Validation of a Community Worker Administered Stroke Symptom Questionnaire

Stroke Clinical Trial

Official title:

Adaptation and Validation of a Community Worker Administered Stroke Symptom Questionnaire in a Peri-urban Pakistani Community

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02073955
• Other study ID #: 5D43TW008660-02
• Status: Completed
• Phase: N/A
• First received: February 25, 2014
• Last updated: February 27, 2014
• Start date: March 2013
• Est. completion date: June 2013

Study information

• Verified date: February 2014
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Research Ethics Committee
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 322
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Stroke

Locations

Country	Name	City	State
Pakistan	Community Health Center, Ibrahim Hyderi	Karachi	Sind

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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)	No
Secondary	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)	No