What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes, such as lifestyle interventions, metformin, and insulin therapy, have varying side effects. Lifestyle changes generally have minimal physical side effects but require strong patient commitment. Metformin often causes gastrointestinal issues like nausea and diarrhea. Insulin therapy can lead to hypoglycemia and weight gain. Emotional support programs, like the Telephonic Layperson-Delivered Empathy and Relationship-Focused Program, enhance patient engagement and mental health, potentially improving overall diabetes management without direct physical side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Type 2 Diabetes that focus on improving patient engagement and emotional support. These include collaborative care models and telemedicine interventions, which have shown efficacy in managing diabetes and improving mental health outcomes. While specific drugs are not the primary focus of these interventions, they often complement pharmacological treatments such as metformin, GLP-1 receptor agonists, and insulin. These comprehensive approaches aim to enhance patient self-management, adherence to treatment, and overall quality of life.

What other types of research exist?

Promising alternatives for Type 2 Diabetes patients include: 1) eHealth interventions with digital lifestyle coaching, which provide personalized support and community collaboration; 2) Cognitive Behavioral Therapy (CBT) delivered through online platforms, which can improve both diabetes management and mental health; 3) Mind-Body Therapies, such as mindfulness-based stress reduction, which have shown benefits in managing diabetes-related stress and improving glycemic control; 4) Automated text messaging programs, like the SmokeFreeTXT program adapted for diabetes, offering motivational support and behavioral change suggestions; 5) Telemedicine services for comprehensive diabetes management, including remote monitoring and virtual consultations with healthcare providers.

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Behavioral Intervention

Empathy-Focused Support Calls for Diabetes (EIA-Diabetes Trial)

N/A

Waitlist Available

Led By Maninder Kahlon, PhD

Research Sponsored by University of Texas at Austin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Moderate to severe cognitive impairment

Having diagnosis of end-stage renal disease or serious mental illness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a phone-based support program for diabetes patients at a health center. Trained laypeople will call patients to offer emotional support and practical advice to help them manage their condition better.

Who is the study for?

This trial is for patients with Type 2 Diabetes who have visited Lone Star Circle of Care in the past year and have high HbA1c levels. They must be willing to complete a mental health questionnaire (PHQ-9). People with severe cognitive issues, serious mental illness, end-stage renal disease, current pregnancy, low HbA1c levels, cancer treatment or on certain immune therapies can't join.

What is being tested?

The study tests an empathy-focused phone program's ability to help manage diabetes and improve mental health against usual care at a Federally Qualified Health Center. Participants are randomly placed into two groups: one receives the empathy calls while the other gets standard materials only.

What are the potential side effects?

Since this intervention involves telephonic support rather than medication, traditional side effects are not expected. However, participants may experience emotional discomfort or distress during sensitive discussions about their condition.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have significant memory or thinking problems.

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I have been diagnosed with end-stage kidney disease or a serious mental illness.

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I am on prednisone or immunosuppressants after an organ transplant.

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I am currently pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hemoglobin A1C (HbA1c)

Secondary study objectives

Anxiety as measured by scores on the Generalized Anxiety Disorder 7-item (GAD-7)

Depression as measured by scores on the Patient Health Questionnaire 9-item (PHQ-9)

Diabetes Self-Efficacy measured by scores on the Stanford Self-Efficacy for Diabetes Scale 8-item

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Program armExperimental Treatment1 Intervention

Usual Care+ Phase 1 (6 months, months 1-6), Program. Includes empathetic communications (phone \& letter), health-promoting incentives, educational materials. Phase 2 (6 months, months 7-12) No Program. During this follow-up period they will receive monthly SMS texts with customized messages encouraging health promoting behaviors.

Group II: Control armExperimental Treatment1 Intervention

Usual Care+ Phase 1 (6 months, months 1-6), No Program. Phase 2 (6 months, months 7-12) Material components of program including health-promoting incentives and educational materials.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Empathy in Action for life with diabetes.

2022

N/A

~260

Control Phase 2 Materials Only

2022

N/A

~260

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Type 2 Diabetes include lifestyle interventions, pharmacotherapy, and emotional support programs. Lifestyle interventions, such as diet and exercise, improve glycemic control by enhancing insulin sensitivity and promoting weight loss. Pharmacotherapy, including metformin and insulin sensitizers, works by reducing hepatic glucose production and improving peripheral glucose uptake. Emotional support programs, like the Telephonic Layperson-Delivered Empathy and Relationship-Focused Program, enhance patient engagement and mental health, which can lead to better adherence to treatment plans and improved glycemic control. These mechanisms are crucial as they address both the physiological and psychological aspects of diabetes management, leading to more comprehensive care for patients.

Comparing a Social and Communication App, Telephone Intervention, and Usual Care for Diabetes Self-Management: 3-Arm Quasiexperimental Evaluation Study.A Mobile App to Improve Self-Management of Individuals With Type 2 Diabetes: Qualitative Realist Evaluation.The experiences of and meaning for women living and coping with type 2 diabetes: a systematic review of qualitative evidence.