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NCT Number: NCT05824572

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

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).

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth-Hitchcook Manchester, Manchester, New Hampshire, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patients participants:

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.

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:

Inclusion criteria

  • 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

  • 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.

Treatment and study plan

Clinic visit audio recordings for self-management in older adults

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

Other

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. Adherence to Refills and Medications-D (ARMS-D)

    Time frame: Adherence at 12-months from enrollment

    Eleven-item measure of medication adherence in diabetes. Two domains: i) Medication taking; and ii) medication refill.

  2. Global PROMIS 10

    Time frame: Global PROMIS 10 at 12 month from enrollment

    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.

  3. Patient Satisfaction Questionnaire-18

    Time frame: Patient satisfaction at 12-months from enrollment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Paul J Barr, PhD

CONTACT

[email protected]

603 646 7016

Susan M Tarczewski

CONTACT

[email protected]

603 646 7066

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • National Institute on Aging (NIA)
  • National Institutes of Health (NIH)
  • The University of Texas Medical Branch, Galveston
  • Vanderbilt University Medical Center

Registry information

Acronym: REPLAY

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Apr 21, 2023
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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