StrokeNCT02073955
Validation of a Community Worker Administered Stroke Symptom Questionnaire
An observational study of Stroke, run by Aga Khan University at 1 site in Pakistan.
Trial summary
This is a validation study. A stroke symptom questionnaire will be adapted and translated into local language. Two community health workers will be trained in its administration. Their findings will be validated against assessment by two neurologists. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Stroke
- How many people
- 322 participants
- Where
- 1 sitePakistan
- Study dates
- Mar 2013to Jun 2013
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults (above 40 years of age) residing in Ibrahim Hyderi and willing to participate in the all components of the study
Who may be able to join
- Men and women aged 40 and above
- Permanent resident of Ibrahim Hyderi
- All ethnicities
- Can answer for themselves or have a surrogate willing to provide necessary information. Surrogate is defined as one who lives in the same household as the individual, who is the primary caregiver and has access to the medical record / information of the patient.
- Willing to give written informed consent
Who cannot join
- Individuals refusing to participate in any of the two components of the study i.e. CHW interview or neurological assessment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adaptation and Validation of a Community Worker Administered Stroke Symptom Questionnaire in a Peri-urban Pakistani Community
This is a validation study. A stroke symptom questionnaire will be adapted and translated into local language. Two community health workers will be trained in its administration. Their findings will be validated against assessment by two neurologists.
The study hypothesis is that the chance corrected agreement between the community worker administered stroke symptom questionnaire and the assessment by neurologist based on history and physical examination is at least moderate.
Read the detailed description
Overall Objective: To translate, adapt and validate a stroke symptom questionnaire for identification of stroke symptoms by community health workers ( CHW) in a peri-urban Pakistani community
Specific Aims:
- To translate and adapt a stroke symptom questionnaire for identification of stroke symptoms by community workers in a peri-urban Pakistani community
- To validate community workers administered stroke symptom questionnaire against assessment by neurologist in a peri-urban Pakistani community
- To determine the feasibility of utilizing community workers for identification of stroke patients in the community in terms of subject refusals and difficulty in understanding questions
The study will be conducted at the community site of AMAN community health project in Ibrahim Hyderi. Community health workers will systematically select households and from them individuals meeting eligibility criteria will be interviewed. Community workers will administer stroke symptom questionnaire to them at their homes. Those unable to answer will have a surrogate answering for them. In the second part of the study, two neurologists will independently assess all individuals. The purpose of this would be to validate the findings of the community workers based on the stroke symptom questionnaire.
- Conditions
- Stroke
- Keywords
- Stroke, Validation, Community Health workers, stroke symptom questionnaire
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pakistani adults | Men and women aged 40 and above, residing in Ibrahim Hyderi (periurban Pakistani community) Consenting to Interview about stroke symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity
This was a validation study in which we calculated the sensitivity, specificity and predictive values for CHW administered questionnaire against assessment by two neurologists. We also assessed the chance corrected agreement (kappa) for the same.
Measured: Cross-sectional , All interviews within 4 Weeks ( CHW and Neurologist)
Secondary outcomes (1)
Feasibility
We assessed the feasibility of utilizing CHWs for stroke screening in terms of time taken to fill out questionnaire, difficulty in understanding questions and subject refusals
Measured: Cross sectional - All interviews within 4 weeks( CHW and Neurologists)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2014 (estimated)
- Study startMar 2013
- Primary completionJun 2013
- Study completionJun 2013
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 StrokeStudies 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
- 322 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
- Investigators
- Ayeesha K Kamal, Study director, AKUHMaria Khan, Principal investigator, AKUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073955
- Sponsor's protocol ID
- 5D43TW008660-02
- Status last verified
- Feb 2014
- First submitted
- 25 Feb 2014
- Last updated
- 28 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Khan M, Kamal AK, Pasha O, Islam M, Azam I, Virk A, Nasir A, Andani A, Jan M, Akhtar A, Razzak JA. Study Protocol: Validation and Adaptation of community-worker-administered stroke symptom questionnaire in a periurban Pakistani community to determine disease burden. J Vasc Interv Neurol. 2015 Feb;8(1):1-10.
PubMed 25825625
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation and Validation of a Community Worker Administered Stroke Symptom Questionnaire in a Peri-urban Pakistani Community
- ClinicalTrials.gov ID
- NCT02073955
- Acronym / sponsor ID
- 5D43TW008660-02
- Conditions
- Stroke
- Keywords
- Stroke, Validation, Community Health workers, stroke symptom questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 28 Feb 2014 (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.
This is a validation study. A stroke symptom questionnaire will be adapted and translated into local language. Two community health workers will be trained in its administration. Their findings will be validated against assessment by two neurologists.
The study hypothesis is that the chance corrected agreement between the community worker administered stroke symptom questionnaire and the assessment by neurologist based on history and physical examination is at least moderate.
Detailed description
Overall Objective: To translate, adapt and validate a stroke symptom questionnaire for identification of stroke symptoms by community health workers ( CHW) in a peri-urban Pakistani community
Specific Aims:
- To translate and adapt a stroke symptom questionnaire for identification of stroke symptoms by community workers in a peri-urban Pakistani community
- To validate community workers administered stroke symptom questionnaire against assessment by neurologist in a peri-urban Pakistani community
- To determine the feasibility of utilizing community workers for identification of stroke patients in the community in terms of subject refusals and difficulty in understanding questions
The study will be conducted at the community site of AMAN community health project in Ibrahim Hyderi. Community health workers will systematically select households and from them individuals meeting eligibility criteria will be interviewed. Community workers will administer stroke symptom questionnaire to them at their homes. Those unable to answer will have a surrogate answering for them. In the second part of the study, two neurologists will independently assess all individuals. The purpose of this would be to validate the findings of the community workers based on the stroke symptom questionnaire.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pakistani adults | – | –Men and women aged 40 and above, residing in Ibrahim Hyderi (periurban Pakistani community) Consenting to Interview about stroke symptoms |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (above 40 years of age) residing in Ibrahim Hyderi and willing to participate in the all components of the study
Key inclusion criteria (5 listed)
- Men and women aged 40 and above
- Permanent resident of Ibrahim Hyderi
- All ethnicities
- Can answer for themselves or have a surrogate willing to provide necessary information. Surrogate is defined as one who lives in the same household as the individual, who is the primary caregiver and has access to the medical record / information of the patient.
- Willing to give written informed consent
Key exclusion criteria (1 listed)
- Individuals refusing to participate in any of the two components of the study i.e. CHW interview or neurological assessment
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
Validity
Time frame: Cross-sectional , All interviews within 4 Weeks ( CHW and Neurologist)
This was a validation study in which we calculated the sensitivity, specificity and predictive values for CHW administered questionnaire against assessment by two neurologists. We also assessed the chance corrected agreement (kappa) for the same.
1 secondary outcome
Feasibility
Time frame: Cross sectional - All interviews within 4 weeks( CHW and Neurologists)
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 28 Feb 2014.
- Derived from this study: PubMed 25825625Khan M, Kamal AK, Pasha O, Islam M, Azam I, Virk A, Nasir A, Andani A, Jan M, Akhtar A, Razzak JA. Study Protocol: Validation and Adaptation of community-worker-administered stroke symptom questionnaire in a periurban Pakistani community to determine disease burden. J Vasc Interv Neurol. 2015 Feb;8(1):1-10.
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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.
Ayeesha K Kamal study director
AKUH
Maria Khan principal investigator
AKUH
1 site 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 Aga Khan University at 1 site 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 5 inclusion and 1 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 28 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Validity (time frame: Cross-sectional , All interviews within 4 Weeks ( CHW and Neurologist)). 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 NCT02073955, 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 28 Feb 2014.