Diabetes MellitusNCT04344301

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

A study testing Audio recording in people with Diabetes Mellitus and Hypertension, run by Dartmouth-Hitchcock Medical Center at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 65 years and older
Conditions the study is for: Diabetes Mellitus, Hypertension
What is being tested?: Audio recording
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 91 participants
Where: 3 sitesUnited States
Study dates: 31 Aug 2020to 14 Feb 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

None listed.

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

University of Texas Medical Branch
Galveston, Texas, 77555
Dartmouth-Hitchcock Manchester
Manchester, New Hampshire, 03104
Vanderbilt University Medical Center
Nashville, Tennessee, 37232

Other trials in United States

About this study

Official title: The Impact of Sharing Audio Recorded Clinic Visits on Self-management in Older Adults: a Multi-site Trial

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).

Read the detailed description

Up to eighty percent of clinic visit information is forgotten by patients immediately post-visit. This is a significant barrier to self-management, especially in older adults with multimorbidity leading to poor health outcomes. After visit summaries (AVS) can improve recall, yet concerns exist about their layout, accuracy and low patient uptake. Patients and clinicians have begun audio recording clinic visits. When patients receive an audio recording of the visit, 71% listen and 68% share it with a caregiver, resulting in greater recall. Despite its growing use, to date, there is no research on the impact of recording and sharing clinic visits of patient self-management ability, health-related outcomes or healthcare utilization. The objective of this proposal is to conduct a multi-site pilot trial evaluating the feasibility and acceptability of routinely sharing audio recordings of clinic visits (AUDIO) in older adults (≥65 years) with diabetes and hypertension.

Conduct a multi-site, two-arm, parallel-group, patient-randomized, blocked, controlled, pilot trial with 3-month follow up, to determine the feasibility and acceptability of sharing audio recordings of clinic visits (AUDIO) on self-management in older adults with diabetes and hypertension, compared to the after visit written summary (AVS) alone (Usual Care). Investigators will determine:

1.1 Feasibility of a larger trial by meeting recruitment targets at each site (n=30 per site; total n=90) and determining the optimal strategy to achieve a high retention rate and adherence to the study protocol.

1.2 Acceptability by assessing the proportion of patients and clinicians who agree to take part in the project and the proportion of patients who listen to the recording.

1.3 Potential effectiveness by collecting data on the impact of audio recordings on self-management, health-related outcomes, healthcare utilization, and clinician behavior. Investigators hypothesize that compared to those receiving UC, patients randomized to also receive audio recordings (AUDIO) of clinic visits will report a greater self-management activation (Patient Activation Measure - Short Form) at 3 months. Investigators will also explore whether the effect of AUDIO on self-management activation compared to UC is greater for patients with low health literacy than those with high health literacy.

Conditions: Diabetes Mellitus, Hypertension
Being tested: Audio recording
Keywords: Audio recording, Diabetes Mellitus, Hypertension, Patient-centered communication, Self-management, Older adults
Medical subject headings: Diabetes Mellitus, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Audio recordingOther
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.

Study groups in NCT04344301
Study group	Role	What they receive
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) Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Participant Retention (Feasibility)
The proportion of included participants completing the 3-month (T2) follow up assessment.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Intervention Use (Acceptability)
The proportion of participants in the intervention arm that listen to the recordings received during the study period.
Measured: 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.
Measured: 3 months from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Aug 202014 Feb 2022

First posted14 Apr 2020
Study start31 Aug 2020
Primary completion14 Feb 2022
Study completion14 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes MellitusStudies of the same condition, open and under way.
More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: None (open label)
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04344301
Sponsor's protocol ID: D20072
Other IDs: 1R56AG061522-01A1
Status last verified: Jul 2025
First submitted: 10 Apr 2020
Last updated: 18 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Upon publication of results in peer-reviewed journals, access to the de-identified data for research purposes will be considered if a request is made by a qualified individual (i.e., a researcher from a research institute), IRB secured, and mutually agreed upon by the PIs. Any potential users of the data will sign an agreement that no attempt to reveal personal or private information may be made. The investigators will follow the Safe Harbour Methods outlined in the guidance regarding methods for de-identification of protected health information in accordance with the HIPAA Privacy Rule.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Impact of Sharing Audio Recorded Clinic Visits on Self-management in Older Adults: a Multi-site Trial
ClinicalTrials.gov ID: NCT04344301
Acronym / sponsor ID: D20072
Conditions: Diabetes Mellitus, Hypertension
Keywords: Audio recording, Diabetes Mellitus, Hypertension, Patient-centered communication, Self-management, Older adults
Study type: Interventional
Recruitment status: Completed
Enrolment: 91 participants (actual)
Lead sponsor: Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
Collaborators: The University of Texas Medical Branch, Galveston, Vanderbilt University Medical Center, Dartmouth College, National Institutes of Health (NIH), National Institute on Aging (NIA)
Study start: 31 Aug 2020 (actual)
Primary completion: 14 Feb 2022 (actual)
Study completion: 14 Feb 2022 (actual)
First posted: 14 Apr 2020 (actual)
Results: Posted 7 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

1.2 Acceptability by assessing the proportion of patients and clinicians who agree to take part in the project and the proportion of patients who listen to the recording.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
AUDIO	Experimental	Other: Audio recordingParticipant 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)
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.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Audio recordingThe 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.	Other	AUDIO

Primary outcome

Participant Retention (Feasibility)
Time frame: 3 months from baseline
The proportion of included participants completing the 3-month (T2) follow up assessment.
Intervention Fidelity (Feasibility)
Time frame: 3 months from baseline
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.
Feasibility of Intervention Measure (FIM)
Time frame: 3 months from baseline
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.
Participant Recruitment Rate (Acceptability)
Time frame: Baseline
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.
Intervention Use (Acceptability)
Time frame: 3 months from baseline
The proportion of participants in the intervention arm that listen to the recordings received during the study period.
Acceptability of Intervention Measure (AIM)
Time frame: 3 months from baseline
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.

Results and safety

Results posted to the registry on 7 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AUDIO	45	44
Usual Care	46	45

Primary outcome: Participant Retention (Feasibility)

Time frame: 3 months from baseline. Count of participants. Unit: Participants

Measure	AUDIO n = 45	Usual Care n = 46
Value	44	45

Primary outcome: Intervention Fidelity (Feasibility)

Time frame: 3 months from baseline. Count of participants. Unit: Participants

Measure	AUDIO n = 45
Value	42

Primary outcome: Feasibility of Intervention Measure (FIM)

Time frame: 3 months from baseline. Count of participants. Unit: Participants

Measure	AUDIO n = 42
Value	41

Population analysed: Of 45 patients assigned to the Intervention arm, 42 completed the FIM survey. As such the overall number of participants analyzed for this outcome is 42.

Primary outcome: Participant Recruitment Rate (Acceptability)

Time frame: Baseline. Count of participants. Unit: Participants

Measure	Potentially Eligible Patients n = 228
Value	91

Population analysed: Of 420 potential patients who received a mailed study invitation letter, we recruited 91; 120 patients were ineligible; 15 patients opted out; 122 declined during a screening call; 65 could not be reached and 7 could not take part for other reasons (e.g., natural disaster, study staff COVID Quarantine). This resulted in 228 potentially eligible patients.

Adverse events

Time frame: 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AUDIO	0 of 45 (0%)	0 of 45 (0%)	0 of 45
Usual Care	0 of 46 (0%)	0 of 46 (0%)	1 of 46

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Upon publication of results in peer-reviewed journals, access to the de-identified data for research purposes will be considered if a request is made by a qualified individual (i.e., a researcher from a research institute), IRB secured, and mutually agreed upon by the PIs. Any potential users of the data will sign an agreement that no attempt to reveal personal or private information may be made. The investigators will follow the Safe Harbour Methods outlined in the guidance regarding methods for de-identification of protected health information in accordance with the HIPAA Privacy Rule.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Paul J Barr, PhD principal investigator

Dartmouth College

Kerri L Cavanaugh, MD principal investigator

Vanderbilit University Medical Center

Meredith C Masel, PhD principal investigator

University Texas Medical Branch

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Audio recording in people with Diabetes Mellitus and Hypertension, run by Dartmouth-Hitchcock Medical Center at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participant Retention (Feasibility) (time frame: 3 months from baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04344301.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025; AzTrials last refreshed its copy on 7 Nov 2026.