N/A
N=91
The Impact of Sharing Audio Recorded Clinic Visits on Self-management in Older Adults
Diabetes Mellitus · Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT04344301 ↗Enrolled (actual)
91
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Participant Retention (Feasibility) — 44; 45 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Audio recording (Other)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participant Retention (Feasibility) |
44; 45 | — |
| PRIMARY Intervention Fidelity (Feasibility) |
42 | — |
| PRIMARY Feasibility of Intervention Measure (FIM) |
41 | — |
| PRIMARY Participant Recruitment Rate (Acceptability) |
91 | — |
| PRIMARY Intervention Use (Acceptability) |
40 | — |
| PRIMARY Acceptability of Intervention Measure (AIM) |
39 | — |
Summary
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).
Eligibility Criteria
Aim 1 Inclusion Criteria
- Age 65 years or older
- Diagnosed with diabetes mellitus (Type 1 or 2) and hypertension, and receiving medication for both
- Are patients of clinicians at the study clinic
- Have had one or more clinic visits in the previous seven months
- Plan on receiving care at the study clinic for the next six months
Exclusion Criteria
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT04344301). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.