Clinic Waiting Room-based Study of Swahili Language Artificial Intelligence-driven Symptom Assessments in Tanzanian Primary Health Care Facilities (AFYA)

May 16, 2022 updated by: Ada Health GmbH

Clinic Waiting Room-based Pilot of Swahili Language Artificial Intelligence-driven Symptom Assessments in Primary Health Care Facilities, Dar es Salaam, Tanzania

This study will evaluate the accuracy of the condition suggestions and urgency advice of the Swahili language Ada symptom assessment application (SAA), when symptoms are input by a lay-person user and a medical professional; these SAA results will then be compared to the condition suggestions and urgency advice of different tiers of doctors and a "gold standard" created by a panel.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

There will be two different wings of this study: (1) where a lay-person inputs their symptoms into the Swahili language Ada symptom assessment application (SAA); (2) where the usual care doctor asks a lay-person (the patient) the same questions from the SAA and determines their own condition suggestions based off this questioning and the SAA's condition suggestions. In both wings, the patient will be seeing their usual care doctor for a diagnosis and then a study-provided physician for a diagnosis. Separately, the doctors will list a ranking of other considered condition suggestions (diagnoses) and urgency advice, which will not be shared with the patient. These condition suggestions and urgency advice will be compared to a "gold standard", which will be determined by a high level panel for each patient's case, based on the doctor notes and physical examination results of each patient's visit.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
109

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tanzania
      • Dar Es Salaam, Tanzania
        • Mbagala Rangi Tatu Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients will only be included if they are waiting in the clinic waiting room of the hospital where this study will take place. Inclusion of patients will be monitored throughout the study in order to ensure recruitment of a study sample of patients with a comprehensive spectrum of symptoms constellations and conditions: this is to ensure that this pilot study tests the performance of SAA on a broad range of scenarios. Study recruitment will be carried out to a target of enrolling between 2-5 patients for 10 different body system categories (including at least one adult and one child in each category).

Description

Inclusion Criteria:

  • All patients who enter the clinic and that are willing/able to provide consent will be included, except those who fall under certain conditions listed below

Exclusion Criteria:

  • Patients with severe injury/illness requiring immediate treatment
  • Patients with traumatic injury (many of these patients require minimal anamnesis, and it is not rational to include them in a pilot study)
  • Patients incapable of completing a health assessment (e.g. due to illiteracy, mental impairment or inebriation or other incapacity).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Wing A (Ada WRA)
Patients in this group will be filling out the Ada assessment themselves and then heading to a normal consultation by first the usual care doctor and then the study-provided physician.
Device: Ada Waiting Room App (WRA) and Ada Diagnostic Support Application (HDA)
This device is a medical device but will be used only observationally--this device takes a patient's symptoms into account by asking questions and gives a ranked list of likely conditions that the patient might have based on the answers to these questions. The assessment report also includes urgency advice levels, that is, which care the patient should proceed to based on the condition suggestions. The WRA is used by the patient directly and the HDA is used by the doctor to ask the questions to the patient.
Wing B (Ada HDA)
Patients in this group will be asked questions from the Ada assessment by a health care practitioner and then heading to a normal consultation by first the usual care doctor and then the study-provided physician.
Device: Ada Waiting Room App (WRA) and Ada Diagnostic Support Application (HDA)
This device is a medical device but will be used only observationally--this device takes a patient's symptoms into account by asking questions and gives a ranked list of likely conditions that the patient might have based on the answers to these questions. The assessment report also includes urgency advice levels, that is, which care the patient should proceed to based on the condition suggestions. The WRA is used by the patient directly and the HDA is used by the doctor to ask the questions to the patient.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Accuracy and Comprehensiveness measures of Ada WRA and HDA
Time Frame: through study completion, an average of 4 months
The condition-suggestion accuracy and comprehensiveness of the SAA, evaluated against the gold-standard differential diagnosis determined by the review panel, reported in the context of the accuracy of the usual care health practitioner.
through study completion, an average of 4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Comparison of usual care doctor condition suggestions
Time Frame: through study completion, an average of 4 months
In Wing B only, while using the Ada HDA, the difference between the usual care doctor's condition suggestion accuracy and urgency advice will be compared between (1) the study arm where they determine a ranked list of condition suggestions before seeing Ada's list and then will choose a new ranked list based on viewing Ada's list, and (2) the study arm where after using the HDA, the doctor will see Ada's ranked list of condition suggestions and then choose to use Ada's full list or add some condition suggestions of their own. The accuracy of these will then also be compared to the study-provided physician and the gold standard panel.
through study completion, an average of 4 months
Urgency advice accuracy
Time Frame: through study completion, an average of 4 months
The urgency advice accuracy of the SAA, evaluated against the gold-standard triage levels determined by the review panel, reported in the context of the accuracy of the usual care health practitioner.
through study completion, an average of 4 months
Questionnaire data insights
Time Frame: through study completion, an average of 4 months
Qualitative data on the usability, usefulness and acceptance of the SAA
through study completion, an average of 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ada Health GmbH

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Muhimbili University of Health and Allied Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 3, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 17, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 30, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AFYA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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