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临床试验/CTRI/2024/03/064196
CTRI/2024/03/064196尚未招募不适用

Burden of Post Stroke Depression and Risk Factor Identification

Dr. Parinitha Maben1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年2月7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
32
试验地点
1
主要终点
Diagnosis of post stroke depression as per ICD-10 criteria.

研究概览

简要总结

This cross-sectional observational study will be conducted among in-patients and out-patients of the Neurology department at Father Muller Medical College Hospital which is a multispecialty teaching hospital in Mangalore. It is a short study done as part of the post-graduate MD Psychiatry course.

Aim of the Study: To estimate the burden of post stroke depression (PSD) and identify its risk factors.

Objectives:

  1. To estimate the prevalence and severity of post stroke depression in the acute phase following stroke.

  2. To determine the factors contributing to the development post stroke depression.

  3. To identify an association if any between inflammatory markers and PSD.

  4. To identify an association if any between infarct location and PSD.

Sampling Method: Convenience (non-random) sampling.

Inclusion Criteria:

  1. Individuals who have been diagnosed with first or recurrent ischemic stroke.

  2. Patient with stroke within the past 3 months.

  3. Age group: Above 18 years

Exclusion Criteria:

  1. Patients with patients with impaired GCS, severe aphasia, cognitive impairment,

hearing/visual impairment interfering with meaningful communication.

  1. Patients with past history of psychiatric disorder.

  2. Patients with severe medical complications.

Method/study procedure:

The study will be conducted over a 3-month period after approval from the institutional scientific committee and ethics committee.

Written informed consent will be taken from each participant consenting to take part in the study. Participants will receive a patient information sheet explaining the study.

The investigator shall conduct face-to-face interviews with the study participants in the neurology wards at FMMCH, Mangalore.

Data will be collected in the form of a structured proforma, and using the instruments.

The Mini Mental Status Examination will be used to exclude patients with cognitive impairment.

All participants will be evaluated using the Post Stroke Depression Rating Scale (PSDRS) and The National Institutes of Health Stroke Scale (NIHSS).

MRI/CT brain done as part of diagnostic evaluation of stroke will be used to classify stroke lesion as left or right hemisphere, cortical or subcortical and size of infarct.

Hematological investigations done as part of stroke evaluation will be taken from hospital records to obtain values of inflammatory markers such as total WBC counts, ESR, RDW.

A structured proforma for sociodemographic data, clinical profile, stroke lesion location and duration of illness will be used.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • Male and female adult patients admitted with first or recurrent ischemic stroke with the most recent stroke within the past one month.

排除标准

  • Those patients in whom meaningful communication is impaired due to severe aphasia, cognitive impairment, hearing/visual impairment, those with past history of psychiatric illness and those with uncontrolled medical comorbidities and end stage organ failure.

结局指标

主要结局

Diagnosis of post stroke depression as per ICD-10 criteria.

时间窗: Diagnosis of post stroke depression as per ICD-10 criteria at least 2 weeks after the onset of stroke.

次要结局

  • Severity of post stroke depression as per ICD 10 diagnostic criteria.(Severity of post stroke depression as per ICD 10 diagnostic criteria at least 2 weeks after the onset of stroke.)

研究者

发起方
Dr. Parinitha Maben
申办方类型
Other [Principal Investigator]
责任方
Principal Investigator
主要研究者

Dr Parinitha Maben

Father Muller Medical College & Hospital

研究点 (1)

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