Abdominal Pain/Gastrointestinal IssuesAFYANCT04958577
Clinic Waiting Room-based Study of Swahili Language Artificial Intelligence-driven Symptom Assessments in Tanzanian Primary Health Care Facilities
An observational study of Abdominal Pain/Gastrointestinal Issues and Lower Respiratory System Conditions, run by Ada Health GmbH at 1 site in Tanzania.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 months and older
- Conditions the study is for
- Abdominal Pain/Gastrointestinal Issues, Lower Respiratory System Conditions, Upper Respiratory System Conditions
- What is being tested?
- Ada Waiting Room App (WRA) and Ada Diagnostic Support Application (HDA)
- Type of treatment
- Medical device
- How many people
- 109 participants
- Where
- 1 siteTanzania
- Study dates
- 3 Aug 2021to 1 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Abdominal Pain/Gastrointestinal Issues, Lower Respiratory System Conditions, Upper Respiratory System Conditions, Mental Health Conditions, Ophthalmology Conditions, Orthopedic Conditions
- Being tested
- Ada Waiting Room App (WRA) and Ada Diagnostic Support Application (HDA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ada Waiting Room App (WRA) and Ada Diagnostic Support Application (HDA)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Ada Waiting Room App (WRA) and Ada Diagnostic Support Application (HDA) | |
| 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. Receives: Device: Ada Waiting Room App (WRA) and Ada Diagnostic Support Application (HDA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy and Comprehensiveness measures of Ada WRA and HDA
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.
Measured: through study completion, an average of 4 months
Secondary outcomes (3)
Comparison of usual care doctor condition suggestions
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.
Measured: through study completion, an average of 4 months
Urgency advice accuracy
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.
Measured: through study completion, an average of 4 months
Questionnaire data insights
Qualitative data on the usability, usefulness and acceptance of the SAA
Measured: through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start3 Aug 2021
- Primary completion17 Dec 2021
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Abdominal Pain/Gastrointestinal IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ada Health GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Muhimbili University of Health and Allied Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04958577
- Sponsor's protocol ID
- AFYA
- Acronym
- AFYA
- Status last verified
- May 2022
- First submitted
- 30 Jun 2021
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35671073Millen 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.
PubMed 35410928
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinic Waiting Room-based Pilot of Swahili Language Artificial Intelligence-driven Symptom Assessments in Primary Health Care Facilities, Dar es Salaam, Tanzania
- ClinicalTrials.gov ID
- NCT04958577
- Acronym / sponsor ID
- AFYA / AFYA
- Conditions
- Abdominal Pain/Gastrointestinal Issues, Lower Respiratory System Conditions, Upper Respiratory System Conditions, Mental Health Conditions, Ophthalmology Conditions, Orthopedic Conditions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Ada Health GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Muhimbili University of Health and Allied Sciences
- Study start
- 3 Aug 2021 (actual)
- Primary completion
- 17 Dec 2021 (actual)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 12 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wing A (Ada WRA) | – | Device: 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. |
| Wing B (Ada HDA) | – | Device: 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. |
Who may qualify
- Ages
- 2 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Wing A (Ada WRA), Wing B (Ada HDA) |
Primary outcome
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.
3 secondary outcomes
Comparison of usual care doctor condition suggestions
Time frame: through study completion, an average of 4 months
Urgency advice accuracy
Time frame: through study completion, an average of 4 months
Questionnaire data insights
Time frame: through study completion, an average of 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Derived from this study: PubMed 35671073Schmude 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.
- Derived from this study: PubMed 35410928Millen 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Pain/Gastrointestinal Issues and Lower Respiratory System Conditions, run by Ada Health GmbH at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy and Comprehensiveness measures of Ada WRA and HDA (time frame: through study completion, an average of 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04958577, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.