Validation of a Community Worker Administered Stroke Symptom Questionnaire

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.

Study Overview

• Status: Completed
• Conditions: Stroke

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.

• Study Type: Observational
• Enrollment (Actual): 322

Contacts and Locations

Study Locations

• Pakistan
  • Sind
    • Karachi, Sind, Pakistan
      • Community Health Center, Ibrahim Hyderi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Pakistani adults; Men and women aged 40 and above, residing in Ibrahim Hyderi (periurban Pakistani community) Consenting to Interview about stroke symptoms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Cross-sectional , All interviews within 4 Weeks ( CHW and Neurologist)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Cross sectional - All interviews within 4 weeks( CHW and Neurologists)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of stroke symptoms	Once validated, we used the CHW administered tool to assess stroke symptom prevalence in this community	Cross-sectional _ All interviews within 4 weeks, by CHWS using validated questionairre

Collaborators and Investigators

• Sponsor: Aga Khan University
• Investigators: Study Director: Ayeesha K Kamal, AKUH; Principal Investigator: Maria Khan, AKUH

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: February 25, 2014
• First Submitted That Met QC Criteria: February 27, 2014
• First Posted (Estimate): February 28, 2014

Study Record Updates

• Last Update Posted (Estimate): February 28, 2014
• Last Update Submitted That Met QC Criteria: February 27, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Validation; Stroke; Community Health workers; stroke symptom questionnaire
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 5D43TW008660-02 (U.S. NIH Grant/Contract)