Behavioral Interventions for Diabetes

(STIC2IT-2 Trial)

Overseen By Niteesh K Choudhry, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Must be taking: Oral glucose-lowering

Disqualifiers: Terminal conditions

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

584 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the best ways to encourage people with diabetes to adhere to their medication plans. Researchers are testing different methods, such as sending letters or making phone calls, to determine which ones effectively prompt patients to visit a clinical pharmacist. The trial seeks English or Spanish-speaking adults with diabetes who struggle with medication adherence and have poor control over their condition. Participants will try various approaches, known as Behavioral Medication Adherence Interventions, to identify which ones improve medication adherence and health outcomes. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative strategies that could enhance diabetes management for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on improving medication adherence, so it's likely you will continue your current diabetes medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that programs helping people with diabetes adhere to their medication regimens are generally safe. For example, studies have found that pharmacist-led programs often yield positive results without major safety issues. These programs aim to improve patients' adherence to medication plans, enhancing diabetes management.

One review examined 59 studies and found that pharmacist-led programs improved patient outcomes. This indicates that the programs are effective and manageable for patients. No major unwanted side effects were reported in these studies.

The trial's "Not Applicable" phase indicates that the treatment is considered safe for widespread testing. This phase focuses on optimizing program use rather than testing its safety.

In summary, current evidence supports that these programs are safe and effective for managing diabetes without significant risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Behavioral Medication Adherence Interventions because they offer a fresh approach to managing diabetes, a condition traditionally treated with medication and lifestyle changes. Unlike standard treatments that focus solely on medication and diet, these interventions explore how behavioral techniques, like personalized communication through postcards and calls, can enhance medication adherence. By tailoring interactions through different combinations of communication methods, the trial aims to uncover the most effective strategies for encouraging patients to stick to their treatment plans. This innovative approach could lead to more personalized, supportive care for individuals with diabetes, potentially improving their health outcomes and quality of life.

What evidence suggests that this trial's behavioral medication adherence interventions could be effective for diabetes?

This trial will evaluate various behavioral medication adherence interventions for diabetes. Studies have shown that certain programs can help people with diabetes take their medication more regularly. For example, a review of different studies found that almost half of these programs succeeded. Another study found that programs based on understanding behavior helped older adults with type 2 diabetes maintain their medication schedules. Taking medication as prescribed links to better diabetes management, such as lower blood sugar levels. Overall, these programs have effectively helped patients manage their diabetes better. ^{1 3 6 7 8}

Who Is on the Research Team?

Niteesh K Choudhry, MD, PhD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for English or Spanish speaking adults over 18 who have diabetes, are treated by a BMC primary care provider, and struggle with taking their medication as prescribed. They should also show signs of poor diabetes control. Patients will be excluded if their doctor thinks they shouldn't participate.

Inclusion Criteria

I am currently under the care of a BMC primary care provider.

I haven't consistently taken my diabetes medication as prescribed in the last 6 months.

My condition is getting worse.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Intervention

Participants are randomized into 8 arms to test different recruitment methods and intervention outreach intensities

8 weeks

1 appointment with a clinical pharmacist

Follow-up

Participants are monitored for medication adherence and clinical outcomes, including HbA1c levels

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral Medication Adherence Interventions

Trial Overview

The study tests different ways to get patients involved in a program that helps them stick to their diabetes medication. It compares the effects of receiving different types of recruitment letters and varying numbers of phone calls (either two or four) on making an appointment with a clinical pharmacist.

How Is the Trial Designed?

Group I: Arm 1 Active Control 3 Interventions

Post card; control letter; 2 calls

Group II: Arm 2 Active Control 3 Interventions

Post card; control letter; 4 calls

Group III: Arm 8 Active Control 2 Interventions

No post card; behavioral letter; 4 calls

Group IV: Arm 3 Active Control 3 Interventions

Post card; behavioral letter; 2 calls

Group V: Arm 4 Active Control 3 Interventions

Post card; behavioral letter; 4 calls

Group VI: Arm 5 Active Control 2 Interventions

No post card; control letter; 2 calls

Group VII: Arm 6 Active Control 2 Interventions

No post card; control letter; 4 calls

Group VIII: Arm 7 Active Control 2 Interventions

No post card; behavioral letter; 2 calls

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Boston Medical Center

Collaborator

Trials

410

Recruited

890,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

Published Research Related to This Trial

Effective diabetes management requires not only medical treatment but also a focus on changing patient behavior to improve compliance with treatment regimens.

The paper reviews current strategies for directly influencing behavior related to diabetes management and enhancing patient adherence to therapy, highlighting the importance of integrating physiological and behavioral approaches in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of behavior in diabetes care. Surwit, RS., Scovern, AW., Feinglos, MN.[2019]

Out of 27 studies on medication adherence in Type 2 diabetes, only 13 demonstrated a significant improvement in adherence, highlighting variability in intervention effectiveness.

The study found that differences in study designs and adherence measures complicate the identification of effective interventions, suggesting a need for more tailored approaches to improve medication adherence and overall diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective interventions to improve medication adherence in Type 2 diabetes: a systematic review. Williams, JL., Walker, RJ., Smalls, BL., et al.[2021]

In a study of 108 patients with type II diabetes, good adherence to diet and blood testing was observed, but this did not translate to high quality of life scores, indicating a disconnect between treatment adherence and overall well-being.

The study found that treatment type significantly influenced adherence to blood tests, and marital status impacted mental health, suggesting that personalized interventions could enhance treatment adherence and improve quality of life for diabetes patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ADHERENCE AND QUALITY OF LIFE IN PATIENTS WITH TYPE II DIABETES MELLITUS IN NORTHERN GREECE. Zioga, E., Kazakos, K., Dimopoulos, E., et al.[2020]

Multifaceted and individualized behavioral interventions for diabetes self-management, especially those lasting six months or longer, show modest improvements in diabetes-related outcomes.

Current challenges include enhancing access to these interventions and addressing the social and environmental factors that affect behavior change, highlighting areas for future research and care improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral interventions for diabetes self-management. Whittemore, R.[2007]

Lifestyle changes, supported by standard behavioral interventions and cognitive behavioral therapies, are crucial in managing type 2 diabetes and can enhance adherence to healthy behaviors and medication regimens.

The review suggests that acceptance-based therapies (ABTs) could be a promising new approach for diabetes management, but further research is needed to confirm their effectiveness in improving glucose control and promoting lifestyle changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance-based therapy: the potential to augment behavioral interventions in the treatment of type 2 diabetes. Cardel, MI., Ross, KM., Butryn, M., et al.[2022]

This study will evaluate a patient-centered intervention designed to improve medication adherence in 50 English-speaking diabetes patients, focusing on health literacy and psychosocial support over 6 sessions.

The goal is to determine if this intervention, compared to usual care, can effectively enhance medication adherence and diabetes control, as measured by participant questionnaires and interviews.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and rationale of a mixed methods randomized control trial: ADdressing Health literacy, bEliefs, adheRence and self-Efficacy (ADHERE) program to improve diabetes outcomes. Shiyanbola, OO., Walbrandt Pigarelli, DL., Unni, EJ., et al.[2022]

Integrating behavioral interventions, particularly positive reinforcement, into diabetes care can significantly improve health outcomes for both youth and adults, yet these methods are often underutilized in clinical practice.

Current medical system constraints hinder the consistent application of effective behavioral principles in diabetes management, highlighting the need for increased awareness and implementation of these strategies in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes and Behavioral Learning Principles: Often Neglected yet Well-Known and Empirically Validated Means of Optimizing Diabetes Care Behavior. Stoeckel, M., Duke, D.[2018]

In a study of 149 adult patients with diabetes, only a small percentage reported knowledge of their therapeutic goals for LDL-C (14%), blood pressure (34%), and A1C (18%), indicating a significant gap in patient education.

Nearly half of the patients (48%) were non-adherent to their medication, with forgetfulness (34%) and cost (14%) being the main reasons, highlighting the need for healthcare providers to emphasize the importance of medication adherence during every patient visit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of patient knowledge of diabetic goals, self-reported medication adherence, and goal attainment. Whitley, HP., Fermo, JD., Ragucci, K., et al.[2022]

The review highlights the importance of addressing behavioral barriers in managing diabetes in children and adolescents, emphasizing that effective interventions can improve treatment adherence and metabolic control.

Validated assessment methods for diabetes-specific behavioral issues, such as fears, social skills, and stressors, are crucial for tailoring interventions that support better health outcomes in young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral assessment and intervention in pediatric diabetes. Wysocki, T.[2007]

Effective behavioral management strategies for diabetes can significantly improve health outcomes, emphasizing the importance of tailored recommendations and teamwork in care.

Factors such as health literacy, community support, and co-occurring issues like eating and mood disorders play a crucial role in facilitating behavior change among individuals with diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective strategies for encouraging behavior change in people with diabetes. Hood, KK., Hilliard, M., Piatt, G., et al.[2019]

Improving adherence to treatment in type 2 diabetes is crucial for better health outcomes, as many patients struggle with complex regimens and lifestyle changes required for managing their condition.

Effective strategies to enhance adherence include patient education, simplifying treatment plans, monitoring progress, and providing ongoing support, rather than just adjusting medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to treatment: the key for avoiding long-term complications of diabetes. Lerman, I.[2022]

The study assessed the feasibility of conducting a randomized controlled trial (RCT) of adherence therapy for people with type 2 diabetes, finding that 71% of participants in the adherence therapy group completed the treatment, indicating potential effectiveness in promoting medication adherence.

Out of 78 screened individuals, only 13 consented to participate, highlighting challenges in recruitment and the need for improved strategies to ensure better understanding and retention of participants in future trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence therapy for adults with type 2 diabetes: a feasibility study of a randomized controlled trial. Alenazi, F., Peddle, M., Bressington, D., et al.[2023]

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