Clinical trial NCT04521270: Financial Burden Associated With Stroke Rehabilitation
Official title: Financial Burden Associated With Stroke Rehabilitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: Financial Burden
Stroke
Longitudinal
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2020-08-20
Enrollment: 80
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were hospitalised within 72 hours of the onset of a first-ever stroke (ischaemic or haemorrhagic), as defined by the World Health Organization (WHO) underwent outpatient rehabilitation in UMMC, and had a caregiver were eligible for inclusion in the present study. Patients were excluded from the study if they were pre-morbidly dependent and/or had subarachnoid haemorrhage, transient ischaemic attack, epilepsy, psychiatric illness or any terminal illness that could affect their daily function and activities.

Brief summary: Stroke is one of the main causes of disability and the fourth leading cause of death. All over the world, stroke prevalence varies between 1.9% and 4.3%among adults older than 20 years. The incidence of a stroke increases rapidly with age, double every decade after 55 years old. After a stroke, survivors may experience several issues (i.e. rehabilitation) that increase their direct costs. Stroke survivors and their families may face considerable stroke-related financial burden. To evaluate the total amount or costs use for formal and informal care and the equipment or materials needed for care. This study will be conducted to evaluate the Financial Burden associated with stroke Survivors rehabilitation during their first post stroke year and to analyze the basic predictors of these financial expenses. Data will be collected from Sheikh Zayed hospital Lahore. A cross sectional Longitudinal study will be conducted. The Study will be conducted within 6 months of time period. Post stroke patients who discharge from hospital, after this disease had directly impacts on the survivors' and their family's lives and requires a long rehabilitation process, so they faces many challenges which will be studied. The Barthel Index Scale and Modified Charlson Co-morbidity Index is used to examine the participants autonomy in everyday life activities and their co-morbidities were administered in Stroke Survivors. Stroke Survivors who willing to participate will join in this study and the signed informed consent form will be taken from all participants. After getting approval from research committee data will be collected from the participants and SPSS V 25 will be used for data entry and analysis. The results of this study will help to explore the total amount of cost which use in stroke survivors rehabilitation process.

Detailed description: Stroke is a clinical syndrome characterized by the rapid onset of focal neurological signs, lasting more than 24 hours or leading to death, with a presumed vascular cause. The main causes of stroke is it occur due to infarction and due to hemorrhage. In the U.S, approximately 40 percent of people who die from stroke are male, with 60 percent of deaths occurring in females. Worldwide, cerebro-vascular accidents (stroke) are the second leading cause of death and the third leading cause of disability. Stroke, the sudden death of some brain cells due to lack of oxygen when the blood flow to the brain is lost by blockage or rupture of an artery to the brain, is also a leading cause of dementia and depression. Globally, 70% of strokes and 87% of both stroke-related deaths and disability-adjusted life years occur in low- and middle-income countries. Over the last four decades, the stroke incidence in low- and middle-income countries has more than doubled. During these decades stroke incidence has declined by 42% in high-income countries.

The incidence of a stroke increases rapidly with age, doubling every decade after 55 years old. There are various risk factors for stroke, including both modifiable (e.g., diet, co-morbid conditions) and non-modifiable risk factors (e.g., age, race).Other risk factors which is short-term risks or triggers (e.g., infectious events, sepsis, stress), intermediate- term risk factors (e.g., hypertension, hyperlipidemia) and long-term risk factors for stroke (e.g., sex, race). Risk factors for stroke in the young also likely differ from those in older patients. Recovery and rehabilitation is the most important aspects of stroke treatment. In most strokes cases the patient recover quickly, and sometimes patient recovery is variable. Rehabilitation process includes physical therapy, speech therapy and occupational therapy. Physical therapy involves using exercise and other physical means (e.g., massage, heat) and may help patients to regain their ROM and use of their arms and legs and prevent muscle stiffness in patients or with permanent paralysis. Speech therapy may help patients regain the ability to speak. Occupational therapy may help patients regain independent function and re-learn basic skills (e.g., Getting dressed, preparing a meal and bathing). Stroke is a common, serious, and disabling global health-care problem, and rehabilitation is a major part of patient care.Potentially beneficial treatment options for motor recovery of the arm include constraint-induced movement therapy and robotics. Most favorable interventions that could be beneficial to improve aspects of gait include fitness training, high-intensity therapy, and repetitive-task training.

Eligibility criteria: Inclusion Criteria:

* Stroke diagnosed by computerized axial tomography or a magnetic resonance imaging scan.
* Willing to give Informed consent
* Discharged from a rehabilitation hospital

Exclusion Criteria:

* Pre existing Physical or Psychiatric disabilities ( e.g. , Dementia, Multiple Sclerosis, Parkinson's Disease)
* Previous Stroke or Aphasia
* A patient with Reduced level of Consciousness

Primary outcomes:
measure: Structured Questionnaire
timeFrame: 6 Months
Secondary outcomes:
measure: Modified Charlson Co-morbidity Index
timeFrame: 6 Months
measure: Barthel Index (BI)
timeFrame: 6 Months
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah International University
state: Punjab
city: Lahore
country: Pakistan
facility: Riphah Rehabiliation Clinic
state: Punjab
Study officials:
affiliation: Riphah International University
name: Danish Hassan, PhD*
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Luengo-Fernandez R, Yiin GS, Gray AM, Rothwell PM. Population-based study of acute- and long-term care costs after stroke in patients with AF. Int J Stroke. 2013 Jul;8(5):308-14. doi: 10.1111/j.1747-4949.2012.00812.x. Epub 2012 May 9.