Evaluation of Dora Care for Supporting Fracture Liaison Services (FLS)

NCT07464171 | Not Yet Recruiting DMC

• 3 other identifiers: DORA-FLS-CIP/v1.510102111362559
• Study Type: interventional
• Target: 217
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

AI (Artificial Intelligence); Osteoporosis; Outpatient; Telemedicine; Automation; Risk Assesment; Bone Health

Keywords

AI (Artificial Intelligence); Fracture Liason Services; Conversational AI; Triage; Rheumatology; Telephone Consultation; Telemedicine; Bone Health; Voice AI; Medical Device

Outcome Measures

Primary Outcomes (1)

• 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).

  Intake assessment and Follow-up assessment (planned at 16 weeks)

Secondary Outcomes (9)

• Medication adherence rate

  16 week follow up where available

• Incidence of patient-reported medication side effects

  16 weeks and 24 weeks

• Incidence of new fragility fractures

  16 weeks and 24 weeks

• Incidence of patient-reported falls

  16 weeks and 24 weeks

• Patient satisfaction scores with Dora Care (adapted Client Satisfaction Questionnaire)

  Baseline (intake assessment), 16 weeks, and 24 weeks

Other Outcomes (5)

• Safety Monitoring: Incidence of Device-related Serious Adverse Events (SAEs)

  Through study completion, an average of 12 months

• Safety Monitoring: Missed urgent clinical conditions identified

  Through study completion, an average of 12 months

• Safety Monitoring: Privacy and data security breaches

  Through study completion, an average of 12 months

Study Arms (1)

Patient population receiving Dora call

EXPERIMENTAL

Patient participant will receive a Dora call in addition to their standard care clinical appointment call

Device: Dora call

Interventions

Dora call DEVICE

Patient participant will recieve a Dora call in addition to their standard clinical care telephone appointment

Patient population receiving Dora call

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ufonia: lead
• University College London Hospitals: collaborator
• University of York: collaborator

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Aisling Higham, FRCOphth, MSc, MBBS

  Ufonia

  STUDY DIRECTOR

Central Study Contacts

Ernest Lim, MBBS, BSC

CONTACT

+447585554340; el@ufonia.com

Ellie C Hawkins, MSc

CONTACT

+447780951175; ech@ufonia.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: March 11, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03