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Completed

NCT Number: NCT02073955

Validation of a Community Worker Administered Stroke Symptom Questionnaire

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Community Health Center, Ibrahim Hyderi

Karachi, Sindh, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Feasibility

    Time frame: 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

Other outcomes

  1. Prevalence of stroke symptoms

    Time frame: Cross-sectional _ All interviews within 4 weeks, by CHWS using validated questionairre

    Once validated, we used the CHW administered tool to assess stroke symptom prevalence in this community

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 28, 2014
Registry last updated
Feb 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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