StrokeNCT04521270
Financial Burden Associated With Stroke Rehabilitation
An observational study of Stroke, run by Riphah International University at 2 sites in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Stroke
- How many people
- 80 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Jul 2020to 1 Jan 2021
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Stroke diagnosed by computerized axial tomography or a magnetic resonance imaging scan.
- Willing to give Informed consent
- Discharged from a rehabilitation hospital
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Riphah International University
Lahore, Punjab Province, 54000
Riphah Rehabiliation Clinic
Lahore, Punjab Province, 54770
About this study
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.
Read the 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.
- Conditions
- Stroke
- Keywords
- Financial Burden, Stroke, Longitudinal
- Medical subject headings
- Stroke, Financial Stress
What is being measured
The primary outcome is the main question the study is designed to answer.
Structured Questionnaire
A questionnaire that consisted of three sections:
- the patient's sociodemographic data (i.e. age, gender, ethnicity, marital status, employment status, education level and income level), and the caregiver's job, education level and income level;
- stroke characteristics, including type of stroke (i.e. ischaemic or haemorrhagic), severity of stroke (measured using the National Institute of Health Stroke Scale [NIHSS]), length of hospital stay and stroke risk factors
- stroke-related costs incurred by the patients. The family members of the patients were interviewed three times within the first three months following stroke, and the costs were averaged for analysis.
Measured: 6 Months
Secondary outcomes (2)
Modified Charlson Co-morbidity Index
The use of comorbidities for prognostic assessment has been extensively studied in other fields of medicine. One of the most commonly used comorbidity models is the Charlson Comorbidity Index (CCI), which is based on comorbid conditions with varying assigned weights, resulting in a composite score.
Measured: 6 Months
Barthel Index (BI)
The Barthel Scale/Index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL). Ten variables describing ADL and mobility are scored, a higher number being a reflection of greater ability to function independently following hospital discharge.Time taken and physical assistance required to perform each item are used in determining the assigned value of each item. The Barthel Index measures the degree of assistance required by an individual on 10 items of mobility and self care ADL
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start1 Jul 2020
- Primary completion1 Nov 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Danish Hassan, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04521270
- Sponsor's protocol ID
- REC/Lhr/20/2028 Rimsha Tariq
- Status last verified
- Mar 2021
- First submitted
- 18 Aug 2020
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Feigin VL, Krishnamurthi RV, Parmar P, Norrving B, Mensah GA, Bennett DA, Barker-Collo S, Moran AE, Sacco RL, Truelsen T, Davis S, Pandian JD, Naghavi M, Forouzanfar MH, Nguyen G, Johnson CO, Vos T, Meretoja A, Murray CJ, Roth GA; GBD 2013 Writing Group; GBD 2013 Stroke Panel Experts Group. Update on the Global Burden of Ischemic and Hemorrhagic Stroke in 1990-2013: The GBD 2013 Study. Neuroepidemiology. 2015;45(3):161-76. doi: 10.1159/000441085. Epub 2015 Oct 28.
PubMed 26505981Luengo-Fernandez R, Paul NL, Gray AM, Pendlebury ST, Bull LM, Welch SJ, Cuthbertson FC, Rothwell PM; Oxford Vascular Study. Population-based study of disability and institutionalization after transient ischemic attack and stroke: 10-year results of the Oxford Vascular Study. Stroke. 2013 Oct;44(10):2854-61. doi: 10.1161/STROKEAHA.113.001584. Epub 2013 Aug 6.
PubMed 23920019Luengo-Fernandez R, Gray AM, Rothwell PM; Oxford Vascular Study. A population-based study of hospital care costs during 5 years after transient ischemic attack and stroke. Stroke. 2012 Dec;43(12):3343-51. doi: 10.1161/STROKEAHA.112.667204. Epub 2012 Nov 15.
PubMed 23160884Tyagi S, Koh GC, Nan L, Tan KB, Hoenig H, Matchar DB, Yoong J, Finkelstein EA, Lee KE, Venketasubramanian N, Menon E, Chan KM, De Silva DA, Yap P, Tan BY, Chew E, Young SH, Ng YS, Tu TM, Ang YH, Kong KH, Singh R, Merchant RA, Chang HM, Yeo TT, Ning C, Cheong A, Ng YL, Tan CS. Healthcare utilization and cost trajectories post-stroke: role of caregiver and stroke factors. BMC Health Serv Res. 2018 Nov 22;18(1):881. doi: 10.1186/s12913-018-3696-3.
PubMed 30466417Luengo-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.
PubMed 22568484
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Financial Burden Associated With Stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT04521270
- Acronym / sponsor ID
- REC/Lhr/20/2028 Rimsha Tariq
- Conditions
- Stroke
- Keywords
- Financial Burden, Stroke, Longitudinal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 20 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Stroke diagnosed by computerized axial tomography or a magnetic resonance imaging scan.
- Willing to give Informed consent
- Discharged from a rehabilitation hospital
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Structured Questionnaire
Time frame: 6 Months
A questionnaire that consisted of three sections: 1. the patient's sociodemographic data (i.e. age, gender, ethnicity, marital status, employment status, education level and income level), and the caregiver's job, education level and income level; 2. stroke characteristics, including type of stroke (i.e. ischaemic or haemorrhagic), severity of stroke (measured using the National Institute of Health Stroke Scale [NIHSS]), length of hospital stay and stroke risk factors 3. stroke-related costs incurred by the patients. The family members of the patients were interviewed three times within the first three months following stroke, and the costs were averaged for analysis.
2 secondary outcomes
Modified Charlson Co-morbidity Index
Time frame: 6 Months
Barthel Index (BI)
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Background: PubMed 26505981Feigin VL, Krishnamurthi RV, Parmar P, Norrving B, Mensah GA, Bennett DA, Barker-Collo S, Moran AE, Sacco RL, Truelsen T, Davis S, Pandian JD, Naghavi M, Forouzanfar MH, Nguyen G, Johnson CO, Vos T, Meretoja A, Murray CJ, Roth GA; GBD 2013 Writing Group; GBD 2013 Stroke Panel Experts Group. Update on the Global Burden of Ischemic and Hemorrhagic Stroke in 1990-2013: The GBD 2013 Study. Neuroepidemiology. 2015;45(3):161-76. doi: 10.1159/000441085. Epub 2015 Oct 28.
- Background: PubMed 23920019Luengo-Fernandez R, Paul NL, Gray AM, Pendlebury ST, Bull LM, Welch SJ, Cuthbertson FC, Rothwell PM; Oxford Vascular Study. Population-based study of disability and institutionalization after transient ischemic attack and stroke: 10-year results of the Oxford Vascular Study. Stroke. 2013 Oct;44(10):2854-61. doi: 10.1161/STROKEAHA.113.001584. Epub 2013 Aug 6.
- Background: PubMed 23160884Luengo-Fernandez R, Gray AM, Rothwell PM; Oxford Vascular Study. A population-based study of hospital care costs during 5 years after transient ischemic attack and stroke. Stroke. 2012 Dec;43(12):3343-51. doi: 10.1161/STROKEAHA.112.667204. Epub 2012 Nov 15.
- Background: PubMed 30466417Tyagi S, Koh GC, Nan L, Tan KB, Hoenig H, Matchar DB, Yoong J, Finkelstein EA, Lee KE, Venketasubramanian N, Menon E, Chan KM, De Silva DA, Yap P, Tan BY, Chew E, Young SH, Ng YS, Tu TM, Ang YH, Kong KH, Singh R, Merchant RA, Chang HM, Yeo TT, Ning C, Cheong A, Ng YL, Tan CS. Healthcare utilization and cost trajectories post-stroke: role of caregiver and stroke factors. BMC Health Serv Res. 2018 Nov 22;18(1):881. doi: 10.1186/s12913-018-3696-3.
- Background: PubMed 22568484Luengo-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danish Hassan, PhD* principal investigator
Riphah International University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Riphah International University at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structured Questionnaire (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04521270, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.