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

• Conditions: Lower Respiratory System Conditions; ENT Conditions; Mental Health Conditions; Orthopedic Conditions; Genitourinary System Conditions; Abdominal Pain/Gastrointestinal Issues; Upper Respiratory System Conditions; Ophthalmology Conditions; Dermatology Conditions; Cardiovascular System Conditions
• Interventions: Device: Ada Waiting Room App (WRA) and Ada Diagnostic Support Application (HDA)

• Registration Number: NCT04958577
• Lead Sponsor: Ada Health GmbH

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-06-30
• Study First Submitted QC: 2021-07-09
• Study First Posted: 2021-07-12
• Study Start: 2021-08-03
• Primary Completion: 2021-12-17
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-17
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 109

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Wing B (Ada HDA)	Ada Waiting Room App (WRA) and Ada Diagnostic Support Application (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.
Wing A (Ada WRA)	Ada Waiting Room App (WRA) and Ada Diagnostic Support Application (HDA)	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.

Primary Outcome Measures

Name	Time	Method
Accuracy and Comprehensiveness measures of Ada WRA and HDA	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.

Secondary Outcome Measures

Name	Time	Method
Urgency advice accuracy	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.
Questionnaire data insights	through study completion, an average of 4 months	Qualitative data on the usability, usefulness and acceptance of the SAA
Comparison of usual care doctor condition suggestions	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.

Trial Locations

Locations (1)

Mbagala Rangi Tatu Hospital; 🇹🇿 Dar Es Salaam, Tanzania