The Impact of Sharing Audio Recorded Clinic Visits on Self-management in Older Adults

NCT04344301 | Completed Results DMC

• 2 other identifiers: D200721R56AG061522-01A1
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 3

Brief 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

Diabetes Mellitus; Hypertension

Keywords

Audio recording; Diabetes Mellitus; Hypertension; Patient-centered communication; Self-management; Older adults

Outcome Measures

Primary Outcomes (6)

• Participant Retention (Feasibility)

  The proportion of included participants completing the 3-month (T2) follow up assessment.

  3 months from baseline

• Intervention Fidelity (Feasibility)

  The proportion of participants in the intervention arm that received the audio recording intervention with full adherence to a pre-defined protocol fidelity checklist. Any deviations will be documented.

  3 months from baseline

• Feasibility of Intervention Measure (FIM)

  The FIM is a four-item patient-reported measure of intervention feasibility. Each item is scored from 1 (completely disagree) to 5 (completely agree), with a higher score indicating greater feasibility. We consider a score of ≥ 3 or higher to indicate the acceptable Feasibility of the intervention. We report the proportion of patients in the Intervention arm who scored ≥ 3.

  3 months from baseline

• Participant Recruitment Rate (Acceptability)

  We considered our trial to be acceptable to patients if we could meet recruitment targets at each site of 30 patients. We also calculated our recruitment rate based on the number of potentially eligible patients contacted.

  Baseline

• Intervention Use (Acceptability)

  The proportion of participants in the intervention arm that listen to the recordings received during the study period.

  3 months from baseline

• Acceptability of Intervention Measure (AIM)

  The AIM is a four-item patient-reported measure of intervention acceptability. Each item is scored from 1 (completely disagree) to 5 (completely agree), with a higher score indicating greater acceptability. We consider a score of ≥ 3 or higher to indicate adequate acceptability of the intervention. We report the proportion of patients in the Intervention arm who scored ≥ 3.

  3 months from baseline

Other Outcomes (13)

• Patient Activation Measure-Short Form (PAM-SF)

  3-Months from enrollment

• Interpersonal Processes of Care Scale (IPC)

  1-Week from baseline visit

• Patient Satisfaction Questionnaire-18 (PSQ-18)

  Baseline,1-Week, and 3-Months from enrollment

Study Arms (2)

AUDIO

EXPERIMENTAL

Participant clinic visits will be audio recorded locally on a secure, HIPAA-compliant server. Patient access to recordings will be performed via a secure web-based platform. Additionally, participants will be offered the After Visit Summary (AVS) prior to clinic departure, per Usual Care (UC)

Other: Audio recording

Usual Care

NO INTERVENTION

During the trial, patients will be offered to receive the AVS prior to clinic departure as is the current standard at each site.

Interventions

Audio recording OTHER

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.

AUDIO

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65 years or older
• Diagnosed with diabetes mellitus (Type 1 or 2) and hypertension, and receiving medication for both
• Are patients of clinicians at the study clinic
• Have had one or more clinic visits in the previous seven months
• Plan on receiving care at the study clinic for the next six months

You may not qualify if:

• Without the capacity to provide informed consent
• Diagnosis of dementia
• Diagnosis of schizophrenia and other psychotic disorders
• Current substance-abuse use disorder
• Diagnosis of an uncorrectable hearing or visual impairment, with no adjustments to support accessing the interventions or surveys
• Six item screener of cognitive function score 4 or less
• Living in a skilled nursing home or hospice
• Have audio-recorded a clinic visit for personal use within the past six months
• Do not have a personal email, do not have an email address shared with a family member or patient-identified caregiver, and/or are not willing to create an email account between the first contact from the study team and the initiation of online recording software registration

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• The University of Texas Medical Branch, Galveston: collaborator
• Vanderbilt University Medical Center: collaborator
• Dartmouth College: collaborator
• National Institutes of Health (NIH): collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (3)

Dartmouth-Hitchcock Manchester

Manchester, New Hampshire, 03104, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension

Interventions

Sound Recordings

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Dr. Paul Barr
• Organization: Dartmouth College

paul.j.barr@dartmouth.edu

+1-603-653-0863

Study Officials

• Paul J Barr, PhD

  Dartmouth College

  PRINCIPAL INVESTIGATOR

• Kerri L Cavanaugh, MD

  Vanderbilit University Medical Center

  PRINCIPAL INVESTIGATOR

• Meredith C Masel, PhD

  University Texas Medical Branch

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Patients will be randomly allocated to AUDIO or UC alone using a block-randomization technique with the clinician acting as the blocking variable; this strategy will ensure an equal number of patients per clinician will be randomly assigned to each study arm.

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 14, 2020
• Study Start: August 31, 2020
• Primary Completion: February 14, 2022
• Study Completion: February 14, 2022
• Last Updated: July 18, 2025
• Results First Posted: August 7, 2023

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: At the completion of data analysis
• Access Criteria: Contact PI to request data

Locations

US (3)