Clinical trial NCT06288269: Factors of Control Hypertension or Type 2 Diabetes on the Severity of Stroke and Survival Rates Within 1 Year in Trat
Official title: Factors of Control Hypertension or Non-insulin-dependent Diabetes Mellitus Type 2 on the Severity of Stroke and Survival Rates Within 1 Year in Trat Province.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Hypertension
Type2diabetes
Keywords: National Institute of Health Stroke Scale
Lead sponsor: Phrapokklao Hospital,Thailand
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 291
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A sample group of people who have had a stroke in fiscal year 2022 of people living in Trat Province. From the medical records center of Trat Hospital that received a diagnosis of stroke and were admitted to the hospital, a total of 729 cases were taken into the study process with criteria for selecting research participants (Inclusion criteria) and criteria. Exclusion criteria resulted in 291 patients who met the aforementioned criteria. There were 244 patients with hypertension as a comorbidity, 129 patients with type 2 diabetes as a comorbidity, and 100 patients with hypertension and type 2 diabetes as a comorbidity.

Brief summary: The purpose of this study was to study factors for controlling hypertension or type 2 diabetes before stroke diagnosis on the severity level when a stroke occurs, NIHSS, and survival rate after having a stroke in 1 year in Trat Province The research hypothesis was patients with hypertension or type 2 diabetes who are well-controlled Will have a lower NIHSS score than the group whose disease is not well-controlled. and patients with hypertension or type 2 diabetes that is well controlled There will be a higher survival rate for patients diagnosed with cerebrovascular disease within 1 year than those whose disease cannot be controlled.

Detailed description: BACKGROUND: Situation of Non-communicable disease groups. It was the number one health problem in the world. The situation in Thailand from 2017-2022 found an increase in the number of new diagnoses and death cases from stroke patients. For the situation in Trat Province, it was found that the situation of sickness rates tend to be stable. As for the death rate per 100,000 people from stroke, there was a continuous upward trend. Therefore, a research project was organized to study the factors of control disease (hypertension or non-insulin-dependent diabetes mellitus type 2) on the severity of stroke and survival rates within 1 year to be used as information for further patient care.

OBJECTIVES: To study factors that influence the severity of stroke and correlate with survival rates within 1 year in Trat Province.

METHODS: This is a retrospective analytic cohort study. Data was collected using a Case Record Form (CRF) to record information on a total of 291 cases of hypertension and non-insulin-dependent diabetes mellitus type 2 patients who entered the stroke treatment system at Trat Hospital in the year 2022. Data were analyzed by Chi-square statistics to test the relationship of NCD control with the severity of stroke and using Kaplan-Meier Curve test hypotheses for comparing survival rates using Log-rank test statistics.

Eligibility criteria: Inclusion Criteria:

* Patients who have chronic hypertension or type 2 diabetes with a history of illness of at least 1 year before the stroke.
* Patients had a new stroke for the first time in his life, including an ischemic stroke. hemorrhagic stroke and hemorrhage in the brain
* The patient was confirmed by CT scan
* Thai nationality.

Exclusion Criteria:

* Patients diagnosed with cerebrovascular disease who have a previous history of ischemic or hemorrhagic stroke.
* Patients diagnosed with transient ischemic attack
* Patients who have a history of chronic disease that are at high risk of having a stroke, such as being a pregnant patient, still taking birth control pills.
* There are certain genetic diseases, such as antiphospholipid syndrome
* Patients had previous history of brain aneurysm, extracranial arterial dissection, atrial fibrillation, drug addict use, etc.

Primary outcomes:
measure: Stroke severity was assessed using the National Institute of Health Stroke Scale (Clinical Mild NIHSS = 0-4 and Clinical Moderate to severe NIHSS = 5-42)
timeFrame: Results of controlling diabetes and hypertension in the 1-3 year period before having a stroke.
measure: 1 year survival death
timeFrame: 1 year after stroke attack
Secondary outcomes:
Other outcomes:
Locations:
city: Trat
country: Thailand
facility: Trat Provincial Public Health Office
Study officials:
affiliation: Trat Provincial Public Health Office
name: Panuwat Soponlertpong
role: PRINCIPAL_INVESTIGATOR
References:
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