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| ID | Type | Description | Link |
|---|---|---|---|
| 1R56AG061522-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| The University of Texas Medical Branch, Galveston | OTHER |
| Vanderbilt University Medical Center | OTHER |
| Dartmouth College | OTHER |
| National Institutes of Health (NIH) |
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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).
Up to eighty percent of clinic visit information is forgotten by patients immediately post-visit. This is a significant barrier to self-management, especially in older adults with multimorbidity leading to poor health outcomes. After visit summaries (AVS) can improve recall, yet concerns exist about their layout, accuracy and low patient uptake. Patients and clinicians have begun audio recording clinic visits. When patients receive an audio recording of the visit, 71% listen and 68% share it with a caregiver, resulting in greater recall. Despite its growing use, to date, there is no research on the impact of recording and sharing clinic visits of patient self-management ability, health-related outcomes or healthcare utilization. The objective of this proposal is to conduct a multi-site pilot trial evaluating the feasibility and acceptability of routinely sharing audio recordings of clinic visits (AUDIO) in older adults (≥65 years) with diabetes and hypertension.
Conduct a multi-site, two-arm, parallel-group, patient-randomized, blocked, controlled, pilot trial with 3-month follow up, to determine the feasibility and acceptability of sharing audio recordings of clinic visits (AUDIO) on self-management in older adults with diabetes and hypertension, compared to the after visit written summary (AVS) alone (Usual Care). Investigators will determine:
1.1 Feasibility of a larger trial by meeting recruitment targets at each site (n=30 per site; total n=90) and determining the optimal strategy to achieve a high retention rate and adherence to the study protocol.
1.2 Acceptability by assessing the proportion of patients and clinicians who agree to take part in the project and the proportion of patients who listen to the recording.
1.3 Potential effectiveness by collecting data on the impact of audio recordings on self-management, health-related outcomes, healthcare utilization, and clinician behavior. Investigators hypothesize that compared to those receiving UC, patients randomized to also receive audio recordings (AUDIO) of clinic visits will report a greater self-management activation (Patient Activation Measure - Short Form) at 3 months. Investigators will also explore whether the effect of AUDIO on self-management activation compared to UC is greater for patients with low health literacy than those with high health literacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AUDIO | Experimental | Participant clinic visits will be audio recorded locally on a secure, HIPAA-compliant server. Patient access to recordings will be performed via a secure web-based platform. Additionally, participants will be offered the After Visit Summary (AVS) prior to clinic departure, per Usual Care (UC) |
|
| Usual Care | No Intervention | During the trial, patients will be offered to receive the AVS prior to clinic departure as is the current standard at each site. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Audio recording | Other | The investigators will audio record the visits of patients in the intervention group. An RA will enter the exam room and begin the recording with the patient's permission. The patient and clinician can choose to stop or start the recording at any time. Once the visit is complete, the RA will enter the room, turn off the recording, and bring the patient to a private room where the RA will follow standardized instructions demonstrating how to access recordings. Patient access to recordings will be possible via a secure web-based platform. Patients will also receive reminders to listen to their recordings. |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Retention (Feasibility) | The proportion of included participants completing the 3-month (T2) follow up assessment. | 3 months from baseline |
| Intervention Fidelity (Feasibility) | The proportion of participants in the intervention arm that received the audio recording intervention with full adherence to a pre-defined protocol fidelity checklist. Any deviations will be documented. | 3 months from baseline |
| Feasibility of Intervention Measure (FIM) | The FIM is a four-item patient-reported measure of intervention feasibility. Each item is scored from 1 (completely disagree) to 5 (completely agree), with a higher score indicating greater feasibility. We consider a score of ≥ 3 or higher to indicate the acceptable Feasibility of the intervention. We report the proportion of patients in the Intervention arm who scored ≥ 3. | 3 months from baseline |
| Participant Recruitment Rate (Acceptability) | We considered our trial to be acceptable to patients if we could meet recruitment targets at each site of 30 patients. We also calculated our recruitment rate based on the number of potentially eligible patients contacted. | Baseline |
| Intervention Use (Acceptability) | The proportion of participants in the intervention arm that listen to the recordings received during the study period. | 3 months from baseline |
| Acceptability of Intervention Measure (AIM) | The AIM is a four-item patient-reported measure of intervention acceptability. Each item is scored from 1 (completely disagree) to 5 (completely agree), with a higher score indicating greater acceptability. We consider a score of ≥ 3 or higher to indicate adequate acceptability of the intervention. We report the proportion of patients in the Intervention arm who scored ≥ 3. |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient Activation Measure-Short Form (PAM-SF) | The Patient Activation Measure-Short Form is a 13-item patient reported measure. Scores range from 0 (low activation) to 100 (high activation). | 3-Months from enrollment |
| Interpersonal Processes of Care Scale (IPC) |
Aim 1 Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Manchester | Manchester | New Hampshire | 03104 | United States | ||
| Vanderbilt University Medical Center |
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.
At the completion of data analysis
Contact PI to request data
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Of 420 potential patients who received a mailed study invitation letter, we recruited 91: 120 patients were ineligible; 15 patients opted out; 122 declined during a screening call; 65 could not be reached and 7 could not take part for other reasons
Participant recruitment began with study clinicians who were recruited beginning in August 2020. Patient participants were recruited from study clinicians at three academic medical center-affiliated primary care clinics between October 2020 and September 2021. Letters were sent to potentially eligible patients, and after a two-week opt-out period, study coordinators contact patients to determine the patient's interest in the project and eligibility.
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| ID | Title | Description |
|---|---|---|
| FG000 | AUDIO | Participant clinic visits will be audio recorded locally on a secure, HIPAA-compliant server. Patient access to recordings will be performed via a secure web-based platform. Additionally, participants will be offered the After Visit Summary (AVS) prior to clinic departure, per Usual Care (UC) Audio recording: The investigators will audio record the visits of patients in the intervention group. An RA will enter the exam room and begin the recording with the patient's permission. The patient and clinician can choose to stop or start the recording at any time. Once the visit is complete, the RA will enter the room, turn off the recording, and bring the patient to a private room where the RA will follow standardized instructions demonstrating how to access recordings. Patient access to recordings will be possible via a secure web-based platform. Patients will also receive reminders to listen to their recordings. |
| FG001 | Usual Care | During the trial, patients will be offered to receive the AVS prior to clinic departure as is the current standard at each site. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | AUDIO | Participant clinic visits will be audio recorded locally on a secure, HIPAA-compliant server. Patient access to recordings will be performed via a secure web-based platform. Additionally, participants will be offered the After Visit Summary (AVS) prior to clinic departure, per Usual Care (UC) Audio recording: The investigators will audio record the visits of patients in the intervention group. An RA will enter the exam room and begin the recording with the patient's permission. The patient and clinician can choose to stop or start the recording at any time. Once the visit is complete, the RA will enter the room, turn off the recording, and bring the patient to a private room where the RA will follow standardized instructions demonstrating how to access recordings. Patient access to recordings will be possible via a secure web-based platform. Patients will also receive reminders to listen to their recordings. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participant Retention (Feasibility) | The proportion of included participants completing the 3-month (T2) follow up assessment. | Posted | Count of Participants | Participants | 3 months from baseline |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AUDIO | Participant clinic visits will be audio recorded locally on a secure, HIPAA-compliant server. Patient access to recordings will be performed via a secure web-based platform. Additionally, participants will be offered the After Visit Summary (AVS) prior to clinic departure, per Usual Care (UC) Audio recording: The investigators will audio record the visits of patients in the intervention group. An RA will enter the exam room and begin the recording with the patient's permission. The patient and clinician can choose to stop or start the recording at any time. Once the visit is complete, the RA will enter the room, turn off the recording, and bring the patient to a private room where the RA will follow standardized instructions demonstrating how to access recordings. Patient access to recordings will be possible via a secure web-based platform. Patients will also receive reminders to listen to their recordings. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paul Barr | Dartmouth College | +1-603-653-0863 | paul.j.barr@dartmouth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 29, 2022 | May 15, 2023 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000087983 | Sound Recordings |
| ID | Term |
|---|---|
| D001296 | Audiovisual Aids |
| D018961 | Educational Technology |
| D013672 | Technology |
| D013676 | Technology, Industry, and Agriculture |
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| NIH |
| National Institute on Aging (NIA) | NIH |
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.
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| 3 months from baseline |
Interpersonal Processes of Care Scale is an 18-item patient-reported measure assessing 7 sub-domains of interpersonal communication (Hurried communication; Elicited concerns, responded; Explained results, medications; Patient-centered decision making; Compassionate, respectful; Discrimination; Disrespectful office staff ). Direction of scoring: All scales are scored so that higher scores indicate higher frequency of the labeled interpersonal process. Thus, higher scores sometimes indicate better processes (e.g., decided together) and sometimes worse processes (e.g., lack of clarity). Calculating scores: All IPC items use an identical set of response options: 1='never'; 2='rarely'; 3='sometimes'; 4='usually'; 5='always.' Scale scores are calculated as the mean of non-missing responses to the corresponding items (i.e., item responses are averaged). Thus, scores have a possible range of 1-5 and can be calculated for an individual if at least one item per scale has a valid response. |
| 1-Week from baseline visit |
| Patient Satisfaction Questionnaire-18 (PSQ-18) | Patient Satisfaction Questionnaire-18 is a patient reported measure of satisfaction with seven dimensions: general satisfaction; technical quality; interpersonal manner; communication; financial aspects; time spent with doctor; accessibility and convenience. Responses are on a 5-point scale (Strongly agree - strongly disagree). Scores are averaged between 1 - 5; items 1,2,3,5,6,8,11,15,18 should be reversed scored i.e., 1 to 5, 2 to 4, 4 to 2, 5 to 1. Higher agreement reflects higher satisfaction with care. | Baseline,1-Week, and 3-Months from enrollment |
| Medical Outcomes Study General Adherence Measure | The Medical Outcomes Study General Adherence measure, is a five-item patient reported measure of general treatment adherence. | 3-Months from enrollment |
| Adherence to Refills and Medications (ARMS- 7) | Adherence to Refills and Medications is a Seven-item patient reported measure of medication adherence. | 3-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. | 3-Months from enrollment |
| EURO-QoL (EQ-5D) | EURO-QOL is patient reported measure of quality of life (QOL) that can be calculated using responses to Global PROMIS. | Baseline,1-Week, and 3-Months from enrollment |
| Primary Care Contact, ER Visits & Hospitalization | Information on primary care contacts (phone calls, visits), ER visits & hospitalization will be collected via EMR. Baseline assessment will calculate primary care contacts, ER visits & hospitalization for each participant. | 3-Months from enrollment |
| Quality of Diabetes and Hypertension Care | Information on quality of diabetes and hypertension, including referrals to specialists and intensification of medication therapy, will be collected via EMR. | 3-Months from enrollment |
| Patient Health Questionnaire (PHQ- 8) | The eight-item depression scale PHQ-8 is a patient-reported multipurpose instrument to diagnose and measure the severity of depression. Scores range from 0 (no symptoms) - 24 (severe symptoms). | Baseline,1-Week, and 3-Months from enrollment |
| Generalized Anxiety Disorder (GAD-7) | The seven-item GAD-7 is a patient reported measure assessing severity of anxiety. | 3-Months from enrollment |
| Comprehensive Diabetes Stigma Scale (CDSS-15) | The comprehensive diabetes stigma scale (CDSS-15) is a validated 15-item assessment of diabetes-related stigma. | Baseline,1-Week, and 3-Months from enrollment |
| Stigma Scale for Chronic Illness (SSCI-8) | The Stigma Scale for Chronic Illness (SSCI-8) is validated, eight-item assessment of stigma related to chronic disease. | Baseline,1-Week, and 3-Months from enrollment |
| Nashville |
| Tennessee |
| 37232 |
| United States |
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
| BG001 | Usual Care | During the trial, patients will be offered to receive the AVS prior to clinic departure as is the current standard at each site. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Usual Care | During the trial, patients will be offered to receive the AVS prior to clinic departure as is the current standard at each site. |
|
|
| Primary | Intervention Fidelity (Feasibility) | The proportion of participants in the intervention arm that received the audio recording intervention with full adherence to a pre-defined protocol fidelity checklist. Any deviations will be documented. | Posted | Count of Participants | Participants | 3 months from baseline |
|
|
|
| Primary | Feasibility of Intervention Measure (FIM) | The FIM is a four-item patient-reported measure of intervention feasibility. Each item is scored from 1 (completely disagree) to 5 (completely agree), with a higher score indicating greater feasibility. We consider a score of ≥ 3 or higher to indicate the acceptable Feasibility of the intervention. We report the proportion of patients in the Intervention arm who scored ≥ 3. | Of 45 patients assigned to the Intervention arm, 42 completed the FIM survey. As such the overall number of participants analyzed for this outcome is 42. | Posted | Count of Participants | Participants | 3 months from baseline |
|
|
|
| Primary | Participant Recruitment Rate (Acceptability) | We considered our trial to be acceptable to patients if we could meet recruitment targets at each site of 30 patients. We also calculated our recruitment rate based on the number of potentially eligible patients contacted. | Of 420 potential patients who received a mailed study invitation letter, we recruited 91; 120 patients were ineligible; 15 patients opted out; 122 declined during a screening call; 65 could not be reached and 7 could not take part for other reasons (e.g., natural disaster, study staff COVID Quarantine). This resulted in 228 potentially eligible patients. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Primary | Intervention Use (Acceptability) | The proportion of participants in the intervention arm that listen to the recordings received during the study period. | Posted | Count of Participants | Participants | 3 months from baseline |
|
|
|
| Primary | Acceptability of Intervention Measure (AIM) | The AIM is a four-item patient-reported measure of intervention acceptability. Each item is scored from 1 (completely disagree) to 5 (completely agree), with a higher score indicating greater acceptability. We consider a score of ≥ 3 or higher to indicate adequate acceptability of the intervention. We report the proportion of patients in the Intervention arm who scored ≥ 3. | Of 45 patients assigned to the Intervention arm, 42 completed the AIM survey. As such the overall number of participants analyzed for this outcome is 42. | Posted | Count of Participants | Participants | 3 months from baseline |
|
|
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| Other Pre-specified | Patient Activation Measure-Short Form (PAM-SF) | The Patient Activation Measure-Short Form is a 13-item patient reported measure. Scores range from 0 (low activation) to 100 (high activation). | Not Posted | 3-Months from enrollment | Participants |
| Other Pre-specified | Interpersonal Processes of Care Scale (IPC) | Interpersonal Processes of Care Scale is an 18-item patient-reported measure assessing 7 sub-domains of interpersonal communication (Hurried communication; Elicited concerns, responded; Explained results, medications; Patient-centered decision making; Compassionate, respectful; Discrimination; Disrespectful office staff ). Direction of scoring: All scales are scored so that higher scores indicate higher frequency of the labeled interpersonal process. Thus, higher scores sometimes indicate better processes (e.g., decided together) and sometimes worse processes (e.g., lack of clarity). Calculating scores: All IPC items use an identical set of response options: 1='never'; 2='rarely'; 3='sometimes'; 4='usually'; 5='always.' Scale scores are calculated as the mean of non-missing responses to the corresponding items (i.e., item responses are averaged). Thus, scores have a possible range of 1-5 and can be calculated for an individual if at least one item per scale has a valid response. | Not Posted | 1-Week from baseline visit | Participants |
| Other Pre-specified | Patient Satisfaction Questionnaire-18 (PSQ-18) | Patient Satisfaction Questionnaire-18 is a patient reported measure of satisfaction with seven dimensions: general satisfaction; technical quality; interpersonal manner; communication; financial aspects; time spent with doctor; accessibility and convenience. Responses are on a 5-point scale (Strongly agree - strongly disagree). Scores are averaged between 1 - 5; items 1,2,3,5,6,8,11,15,18 should be reversed scored i.e., 1 to 5, 2 to 4, 4 to 2, 5 to 1. Higher agreement reflects higher satisfaction with care. | Not Posted | Baseline,1-Week, and 3-Months from enrollment | Participants |
| Other Pre-specified | Medical Outcomes Study General Adherence Measure | The Medical Outcomes Study General Adherence measure, is a five-item patient reported measure of general treatment adherence. | Not Posted | 3-Months from enrollment | Participants |
| Other Pre-specified | Adherence to Refills and Medications (ARMS- 7) | Adherence to Refills and Medications is a Seven-item patient reported measure of medication adherence. | Not Posted | 3-Months from enrollment | Participants |
| Other Pre-specified | 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. | Not Posted | 3-Months from enrollment | Participants |
| Other Pre-specified | EURO-QoL (EQ-5D) | EURO-QOL is patient reported measure of quality of life (QOL) that can be calculated using responses to Global PROMIS. | Not Posted | Baseline,1-Week, and 3-Months from enrollment | Participants |
| Other Pre-specified | Primary Care Contact, ER Visits & Hospitalization | Information on primary care contacts (phone calls, visits), ER visits & hospitalization will be collected via EMR. Baseline assessment will calculate primary care contacts, ER visits & hospitalization for each participant. | Not Posted | 3-Months from enrollment | Participants |
| Other Pre-specified | Quality of Diabetes and Hypertension Care | Information on quality of diabetes and hypertension, including referrals to specialists and intensification of medication therapy, will be collected via EMR. | Not Posted | 3-Months from enrollment | Participants |
| Other Pre-specified | Patient Health Questionnaire (PHQ- 8) | The eight-item depression scale PHQ-8 is a patient-reported multipurpose instrument to diagnose and measure the severity of depression. Scores range from 0 (no symptoms) - 24 (severe symptoms). | Not Posted | Baseline,1-Week, and 3-Months from enrollment | Participants |
| Other Pre-specified | Generalized Anxiety Disorder (GAD-7) | The seven-item GAD-7 is a patient reported measure assessing severity of anxiety. | Not Posted | 3-Months from enrollment | Participants |
| Other Pre-specified | Comprehensive Diabetes Stigma Scale (CDSS-15) | The comprehensive diabetes stigma scale (CDSS-15) is a validated 15-item assessment of diabetes-related stigma. | Not Posted | Baseline,1-Week, and 3-Months from enrollment | Participants |
| Other Pre-specified | Stigma Scale for Chronic Illness (SSCI-8) | The Stigma Scale for Chronic Illness (SSCI-8) is validated, eight-item assessment of stigma related to chronic disease. | Not Posted | Baseline,1-Week, and 3-Months from enrollment | Participants |
| 0 |
| 45 |
| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | Usual Care | During the trial, patients will be offered to receive the AVS prior to clinic departure as is the current standard at each site. | 1 | 46 | 0 | 46 | 0 | 46 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |