Audio Recordings for Diabetes Management

(REPLAY Trial)

Recruiting at 2 trial locations

Overseen By Susan M Tarczewski

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Schizophrenia, Substance-use, Cognitive impairment, others

Compensation: Varies

Number of Visits: 1

Duration: 12 months

336 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if audio recordings of clinic visits can help older adults manage diabetes and other chronic conditions more effectively than a written summary alone. One group of participants will have their clinic visits recorded (Clinic visit audio recordings for self-management in older adults), while the other group will receive the usual written information. The study seeks individuals aged 65 and older with diabetes and at least one other chronic condition, such as heart disease or arthritis, who frequently visit their clinic. As an unphased trial, this study provides a unique opportunity to contribute to innovative approaches in managing chronic conditions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications, so it's best to discuss this with the study team or your doctor.

What prior data suggests that audio recordings for diabetes management are safe?

Research has shown that sharing audio recordings of doctor visits is both feasible and well-received by older adults with multiple health issues, such as diabetes. This method has been tested and appears helpful for managing diabetes when combined with regular in-person doctor visits. No safety issues or problems have been reported from recording these visits. Essentially, this approach aims to improve communication and ensure patients better understand their care instructions. Since it is neither a medication nor a medical procedure, safety concerns remain very low. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using audio recordings for diabetes management because it offers a unique way to enhance self-care among older adults. Unlike standard care, which typically involves verbal instructions during clinic visits, this approach provides patients with a recording of their doctor visits. This means they can revisit and review the advice anytime, potentially improving their understanding and adherence to care plans. By empowering patients with this tool, the goal is to help them manage their diabetes more effectively and independently.

What evidence suggests that audio recordings are effective for diabetes management?

This trial will compare audio recordings of clinic visits with usual care. Studies have shown that 71% of patients listen to an audio recording of their clinic visit, and 68% share it with a caregiver. Sharing these recordings helps patients and caregivers better understand and manage health conditions. Research indicates that audio recordings, combined with regular care, help older adults remember their doctor's advice more effectively. This approach makes managing diabetes and other health issues easier. Overall, audio recordings are practical and beneficial for older adults with multiple health conditions. ^{1 2 3 5 6}

Who Is on the Research Team?

Paul J Barr, PhD

Principal Investigator

Dartmouth College

Meredith C Masel, PhD

Principal Investigator

University Texas Medical Branch

Kerri L Cavanaugh, MD

Principal Investigator

Vanderbilit University Medical Center

Are You a Good Fit for This Trial?

This trial is for older adults aged 65 or above with diabetes and at least one other chronic condition, who have seen their provider twice in the past year and will continue care at the clinic. Participants must not have severe vision or hearing issues, cognitive impairments, live in nursing homes/hospice, have a history of certain mental disorders or substance abuse, lack internet access/email, or speak languages other than English/Spanish.

Inclusion Criteria

I have diabetes and at least one other chronic condition.

I am 65 years old or older.

Have had two or more clinic visits in the previous 12 months

Exclusion Criteria

Clinicians who commonly audio or video record clinic visits for patients' personal use.

Clinicians who are trainees, e.g., fellows, medical students or residents

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive audio recordings of clinic visits in addition to usual care over 12 months

12 months

Scheduled clinic visits at baseline, 1 week, 6 months, and 12 months

Follow-up

Participants are monitored for self-management ability, quality of life, medication adherence, and satisfaction

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Clinic visit audio recordings for self-management in older adults
• Usual Care

Trial Overview The study compares two approaches: providing patients with audio recordings of their clinic visits to help manage their health (AUDIO), versus the standard practice of giving an After Visit Summary only (Usual Care). The goal is to see if AUDIO can improve self-management in older adults with multiple health conditions including diabetes.

How Is the Trial Designed?

Group I: Audio Active Control 1 Intervention

Researchers will audio record both in-person and telehealth visits of participants in the intervention group.

Group II: Usual care Placebo Group 1 Intervention

Participants will receive Usual Care

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Vanderbilt University Medical Center

Collaborator

Trials

922

Recruited

939,000+

The University of Texas Medical Branch, Galveston

Collaborator

Trials

263

Recruited

55,400+

Published Research Related to This Trial

A pilot study involving 14 patient-clinician dyads showed that a photo-based communication intervention significantly enhanced discussions about dietary behaviors in older adults with multiple chronic conditions, with 93% of patients and 86% of clinicians expressing willingness to use this method again.

The intervention not only improved communication and information exchange during clinic visits but also positively influenced clinical recommendations and strengthened the patient-clinician relationship, suggesting it could be an effective strategy for comprehensive geriatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A photo-based communication intervention to promote diet-related discussions among older adults with multi-morbidity. Jih, J., Nguyen, A., Woo, J., et al.[2023]

The study involved 40 out of 76 eligible diabetes patients who participated in a 6-week Interactive Voice Response (IVR) peer support intervention, with 38 completing the program, indicating good feasibility and acceptability of the method.

Participants reported significant improvements in diabetes self-care self-efficacy, with 70% finding the calls helpful for managing symptoms, suggesting that peer support through IVR could enhance diabetes management and health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"I help you, and you help me": facilitated telephone peer support among patients with diabetes. Heisler, M., Piette, JD.[2018]

A study involving 42 providers and 13 focus group participants revealed that many healthcare providers are not fully familiar with Diabetes Self-Management Education and Support (DSMES), highlighting a need for better education and resources.

The focus groups emphasized the importance of clear and concise clinic notes, suggesting the use of SMART goals to enhance patient understanding and engagement in diabetes self-care, which will be incorporated into the development of the SEE-Diabetes educational aid.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SEE-diabetes, a patient-centered diabetes self-management education and support for older adults: Findings and information needs from providers' perspectives. Narindrarangkura, P., Boren, SA., Khan, U., et al.[2022]

A study involving 697 lower-income and minority patients demonstrated that high-quality health data can be reliably collected using self-administered questionnaires, even among those with literacy limitations, achieving over 84% item completion rates.

The research suggests that less expensive data collection methods, like mail-out/mail-back or hand-out/assisted questionnaires, can be effective, reducing the need for costly in-home interviews while still ensuring reliable data quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of various methods of collecting self-reported health outcomes data among low-income and minority patients. Sullivan, LM., Dukes, KA., Harris, L., et al.[2019]

The implementation of electronic health records (EHR) has introduced challenges in diabetes care, particularly for patients with limited health literacy and English proficiency, highlighting the need for safer medication prescribing practices.

Recommendations for improving patient safety include adopting standardized medication naming, enhancing communication with pharmacies, and conducting research on EHR practices in safety net healthcare systems to better serve diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Challenges of Electronic Health Records and Diabetes Electronic Prescribing: Implications for Safety Net Care for Diverse Populations. Ratanawongsa, N., Chan, LL., Fouts, MM., et al.[2021]

A significant 86% of the 111 diabetes patients experienced at least one adverse event (AE) or potential adverse event (PotAE) over a 9-month period, highlighting the prevalence of safety issues in chronic disease management.

The majority of AEs (63%) were related to medication management, and 77% of events involved patient actions, indicating that enhancing patient self-management and communication with healthcare providers is crucial for preventing these events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What happens between visits? Adverse and potential adverse events among a low-income, urban, ambulatory population with diabetes. Sarkar, U., Handley, MA., Gupta, R., et al.[2021]

Automated telephone disease management (ATDM) calls significantly improved access to self-care and dietary education for patients with diabetes, with Spanish-speaking patients showing a higher engagement (64% selection rate) compared to English speakers (36%).

Over a year, while the overall selection of messages decreased, a majority of Spanish-speaking patients continued to utilize the educational resources, indicating a strong receptiveness to ATDM for diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient education via automated calls: a study of English and Spanish speakers with diabetes. Piette, JD.[2021]

Patients with diabetes perceive greater benefits from having electronic access to their doctors' clinic notes, believing it helps them manage their medication and self-care more effectively.

The study indicates that both diabetic and non-diabetic patients view electronic access positively, but diabetic patients are significantly more likely to feel it enhances their health management, suggesting that healthcare providers should promote the use of patient portals for chronic disease management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Will use of patient portals help to educate and communicate with patients with diabetes? Jackson, SL., DesRoches, CM., Frosch, DL., et al.[2022]

In a study analyzing 19 general practitioner consultations about type 2 diabetes and cardiovascular diseases, it was found that there is a significant disconnect between the self-management actions patients are expected to take during and after consultations, leading to feelings of overwhelm among patients.

The discussions around lifestyle changes were often subjective and relied on patient recall, indicating a need for better digital support tools to help patients manage their health more effectively after consultations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How general practitioners and patients discuss type 2 diabetes mellitus and cardiovascular diseases concerns during consultations: Implications for digital health. Rohilla, U., Ramarao, JP., Lane, J., et al.[2023]

Sharing personalized clinical information with patients with type 2 diabetes before their outpatient consultations increased their engagement with the information, as evidenced by higher rates of sharing the booklet with others and bringing it to the clinic.

Despite the increased engagement with the intervention booklet, there were no significant improvements in patient involvement during consultations, self-efficacy in diabetes management, or glycaemic control among the different groups, indicating that simply providing information may not directly enhance health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of sharing personalised clinical information with people with type 2 diabetes prior to their consultation: A pilot randomised controlled trial. O'Donnell, M., Alvarez-Iglesias, A., McGuire, BE., et al.[2022]

A study involving 151 adults with type 2 diabetes showed that both online and telephone care management significantly improved hemoglobin A1c (A1c) levels over 12 months, with declines of 0.32% and 0.36% per quarter, respectively.

Interestingly, the Web training group, which received only online resources without direct care management, also achieved a significant A1c reduction, suggesting that internet access and training alone can be effective for managing poorly controlled diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized comparison of online- and telephone-based care management with internet training alone in adult patients with poorly controlled type 2 diabetes. McMahon, GT., Fonda, SJ., Gomes, HE., et al.[2022]

An automated telephone reminder system (ATRS) was successfully implemented for 253 adults with diabetes, with 84% registering and 95% receiving at least one reminder over 7.5 months.

Despite high engagement with the ATRS, there was no significant change in medication adherence or appointment attendance, indicating that while the system is feasible, its clinical benefits remain uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated telephone reminder messages can assist electronic diabetes care. Mollon, B., Holbrook, AM., Keshavjee, K., et al.[2008]

In a survey of 1588 older adults with diabetes, both the provision of information by physicians and participatory decision-making were linked to improved diabetes self-management and glycemic control, indicating their importance in chronic disease management.

Specifically, while provision of information was crucial for medication adherence and foot care, participatory decision-making was more strongly associated with lifestyle changes like diet and exercise, highlighting the need for active patient involvement in complex self-care behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does physician communication influence older patients' diabetes self-management and glycemic control? Results from the Health and Retirement Study (HRS). Heisler, M., Cole, I., Weir, D., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04344301

The Impact of Sharing Audio Recorded Clinic Visits on Self ... 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 ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0738399124004415

The feasibility of sharing digital audio-recordings of clinic ... Audio recording of primary care visits was shared with older adults with multimorbidity. · Sharing visit recordings was found to be feasible and acceptable.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11708993/

Audio-Based Care for Managing Diabetes in Adults We compared the effectiveness of audio-based care, as a replacement or a supplement to usual care, for managing diabetes.

4. withpower.com withpower.com/trial/phase-diabetes-4-2023-10ea4

Audio Recordings for Diabetes Management (REPLAY Trial) 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 ...

5. news.vumc.org news.vumc.org/2022/10/06/audio-recordings-could-benefit-older-adults-following-clinic-visits/

Audio recordings could benefit older adults following clinic ... “Studies have shown that when patients receive an audio recording of a visit, 71% listen and 68% share it with a caregiver, resulting in greater ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05824572/the-effect-of-clinic-visit-audio-recordings-for-self-management-in-older-adults

The Effect of Clinic Visit Audio Recordings for Self ... 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 ...