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.
Adults aged ≥50 years.
Presenting with a new fragility fracture requiring FLS assessment.
Able to provide informed consent.
English speaking.
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.
Single group
Dora call
DevicePatient participant will recieve a Dora call in addition to their standard clinical care telephone appointment
Agreement (concordance) between Dora Care and clinician-collected data (Intake and Follow-up)
Concordance for predefined variables collected by Dora Care versus those routinely collected by an FLS clinician during baseline care consultation (slot-level agreement; categorical variables via % agreement and Cohen's kappa; continuous variables via ICC and/or Bland-Altman).
Medication adherence rate
Medication adherence rate
Incidence of patient-reported medication side effects
Incidence and type of side effects from anti-osteoporosis medications.
Incidence of new fragility fractures
The incidence of reports of new fragility fractures will be tabulated and presented as frequencies and percentages.
Incidence of patient-reported falls
Incidence of falls reported by patients at follow-up, presented as frequencies and percentages.
Safety Monitoring: Incidence of Device-related Serious Adverse Events (SAEs)
Device-related SAEs (death, life-threatening illness, hospitalisation, permanent disability) occurring within 14 days of Dora Care call, reported as incidence per 100 calls with exact 95% CI.
Safety Monitoring: Missed urgent clinical conditions identified
Number of urgent clinical conditions (e.g., osteonecrosis of the jaw) not identified by Dora Care but subsequently identified during standard care clinical interaction, reported as incidence per 100 calls with exact 95% CI. Acceptance criterion: \<0.5%.
Safety Monitoring: Privacy and data security breaches
Additional Safety Monitoring: Confidentiality violations Incidence per 100 calls ± exact 95 % CI
Safety Monitoring: Incidence of system failures affecting patient safety
Technical failures preventing or impeding patient assessments (e.g., call disconnections, data transfer errors, software bugs), reported as incidence per 100 calls with exact 95% CI. Acceptance criterion: \<3%.
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