NCT05824572

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
336

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
13mo left

Started Dec 2023

Longer than P75 for not_applicable diabetes

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Dec 2023May 2027

First Submitted

Initial submission to the registry

April 7, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 21, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

July 14, 2025

Status Verified

July 1, 2025

Enrollment Period

3.2 years

First QC Date

April 7, 2023

Last Update Submit

July 9, 2025

Conditions

Diabetes

Keywords

Audio recordingDiabetes MellitusPatient-centered communicationSelf-managementOlder adultsDoctor patient communicationTechnologyMultimorbidity

Outcome Measures

Primary Outcomes (1)

  • 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).

    Patient activation at 12-months from enrollment

Secondary Outcomes (3)

  • Adherence to Refills and Medications-D (ARMS-D)

    Adherence at 12-months from enrollment

  • Global PROMIS 10

    Global PROMIS 10 at 12 month from enrollment

  • Patient Satisfaction Questionnaire-18

    Patient satisfaction at 12-months from enrollment

Study Arms (2)

Audio

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

Usual care

PLACEBO COMPARATOR

Participants will receive Usual Care

Other: Usual Care

Interventions

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.

Audio
Usual CareOTHER

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

Usual care

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Dartmouth-Hitchcook Manchester

Manchester, New Hampshire, 03104, United States

RECRUITING

Vanderbit University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

University of Texas Medical Branch

Galveston, Texas, 77555, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Self-ManagementAging

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

RehabilitationHealth ServicesHealth Care Facilities Workforce and ServicesGrowth and DevelopmentPhysiological Phenomena

Study Officials

  • Paul J Barr, PhD

    Dartmouth College

    PRINCIPAL INVESTIGATOR

  • Kerri L Cavanaugh, MD

    Vanderbilit University Medical Center

    PRINCIPAL INVESTIGATOR

  • Meredith C Masel, PhD

    University Texas Medical Branch

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul J Barr, PhD

CONTACT

603 646 7016paul.j.barr@dartmouth.edu

Susan M Tarczewski

CONTACT

603 646 7066susan.m.tarczewski@dartmouth.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 7, 2023

First Posted

April 21, 2023

Study Start

December 1, 2023

Primary Completion (Estimated)

January 28, 2027

Study Completion (Estimated)

May 31, 2027

Last Updated

July 14, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
Time Frame
At the completion of data analysis
Access Criteria
Contact PI to request data

Locations

US(3)