrocortisone or midodrine for orthostatic hypotension (with non-pharmacological measures), antimuscarinic or Beta 3-agonist agents (solifenacin, oxybutynin, mirabegron) for urinary symptoms, and laxatives for constipation.
• Pain management: optimisation of dopaminergic therapy, NSAIDs, antiepileptics, TCAs, SNRIs, opioids, or botulinum toxin where indicated.
• Neuropsychiatric symptoms: SSRIs/SNRIs for depression; quetiapine or clozapine for psychosis.
• Other symptom management: domperidone or ondansetron for nausea; hyoscine or glycopyrronium for drooling; clonazepam or melatonin for RBD; botulinum toxin for focal dystonia or sialorrhea when required.
Participants will undergo routine follow-up every 3 months with reassessment of clinical and functional parameters.
No structured palliative care visits, multidisciplinary symptom reviews, formal caregiver counselling, or systematic symptom-monitoring interventions will be provided in this arm. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria
Participants will be enrolled if they meet all the following criteria
Diagnosis
Participants must have a clinically established or probable Atypical Parkinsonian Syndrome including the following
Progressive Supranuclear Palsy fulfilling the MDS PSP two thousand seventeen criteria
Multiple System Atrophy fulfilling the MDS MSA two thousand twenty two criteria
Corticobasal Syndrome fulfilling the Armstrong et al two thousand thirteen criteria
Dementia with Lewy Bodies fulfilling the McKeith et al two thousand seventeen consensus criteria
Stage or Severity Palliative Need Threshold
Presence of at least two symptoms each scoring four or more on the Edmonton Symptom Assessment Scale for Parkinsons Disease
Moderate to high palliative care needs defined as a score of two or more on the modified Palliative Care Needs Assessment Tool
Age
Participants must be adults aged eighteen years or older
Caregiver Availability
A primary informal caregiver such as a spouse family member or non professional attendant must be available and willing to participate in the program
Healthcare professionals or paid attendants cannot serve as primary caregivers for this study
Caregivers are identified by the response to the question
Could you please tell us the one person a family member or close friend who helps you the most by providing ten hours or more of care per week outside of the clinic
For patients with dementia family caregivers may self identify to provide relevant information
Language and Communication
Participants and caregivers must be able to converse in Hindi or English to ensure comprehension of consent forms and study questionnaires
Consent
Written informed consent must be provided by both the patient and the caregiver
If the patient lacks decision making capacity consent may be obtained from a legally acceptable representative
Follow Up Feasibility
The participant must be able and willing to attend all scheduled in person follow up visits at three months and six months |
|
| ExclusionCriteria |
| Details |
Exclusion Criteria
Participants will be excluded if any of the following apply
Disease Mimics
Secondary Parkinsonism including drug induced vascular psychogenic and post encephalitic causes or any other neurodegenerative disorder that does not meet the criteria for Atypical Parkinsonian Syndromes
Early Stage Disease
Participants with mild newly diagnosed disease without significant symptom burden or palliative needs defined as fewer than two symptoms in the Edmonton Symptom Assessment Scale for Parkinsons Disease or individual symptom scores of three or less or a modified Palliative Care Needs Assessment Tool score of less than two
Urgent Palliative Care Requirement
Participants who have urgent palliative care needs and require immediate intervention as determined by the treating clinician including
Aspiration and dysphagia crisis
Recurrent or injurious falls
Autonomic failure or autonomic crisis
Severe pain rigidity or dystonia
Delirium hallucinations or sudden cognitive decline
Psychological or behavioural disturbance
End of life or imminent decline
Caregiver collapse or caregiver crisis
Recurrent infections or pressure injuries
Uncontrolled secretions and dyspnoea
Absence of Caregiver
No identifiable primary caregiver or caregiver unavailable or unwilling to participate
Comorbid Terminal or Unstable Systemic Illness
Participants with advanced malignancy end stage cardiac hepatic or renal failure or any other life limiting systemic illness that requires independent palliative services
Prior Structured Palliative Care Enrolment
Participants who are currently enrolled in or have recently that is within the past six months been discharged from a formal palliative care or hospice program |
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Patient quality of life assessed by PDQ-39.
2. Caregiver burden assessed by ZBI-12. |
0,3,6,9,12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Symptoms Burden assessed by ESAS-PD
2. Psychological Distress assessed by HADS
3. Caregiver satisfaction assessed by FAMCARE-6.
4. Global Clinical Impression assessed by CGI-I and CGI-S
5. Healthcare utilization assessed by number of hospital admission and ER Visits.
|
0,3,6,9,12 months |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
15/01/2026 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The primary purpose of this study is to determine whether the addition of structured outpatient palliative care to standard neurology care leads to meaningful improvement in patient quality of life and reduction in caregiver burden in individuals with atypical parkinsonian syndromes. APS including PSP,MSA,CBS and DLB are progressive disorders characterized by severe motor and nonmotor symptoms high functional dependency and substantial caregiver stress Despite these complex needs palliative care remains underutilised in APS This trial seeks to evaluate whether early multidisciplinary outpatient palliative care delivered alongside standard neurology management can improve symptom control enhance daily functioning support psychosocial needs and alleviate caregiver distress Outcomes will be assessed using validated tools PDQ-39 for quality of life and ZBI-12 for caregiver burden at baseline and follow up visits at 3,6,9,12 months
Study Hypothesis is whether Combining outpatient palliative care with standard neurology care improves patient quality of life and reduces caregiver burden in people with APS
|