The Impact of Sharing Audio Recorded Clinic Visits on Self-management in Older Adults
NCT04344301 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 91
Last updated 2025-07-18
Summary
The investigators will conduct a multi-site, two-arm, parallel-group, patient-randomized, blocked, controlled, pilot trial with a 3-month follow up in older adults (≥65 years) with diabetes and hypertension. Participants will be randomized to receive AUDIO recordings of their clinic visits (AUDIO) in addition to After Visit Summary (AVS), or their AVS alone (Usual Care (UC). The investigators will recruit 90 adults (30 per site) over the targeted recruitment period of approximately 6 months. The primary outcome of interest is the feasibility of the trial and acceptability of the AUDIO intervention. The investigators will also explore the impact of AUDIO on patients' ability to self-manage care (as well as other exploratory health-related outcomes and healthcare utilization) at regular intervals from enrollment (T1 = 1 week, T2 = 3 months) compared to baseline (T0 = pre-visit) and usual care. The investigators will recruit patients from consented clinicians at three sites: Dartmouth-Hitchcock Primary Care (D-H; Manchester, NH), Vanderbilt University Medical Center (VUMC; Nashville, TN), and University of Texas Medical Branch, (UTMB; Galveston, TX).
Conditions
Interventions
- OTHER
-
Audio recording
The investigators will audio record the visits of patients in the intervention group. An RA will enter the exam room and begin the recording with the patient's permission. The patient and clinician can choose to stop or start the recording at any time. Once the visit is complete, the RA will enter the room, turn off the recording, and bring the patient to a private room where the RA will follow standardized instructions demonstrating how to access recordings. Patient access to recordings will be possible via a secure web-based platform. Patients will also receive reminders to listen to their recordings.
Sponsors & Collaborators
-
The University of Texas Medical Branch, Galveston
collaborator OTHER -
Vanderbilt University Medical Center
collaborator OTHER -
Dartmouth College
collaborator OTHER -
National Institutes of Health (NIH)
collaborator NIH -
National Institute on Aging (NIA)
collaborator NIH -
Dartmouth-Hitchcock Medical Center
lead OTHER
Principal Investigators
-
Paul J Barr, PhD · Dartmouth College
-
Kerri L Cavanaugh, MD · Vanderbilit University Medical Center
-
Meredith C Masel, PhD · University Texas Medical Branch
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-08-31
- Primary Completion
- 2022-02-14
- Completion
- 2022-02-14
Countries
- United States
Study Locations
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