The Effect of Clinic Visit Audio Recordings for Self-management in Older Adults

NCT ID: NCT05824572

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 336 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2027-05-31

Brief Summary

The objective of this study is to conduct a multisite trial evaluating the impact of adding an audio recording of clinic visits (AUDIO) to usual care in older adults with multimorbidity, including diabetes, compared to After Visit Summary (AVS) alone (Usual Care; UC).

Detailed Description

The objective of this study is to conduct a multisite trial evaluating the impact of adding an audio recording of clinic visits (AUDIO) to usual care in older adults with multimorbidity, including diabetes, compared to AVS alone (Usual Care; UC). The specific aims are: Aim 1 Conduct a three-site trial in primary care where older patients with multimorbidity including diabetes (n=336) will be randomized to receive an audio recording as well as AVS (AUDIO) versus AVS alone (UC) for all scheduled clinic visits over 12 months; patients will be assessed at baseline, 1 week, 6 months and 12 months. Applicants hypothesize (Main Effect) that: compared to those receiving UC, patients randomized to also receive audio recordings (AUDIO) of clinic visits will report a greater self-management ability (Primary Outcome), with improved quality of life, medication adherence, and satisfaction (Secondary Outcomes) at 12 months.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Audio

Researchers will audio record both in-person and telehealth visits of participants in the intervention group.

Group Type: ACTIVE_COMPARATOR

Clinic visit audio recordings for self-management in older adults

Intervention Type: OTHER

The intervention is audio-recordings of primary care clinic visits that are shared with participating patients. All scheduled visits with study clinicians will be recorded and shared with patients randomized to the intervention group (AUDIO) for 12 months.

Usual care

Participants will receive Usual Care

Group Type: PLACEBO_COMPARATOR

Usual Care

Intervention Type: OTHER

The Usual Care arm participants will receive After Visit Summaries (AVS) per the standard delivery at each institution

Interventions

Clinic visit audio recordings for self-management in older adults

The intervention is audio-recordings of primary care clinic visits that are shared with participating patients. All scheduled visits with study clinicians will be recorded and shared with patients randomized to the intervention group (AUDIO) for 12 months.

Intervention Type: OTHER

Usual Care

The Usual Care arm participants will receive After Visit Summaries (AVS) per the standard delivery at each institution

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients who are ≥ 65 years;
• Patients with multimorbidity (i.e. patient has diabetes and one or more chronic conditions including: arthritis, asthma, atrial fibrillation, cancer, chronic obstructive pulmonary disease, heart disease, depression, heart failure, hypertension, osteoporosis, kidney disease and stroke);
• Have had two or more clinic visits in the previous 12 months;
• Plan on receiving ongoing care at the clinic for the subsequent 12 months;
• Do not have any vision or hearing problems that cannot be corrected;
• Have not recorded a clinic visit for personal use i the past 6 months.

• Licensed clinician (MD including clinician residents at Dartmouth Health locations, DO, APRN, NP, PA)
• Are based at the study clinic;
• Who treat adult patients.

Exclusion Criteria

• Without capacity to consent to the project;
• With schizophrenia and other psychotic disorders, substance-use disorders, uncorrectable hearing or visual impairment or a six item screener (SIS) cognitive function score ≤ 4;
• Living in skilled nursing homes or hospice;
• Patients who have audio- recorded a clinic visit for their personal use in the previous six months;
• Patients who do not speak English or Spanish;
• Patients who lack internet access;
• Patients who (a) do not have access to a personal email, (b) do not have an email address shared with a family member or patient-identified caregiver, and (c) are not interested in creating an email account between the time they are first contacted by the study team to the time that the study team requires an email address to initiate the online recording software registration.

Clinician participants:

• Are trainees, e.g., fellows, medical students or residents, with the exception of clinician residents at Dartmouth Health;
• Commonly audio or video record clinic visits for patient's personal use.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: collaborator

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Paul J. Barr

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul J Barr, PhD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth College

Kerri L Cavanaugh, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilit University Medical Center

Meredith C Masel, PhD

Role: PRINCIPAL_INVESTIGATOR

University Texas Medical Branch

Locations

Dartmouth-Hitchcook Manchester

Manchester, New Hampshire, United States

Site Status: RECRUITING

Vanderbit University Medical Center

Nashville, Tennessee, United States

Site Status: RECRUITING

University of Texas Medical Branch

Galveston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Paul J Barr, PhD

Role: CONTACT

paul.j.barr@dartmouth.edu

603 646 7016

Susan M Tarczewski

Role: CONTACT

susan.m.tarczewski@dartmouth.edu

603 646 7066

Facility Contacts

Paul J Barr, PhD

Role: primary

paul.j.barr@dartmouth.edu

603 646 7016

Susan M Tarczewski

Role: backup

Susan.M.Tarczewski@dartmouth.edu

603 646 7066

Kerri L Cavanaugh, MD

Role: primary

kerri.cavanaugh@vumc.org

615 875 2737

Sonya L Williams

Role: backup

sonya.I.williams@vumc.org

615 875 2737

Meredith C Masel, PhD

Role: primary

mcmasel@utmb.edu

409 747 6009

Isamar Ortiz

Role: backup

iiortiz@UTMB.EDU

409-266-3009

Other Identifiers

1R01AG074959-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY02001844

Identifier Type: -

Identifier Source: org_study_id