Cerebrovascular DiseaseNCT02351778
Quality of Life of Stable Stroke Survivors in Pakistan
An observational study of Cerebrovascular Disease, run by Aga Khan University.
Trial summary
In study the investigators sought to 1. Assess the quality of life experience in stable post stroke survivors in Pakistan and detail important factors influencing quality of life. 2. Explore the association between primary care giver's quality of life and stroke survivor's quality of life. 3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Disease
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jun 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All men and women greater than 18 years, with a chronic stable stroke, medically confirmed supported by medical reports or radiological and neurological diagnosis and with an identified primary care giver.
Who may be able to join
- All men and women of age greater than 18 years of age with medically confirmed diagnosis of stroke.
- Suffered stroke (3 months till 12 months), stable non fluctuating stroke which means no acute ongoing neurologic developments (Crescendo TIA, CEA planned, intervention needed, progressing stroke, fluctuating unexplained neurologic symptoms).
- With an identified primary care giver (This is a person who lives with the stroke patient, is familiar with the medical history and provides direct care e.g. feeding support, medication reminders, rehab. This person may be different from the legal surrogate e.g., son vs. daughter in law )
Who cannot join
- Post procedure stroke like CABG, angiography, post-operative.
- Global aphasia with failure to communicate (NIHSS greater than 23).
- Dementia with failure to communicate (Minimental state of 22)
- With history of psychoactive substance abuse.
- Psychiatric morbidity like schizophrenia and other manic disorders.
- Suffering from chronic disease like terminal stage cancer and end stage renal disease.
About this study
Official title: Quality of Life of Stable Stroke Survivors and Their Caregivers in an Low and Middle Income Country
In study the investigators sought to
- Assess the quality of life experience in stable post stroke survivors in Pakistan and detail important factors influencing quality of life.
- Explore the association between primary care giver's quality of life and stroke survivor's quality of life.
- To validate the quality of life tools and experience via in depth interviews and focus group discussion with the primary care giver of stroke patients to report the quality of life of the primary care giver.
Read the detailed description
Disability caused by stroke has a detrimental impact on patients with social and physical consequences of stroke being equally devastating. Yet there are only few studies done in South Asia that explore holistically the cumulative impact of disability and quality of life on stroke survivors.
In Pakistan majority of stroke patients are cared by close family members and no inpatient rehabilitation services are available in Pakistan for stroke survivors. The amount of support from government is scarce and private systems are largely unregulated therefore the psychosocial problems in Pakistani stroke survivors are different from those experienced by stroke survivors in developed countries. It is proposed that the quality of life of stroke survivors in Pakistan will be worse as compared to stroke survivors in developed countries. However, due to existence of considerable family support even in absence of good government and environmental support systems we cannot be certain about this assumption. Since care givers provide all medical and social services to chronic stroke victims their quality of life and stress level also plays an important role in the care given to the stroke survivors.
We propose to conduct a cross-sectional study, in order to assess the quality of life in stroke survivors and its important predictors in Karachi. The domains which will be studied includes physical; in terms of severity of disability, which affects the person after stroke, social functioning; which includes the role of primary care giver and social support given to the stroke survivors, mental health; in which depression affects the life of stroke survivor badly after stroke.
Also to explore the perspective of the primary care giver for those important factors which affect the quality of life focus group discussions will be conducted in the study. This is a mixed methods observational analytical study.
- Conditions
- Cerebrovascular Disease
- Keywords
- Developing Countries, Quality of Life, Mixed Methods, Validation, Caregiver Burden
- Medical subject headings
- Cerebrovascular Disorders, Caregiver Burden
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life of stroke survivors evaluated by stroke specific quality of life scale one month post stroke
Stroke Specific Quality of Life Scale
Measured: 12 Months
Secondary outcomes (1)
Quality of life of primary care givers of stroke survivors evaluated by RAND-36
RAND- 36 Quality of Life in Primary Caregivers
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study startJan 2014
- Primary completionMay 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular DiseaseStudies of the same condition, open and under way.
- 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
- Time perspective
- Cross-sectional
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ayeesha Kamran Kamal, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02351778
- Sponsor's protocol ID
- 5D43TW008660-04
- Status last verified
- Jan 2015
- First submitted
- 28 Jan 2015
- Last updated
- 30 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Khalid W, Rozi S, Ali TS, Azam I, Mullen MT, Illyas S, Un-Nisa Q, Soomro N, Kamal AK. Quality of life after stroke in Pakistan. BMC Neurol. 2016 Dec 3;16(1):250. doi: 10.1186/s12883-016-0774-1.
PubMed 27912744
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life of Stable Stroke Survivors and Their Caregivers in an Low and Middle Income Country
- ClinicalTrials.gov ID
- NCT02351778
- Acronym / sponsor ID
- 5D43TW008660-04
- Conditions
- Cerebrovascular Disease
- Keywords
- Developing Countries, Quality of Life, Mixed Methods, Validation, Caregiver Burden
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 30 Jan 2015 (estimated)
- 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.
In study the investigators sought to
- Assess the quality of life experience in stable post stroke survivors in Pakistan and detail important factors influencing quality of life.
- Explore the association between primary care giver's quality of life and stroke survivor's quality of life.
- To validate the quality of life tools and experience via in depth interviews and focus group discussion with the primary care giver of stroke patients to report the quality of life of the primary care giver.
Detailed description
Disability caused by stroke has a detrimental impact on patients with social and physical consequences of stroke being equally devastating. Yet there are only few studies done in South Asia that explore holistically the cumulative impact of disability and quality of life on stroke survivors.
In Pakistan majority of stroke patients are cared by close family members and no inpatient rehabilitation services are available in Pakistan for stroke survivors. The amount of support from government is scarce and private systems are largely unregulated therefore the psychosocial problems in Pakistani stroke survivors are different from those experienced by stroke survivors in developed countries. It is proposed that the quality of life of stroke survivors in Pakistan will be worse as compared to stroke survivors in developed countries. However, due to existence of considerable family support even in absence of good government and environmental support systems we cannot be certain about this assumption. Since care givers provide all medical and social services to chronic stroke victims their quality of life and stress level also plays an important role in the care given to the stroke survivors.
We propose to conduct a cross-sectional study, in order to assess the quality of life in stroke survivors and its important predictors in Karachi. The domains which will be studied includes physical; in terms of severity of disability, which affects the person after stroke, social functioning; which includes the role of primary care giver and social support given to the stroke survivors, mental health; in which depression affects the life of stroke survivor badly after stroke.
Also to explore the perspective of the primary care giver for those important factors which affect the quality of life focus group discussions will be conducted in the study. This is a mixed methods observational analytical study.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All men and women greater than 18 years, with a chronic stable stroke, medically confirmed supported by medical reports or radiological and neurological diagnosis and with an identified primary care giver.
Key inclusion criteria (3 listed)
- All men and women of age greater than 18 years of age with medically confirmed diagnosis of stroke.
- Suffered stroke (3 months till 12 months), stable non fluctuating stroke which means no acute ongoing neurologic developments (Crescendo TIA, CEA planned, intervention needed, progressing stroke, fluctuating unexplained neurologic symptoms).
- With an identified primary care giver (This is a person who lives with the stroke patient, is familiar with the medical history and provides direct care e.g. feeding support, medication reminders, rehab. This person may be different from the legal surrogate e.g., son vs. daughter in law )
Key exclusion criteria (6 listed)
- Post procedure stroke like CABG, angiography, post-operative.
- Global aphasia with failure to communicate (NIHSS greater than 23).
- Dementia with failure to communicate (Minimental state of 22)
- With history of psychoactive substance abuse.
- Psychiatric morbidity like schizophrenia and other manic disorders.
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
Quality of life of stroke survivors evaluated by stroke specific quality of life scale one month post stroke
Time frame: 12 Months
Stroke Specific Quality of Life Scale
1 secondary outcome
Quality of life of primary care givers of stroke survivors evaluated by RAND-36
Time frame: 12 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 30 Jan 2015.
- Derived from this study: PubMed 27912744Khalid W, Rozi S, Ali TS, Azam I, Mullen MT, Illyas S, Un-Nisa Q, Soomro N, Kamal AK. Quality of life after stroke in Pakistan. BMC Neurol. 2016 Dec 3;16(1):250. doi: 10.1186/s12883-016-0774-1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Disease, run by Aga Khan University.
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 6 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 30 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Quality of life of stroke survivors evaluated by stroke specific quality of life scale one month post stroke (time frame: 12 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 NCT02351778, which also lists 1 linked publication.
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 30 Jan 2015.