A Prospective, Mixed-Methods Feasibility Study to Evaluate the Agreement, Safety, and Acceptability of 'Dora Care', an Automated AI Voice Assistant, for Supporting Clinical Pathways in a Fracture Liaison Service.
Trial ID: NCT07464171
Status: NOT_YET_RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2026-02
Completion date: 2027-12
Sponsor: Ufonia
Collaborators: University College London Hospitals; University of York
Conditions: AI (Artificial Intelligence); Osteoporosis; Outpatient; Telemedicine; Automation; Risk Assesment; Bone Health
Interventions: Dora call
Enrollment: 217
Age range: 50 Years - None
Sex: ALL

Summary:
What is the study about? This study is testing "Dora", an AI-powered assistant that can make phone calls to patients, for use in the Fracture Liaison Service (FLS). The FLS is a clinic that helps prevent more bone fractures after an initial "fragility fracture" (a break that happens easily, usually due to osteoporosis).

Why is this being done? FLS clinicians often have to spend a lot of time on routine phone calls for assessments and follow-ups. If Dora can safely and accurately collect patient information, it might save time for staff and still give patients a good experience.

What will happen to patients in the study? Invitation and consent - Patients with a new fragility fracture who are eligible will be invited to take part after informed consent.

Dora call - Patients will receive an automated phone call from Dora, at the start of their FLS pathway and at follow-up.

At intake, Dora will ask about risk factors for bone problems (e.g., smoking, alcohol use, family fracture history).

At follow-up, Dora will ask about medication use, side effects, falls, or new fractures.

Clinician call - Soon after, patients will have their usual phone appointment with an FLS clinician, who asks similar questions.

Surveys/interviews - Patients will be asked to complete a short questionnaire and take part in an optional interview to say how they felt about talking to Dora.

What about clinicians? Clinicians involved in the FLS pathway will be asked to complete a short survey and to take part in an optional interview to understand how useful Dora's reports might be in their work.

Who can take part? Patients - Age 50+, English-speaking, with a new fragility fracture, and able to use the phone.

Clinicians - Those working in FLS or similar bone health services. How long will it take? Each patient might be involved for up to about 7 months. The whole study will take about a year.

Eligibility criteria:
Inclusion Criteria:

* Access to and ability to use a telephone for automated conversations as part of a routine, FLS phone pathway. This includes patients who are:
* Adults aged ≥50 years.
* Presenting with a new fragility fracture requiring FLS assessment.
* Able to provide informed consent.
* English speaking.
* Reside in the UK.

Exclusion Criteria:

* Severe cognitive impairment precluding meaningful telephone interaction or informed consent.
* Patients already established on long-term osteoporosis treatment.
* Terminal illness with a life expectancy \<12 months.
* Current participation in another clinical trial altering standard of care thus altering the care schedule.

Outcomes:
Agreement (concordance) between Dora Care and clinician-collected data (Intake and Follow-up)