Validation of a Community Worker Administered Stroke Symptom Questionnaire

Completed

• Conditions: Stroke

• Registration Number: NCT02073955
• Lead Sponsor: Aga Khan University

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.

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-02
• Study First Submitted: 2014-02-25
• Study First Submitted QC: 2014-02-27
• Last Update Submitted: 2014-02-27
• Study First Posted: 2014-02-28
• Last Update Posted: 2014-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 322

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validity	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.

Secondary Outcome Measures

Name	Time	Method
Feasibility	Cross sectional - All interviews within 4 weeks( CHW and Neurologists)	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

Trial Locations

Locations (1)

Community Health Center, Ibrahim Hyderi; 🇵🇰 Karachi, Sind, Pakistan