Shared Medical Appointments for Type 2 Diabetes

Recruiting at 1 trial location

Overseen By Fatima Aguilar

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Los Angeles

Disqualifiers: Non-verbal, others

Compensation: Varies

Number of Visits: 4

74 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to learn about if shared medical appointment is an acceptable way to deliver care to youth with type 2 diabetes. The main question\[s\] it aims to answer are: * Design four group activities centered around nutrition therapy, peer interactions, exercise and stress management. * Design the clinical workflow for implementation phase. Participants will attend quarterly clinic appointments and group activities and take surveys. Researchers will compare this intervention to standard of care.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Are shared medical appointments safe for people with diabetes?

The research on shared medical appointments for diabetes does not report any specific safety concerns, suggesting they are generally safe for use in humans. ^{1 2 3 4 5}

How do shared medical appointments differ from other treatments for type 2 diabetes?

Shared medical appointments are unique because they involve group consultations where multiple patients receive care and education from healthcare providers at the same time. This approach maximizes resources and allows for integrated care and patient education in a single session, which can improve diabetes management and patient outcomes. ^{1 2 4 6 7}

What data supports the effectiveness of the treatment Shared Medical Appointments for Type 2 Diabetes?

Research shows that shared medical appointments can improve blood sugar control and diabetes management by providing group consultations where patients receive medical care and education together. These appointments have been found to enhance diabetes knowledge and promote healthier behaviors, although more studies are needed to compare them directly with standard care. ^{1 2 5 6 7}

Who Is on the Research Team?

Lily C Chao

Principal Investigator

Children's Hospital Los Angeles

Are You a Good Fit for This Trial?

This trial is for young people with type 2 diabetes and hypertension. Participants will need to attend quarterly clinic appointments, engage in group activities, and complete surveys. Specific eligibility details are not provided.

Inclusion Criteria

Receives type 2 diabetes care at either CHLA or UCSF

Exclusion Criteria

Unwillingness to wear blinded CGM devices (2 weeks at baseline and at the conclusion of the study)

I am unwilling to complete the study surveys.

I cannot speak or join in group activities.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Design and implement four group activities centered around nutrition therapy, peer interactions, exercise, and stress management. Design the clinical workflow for the Team Clinic.

5 months

Quarterly clinic appointments and group activities

Monitoring

Participants' glycemic control and other health metrics are monitored using various questionnaires and surveys.

1 year

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the main intervention phase.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Shared Medical Appointments

Trial Overview The study is testing if shared medical appointments can be a good way to provide care compared to the usual one-on-one visits (standard of care). It looks at whether this approach is acceptable and improves psychosocial outcomes.

How Is the Trial Designed?

Group I: Shared Medical Appointment Active Control 1 Intervention

Group II: Standard Care Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Children's Hospital Los Angeles

Lead Sponsor

Trials

257

Recruited

5,075,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

Published Research Related to This Trial

Shared medical appointments (SMAs) significantly improved key health indicators for diabetes patients, including a reduction in hemoglobin A1c levels by an average of 0.55 percentage points and systolic blood pressure by 5.2 mmHg, based on a review of 17 studies.

Despite these improvements in biophysical outcomes, the effectiveness of SMAs on LDL cholesterol levels was not significant, and there was not enough data to assess their impact on patient experience or healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shared medical appointments for patients with diabetes mellitus: a systematic review. Edelman, D., Gierisch, JM., McDuffie, JR., et al.[2022]

Diabetes shared medical appointments (SMAs) significantly improved A1c levels in participants compared to usual care, with reductions of up to 0.53% for those attending at least half of the SMAs, based on a study involving 1537 adults with type 2 diabetes.

While SMAs showed immediate benefits in glycemic control, these improvements were not sustained at the 12-month follow-up, indicating a need for further research on long-term strategies to maintain these gains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Effectiveness of Diabetes Shared Medical Appointments (SMAs) as Implemented in Five Veterans Affairs Health Systems: a Multi-site Cluster Randomized Pragmatic Trial. Heisler, M., Burgess, J., Cass, J., et al.[2022]

A systematic review of nine randomized trials involving various chronic illnesses (excluding diabetes and mental health) found that shared medical appointments do not negatively impact patient quality of life, knowledge, or satisfaction compared to usual care.

Patients attending shared medical appointments experienced fewer hospital admissions, suggesting potential benefits for healthcare systems, although more rigorous studies with larger sample sizes are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shared medical appointments for patients with a nondiabetic physical chronic illness: A systematic review. Kelly, F., Liska, C., Morash, R., et al.[2019]

Patients involved in shared medical appointments showed notable enhancements in their blood sugar levels, indicating improved glycemic control.

This approach suggests that collaborative care models may be effective in managing diabetes and improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shared Medical Appointments and Their Effects on Achieving Diabetes Mellitus Goals in a Veteran Population. Tardi, A., Kapadia, S., Kurpius, M., et al.[2020]

Shared medical appointments (SMAs) may improve glycemic outcomes and diabetes knowledge in patients with type 2 diabetes mellitus (T2DM), based on a review of 19 studies.

However, the effectiveness of SMAs compared to standard care is still unclear due to limited studies and variability in study designs, indicating a need for larger, more standardized research to evaluate their practicality in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shared Medical Appointments May Be Effective for Improving Clinical and Behavioral Outcomes in Type 2 Diabetes: A Narrative Review. Menon, K., Mousa, A., de Courten, MP., et al.[2019]

Shared medical appointments (SMA) for 30 male veterans with diabetes led to significant improvements in key health metrics, including A1c, blood pressure, and cholesterol levels over a 6-month period, with no hospitalizations reported.

Veteran satisfaction with the SMA approach increased significantly, highlighting its potential as an effective intervention for managing chronic conditions like diabetes in the veteran population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation and Evaluation of Shared Medical Appointments in Veterans With Diabetes: A Quality Improvement Study. Omogbai, T., Milner, KA.[2019]

Shared medical appointments can improve education and outcomes for patients with chronic conditions, particularly among the elderly, as shown in several trials.

The effectiveness of shared medical appointments compared to traditional care remains uncertain, as it is unclear if benefits arise from the unique format or simply from increased provider interaction and time spent with patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of shared medical appointments in the care of the elderly. Cherniack, EP.[2013]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Shared medical appointments for patients with diabetes mellitus: a systematic review. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Evaluating the Effectiveness of Diabetes Shared Medical Appointments (SMAs) as Implemented in Five Veterans Affairs Health Systems: a Multi-site Cluster Randomized Pragmatic Trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Shared medical appointments for patients with a nondiabetic physical chronic illness: A systematic review. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Shared Medical Appointments and Their Effects on Achieving Diabetes Mellitus Goals in a Veteran Population. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Shared Medical Appointments May Be Effective for Improving Clinical and Behavioral Outcomes in Type 2 Diabetes: A Narrative Review. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Implementation and Evaluation of Shared Medical Appointments in Veterans With Diabetes: A Quality Improvement Study. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

The use of shared medical appointments in the care of the elderly. [2013]