Clinical trial NCT02073955: Validation of a Community Worker Administered Stroke Symptom Questionnaire
Official title: Adaptation and Validation of a Community Worker Administered Stroke Symptom Questionnaire in a Peri-urban Pakistani Community
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: Stroke
Validation
Community Health workers
stroke symptom questionnaire
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2014-02-28
Enrollment: 322
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults (above 40 years of age) residing in Ibrahim Hyderi and willing to participate in the all components of the study

Brief 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.

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:

1. To translate and adapt a stroke symptom questionnaire for identification of stroke symptoms by community workers in a peri-urban Pakistani community
2. To validate community workers administered stroke symptom questionnaire against assessment by neurologist in a peri-urban Pakistani community
3. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

- Individuals refusing to participate in any of the two components of the study i.e. CHW interview or neurological assessment

Primary outcomes:
measure: Validity
timeFrame: Cross-sectional , All interviews within 4 Weeks ( CHW and Neurologist)
Secondary outcomes:
measure: Feasibility
timeFrame: Cross sectional - All interviews within 4 weeks( CHW and Neurologists)
Other outcomes:
measure: Prevalence of stroke symptoms
timeFrame: Cross-sectional _ All interviews within 4 weeks, by CHWS using validated questionairre
Locations:
city: Karachi
country: Pakistan
facility: Community Health Center, Ibrahim Hyderi
state: Sind
Study officials:
affiliation: AKUH
name: Ayeesha K Kamal
role: STUDY_DIRECTOR
affiliation: AKUH
name: Maria Khan
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.