DiabetesREPLAYNCT05824572

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

A study testing Clinic visit audio recordings for self-management in older adults in people with Diabetes, run by Dartmouth-Hitchcock Medical Center at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 65 years and older
Conditions the study is for: Diabetes
What is being tested?: Clinic visit audio recordings for self-management in older adults
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 336 participants
Where: 3 sitesUnited States
Study dates: 1 Dec 2023to 31 Dec 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

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

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.

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

Who cannot join

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;

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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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

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

Other trials in United States

About this study

Read the 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
Being tested: Clinic visit audio recordings for self-management in older adults, Usual Care
Keywords: Audio recording, Diabetes Mellitus, Patient-centered communication, Self-management, Older adults, Doctor patient communication, Technology, Multimorbidity
Medical subject headings: Diabetes Mellitus

What participants receive

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

Clinic visit audio recordings for self-management in older adultsOther
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 CareOther
The Usual Care arm participants will receive After Visit Summaries (AVS) per the standard delivery at each institution

Study groups in NCT05824572
Study group	Role	What they receive
Audio	Active comparator	Researchers will audio record both in-person and telehealth visits of participants in the intervention group. Receives: Other: Clinic visit audio recordings for self-management in older adults
Usual care	Placebo comparator	Participants will receive Usual Care Receives: Other: Usual Care

What is being measured

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

Patient Activation Measure-Short Form
The Patient Activation Measure-Short Form is a 13-item patient reported measure. Scores range from 0 (low activation) to 100 (high activation).
Measured: Patient activation at 12-months from enrollment

Secondary outcomes (3)

Adherence to Refills and Medications-D (ARMS-D)
Eleven-item measure of medication adherence in diabetes. Two domains: i) Medication taking; and ii) medication refill.
Measured: Adherence at 12-months from enrollment
Global PROMIS 10
Global PROMIS (Patient-Reported Outcome Measurement Information System) is a 10-item patient reported measure with two domains: mental and physical health. Domain scores range from 4 to 20, with higher scores representing better health.
Measured: Global PROMIS 10 at 12 month from enrollment
Patient Satisfaction Questionnaire-18
Patient Satisfaction Questionnaire-18 (PSQ-18) is a patient reported measure of satisfaction. It assesses seven sub-scales of satisfaction with care with scores ranging from 1 - 5 for each. We will use the two-item domain assessing general satisfaction.
Measured: Patient satisfaction at 12-months from enrollment

Timeline

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

1 Dec 202331 Dec 2027

First posted21 Apr 2023
Study start1 Dec 2023
Primary completion30 Jun 2027 (estimated)
Study completion31 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for DiabetesStudies 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: 336 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05824572
Sponsor's protocol ID: STUDY02001844
Other IDs: 1R01AG074959-01A1
Acronym: REPLAY
Status last verified: Aug 2026
First submitted: 7 Apr 2023
Last updated: 7 Aug 2026
Results posted: No
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?

See locations

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All Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Clinic Visit Audio Recordings for Self-management in Older Adults
ClinicalTrials.gov ID: NCT05824572
Acronym / sponsor ID: REPLAY / STUDY02001844
Conditions: Diabetes
Keywords: Audio recording, Diabetes Mellitus, Patient-centered communication, Self-management, Older adults, Doctor patient communication, Technology, Multimorbidity
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 336 participants (estimated)
Lead sponsor: Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
Collaborators: Vanderbilt University Medical Center, The University of Texas Medical Branch, Galveston, National Institute on Aging (NIA), National Institutes of Health (NIH)
Study start: 1 Dec 2023 (actual)
Primary completion: 30 Jun 2027 (estimated)
Study completion: 31 Dec 2027 (estimated)
First posted: 21 Apr 2023 (actual)
Results: Not posted in the source record

Clinical summary

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

Detailed description

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	Active comparator	Other: Clinic visit audio recordings for self-management in older adultsResearchers will audio record both in-person and telehealth visits of participants in the intervention group.
Usual care	Placebo comparator	Other: Usual CareParticipants will receive Usual Care

Who may qualify

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

Key inclusion criteria (9 listed)

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;

Key exclusion criteria (10 listed)

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;

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
Clinic visit audio recordings for self-management in older adultsThe 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.	Other	Audio
Usual CareThe Usual Care arm participants will receive After Visit Summaries (AVS) per the standard delivery at each institution	Other	Usual care

Primary outcome

Patient Activation Measure-Short Form
Time frame: Patient activation at 12-months from enrollment
The Patient Activation Measure-Short Form is a 13-item patient reported measure. Scores range from 0 (low activation) to 100 (high activation).

3 secondary outcomes

Adherence to Refills and Medications-D (ARMS-D)
Time frame: Adherence at 12-months from enrollment
Global PROMIS 10
Time frame: Global PROMIS 10 at 12 month from enrollment
Patient Satisfaction Questionnaire-18
Time frame: Patient satisfaction at 12-months from enrollment

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
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.

Related trials for Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
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Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
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Chronic Kidney Disease, Hypertension (HTN)

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 Clinic visit audio recordings for self-management in older adults in people with Diabetes, 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 9 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2026. 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

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?

Patient Activation Measure-Short Form (time frame: Patient activation at 12-months from enrollment). 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 NCT05824572.

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 7 Aug 2026.