Health Condition 1: G238- Other specified degenerative diseases of basal ganglia Health Condition 2: G318- Other specified degenerative diseases of nervous system Health Condition 3: G231- Progressive supranuclear ophthalmoplegia [Steele-Richardson-Olszewski] Health Condition 4: G232- Striatonigral degeneration
Conditions
Interventions
Intervention1: Outpatient palliative care: 1. Comprehensive Assessment
Multidimensional evaluation: physical, psychological, social, and spiritual domains
Identification of symptom burden, careg
Sponsors
Rajat Kamra
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Patient quality of life assessed by PDQ-39. 2. Caregiver burden assessed by ZBI-12.Timepoint: 0,3,6,9,12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. Timepoint: 0,3,6,9,12 months | — |
Countries
India
Contacts
Public ContactDr Divya MR
All India Institute Of Medical Sciences Delhi
Outcome results
None listed