NCT04521270

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

4 months

First QC Date

August 18, 2020

Last Update Submit

March 26, 2021

Conditions

Keywords

Financial BurdenStrokeLongitudinal

Outcome Measures

Primary Outcomes (1)

  • Structured Questionnaire

    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.

    6 Months

Secondary Outcomes (2)

  • Modified Charlson Co-morbidity Index

    6 Months

  • Barthel Index (BI)

    6 Months

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

Location

Riphah Rehabiliation Clinic

Lahore, Punjab Province, 54770, Pakistan

Location

Related Publications (5)

  • 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.

    PMID: 26505981BACKGROUND
  • Luengo-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.

    PMID: 23920019BACKGROUND
  • Luengo-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.

    PMID: 23160884BACKGROUND
  • Tyagi 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.

    PMID: 30466417BACKGROUND
  • 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.

    PMID: 22568484BACKGROUND

MeSH Terms

Conditions

StrokeFinancial Stress

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Danish Hassan, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2020

First Posted

August 20, 2020

Study Start

July 1, 2020

Primary Completion

November 1, 2020

Study Completion

January 1, 2021

Last Updated

April 1, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations