Clinical trial NCT04958577: Clinic Waiting Room-based Study of Swahili Language Artificial Intelligence-driven Symptom Assessments in Tanzanian Primary Health Care Facilities
Official title: Clinic Waiting Room-based Pilot of Swahili Language Artificial Intelligence-driven Symptom Assessments in Primary Health Care Facilities, Dar es Salaam, Tanzania
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Abdominal Pain/Gastrointestinal Issues
Lower Respiratory System Conditions
Upper Respiratory System Conditions
Mental Health Conditions
Ophthalmology Conditions
Orthopedic Conditions
Cardiovascular System Conditions
Genitourinary System Conditions
ENT Conditions
Dermatology Conditions
Gynecology/Obstetrics Conditions
Neurological Conditions
Lead sponsor: Ada Health GmbH
Sponsor class: INDUSTRY
Collaborators: name: Muhimbili University of Health and Allied Sciences
First posted: 2021-07-12
Enrollment: 109
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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).

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Accuracy and Comprehensiveness measures of Ada WRA and HDA
timeFrame: through study completion, an average of 4 months
Secondary outcomes:
measure: Comparison of usual care doctor condition suggestions
timeFrame: through study completion, an average of 4 months
measure: Urgency advice accuracy
timeFrame: through study completion, an average of 4 months
measure: Questionnaire data insights
timeFrame: through study completion, an average of 4 months
Other outcomes:
Locations:
city: Dar Es Salaam
country: Tanzania
facility: Mbagala Rangi Tatu Hospital
Study officials:
References:
citation: Schmude M, Salim N, Azadzoy H, Bane M, Millen E, O'Donnell L, Bode P, Turk E, Vaidya R, Gilbert S. Investigating the Potential for Clinical Decision Support in Sub-Saharan Africa With AFYA (Artificial Intelligence-Based Assessment of Health Symptoms in Tanzania): Protocol for a Prospective, Observational Pilot Study. JMIR Res Protoc. 2022 Jun 7;11(6):e34298. doi: 10.2196/34298.
citation: Millen E, Salim N, Azadzoy H, Bane MM, O'Donnell L, Schmude M, Bode P, Tuerk E, Vaidya R, Gilbert SH. Study protocol for a pilot prospective, observational study investigating the condition suggestion and urgency advice accuracy of a symptom assessment app in sub-Saharan Africa: the AFYA-'Health' Study. BMJ Open. 2022 Apr 11;12(4):e055915. doi: 10.1136/bmjopen-2021-055915.