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).



Eligible Ages
Over 65 Years
Eligible Genders
Accepts Healthy Volunteers

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, 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; - Commonly audio or video record clinic visits for patient's personal use.

Study Design

Study Type
Intervention Model
Parallel Assignment
Intervention 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
Primary Purpose
Health Services Research
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Researchers will audio record both in-person and telehealth visits of participants in the intervention group.
  • Other: 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.
Placebo Comparator
Usual care
Participants will receive Usual Care
  • Other: Usual Care
    The Usual Care arm participants will receive After Visit Summaries (AVS) per the standard delivery at each institution

Recruiting Locations

University of Texas Medical Branch
Galveston, Texas 77555
Meredith C Masel, PhD

More Details

Dartmouth-Hitchcock Medical Center

Study Contact

Paul J Barr, PhD
603 646 7016

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.


Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.