CTRI/2026/01/100316尚未招募不适用
EFFICACY OF COMBINING OUTPATIENT PALLIATIVE CARE WITH STANDARD CARE ON QUALITY OF LIFE AND CAREGIVER BURDEN IN ATYPICAL PARKINSONIAN SYNDROME – A RANDOMISED CONTROLLED TRIAL
Rajat Kamra1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年1月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
研究者
Dr. Rajat Kamra
All India Institute Of Medical Sciences Delhi
研究点 (1)
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