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

Trial Summary

What is the purpose of this trial?

The overarching goal of the proposed research is to prepare the clinical pharmacist intervention for sustainable implementation and dissemination. Because the effectiveness of the intervention has already been demonstrated in a NIH Stage Model IV trial, the investigators propose an Effectiveness-Implementation Type 3 Hybrid design, in which the primary focus is on testing different implementation methods, while secondarily observing clinical effects. The investigators' overarching hypothesis is to identify the most impactful elements of a behavioral theory-informed recruitment approach, which can be replicable across clinical settings. Accordingly, the investigators propose to perform testing of a behaviorally-informed recruitment approaches in a community-based setting. Like the previous Tele-Pharmacy Intervention to Improve Treatment Adherence (STIC2IT) trial (NCT02512276), participants will be English or Spanish speaking adults ≥18 years of age identified through the electronic health record (EHR) as having poor disease control and/or poor medication adherence for diabetes. The primary care physicians of eligible patients identified through the EHR will be contacted to opt-out any patients they wish not to be included. Patients will then be randomized to each of the following conditions, such that there will be 8 total arms: (1) inclusion of a mailer primer (yes/no), (2) the most successful recruitment letter from the preliminary study using prospect theory (versus the control letter), and (3) intensity of the intervention outreach (4 calls vs. 2 calls). The investigators plan to enroll 584 participants who meet the inclusion criteria, with 73 patients per each of the 8 study arms. Patients across all arms who agree to be scheduled will receive an appointment with one of the clinical pharmacists within the established BMC pharmacist program. The primary outcome will be completion of a clinical pharmacist appointment within 8 weeks after randomization. Key secondary outcomes will include scheduled visit rates, no-show rates for scheduled appointments, medication adherence over the 3-month follow-up, and clinical outcomes, including HbA1c levels measured using EHR data in the 3 months after randomization. The medication adherence and clinical outcomes will be used for the Aim 2 evaluation.

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.

What data supports the effectiveness of the treatment Behavioral Medication Adherence Interventions for diabetes?

Research shows that improving medication adherence through behavioral interventions can lead to better health outcomes for people with diabetes. These interventions often include strategies like positive reinforcement and simplifying treatment plans, which help patients stick to their medication schedules and improve their quality of life. ^{1 2 3 4 5}

Is it safe to participate in behavioral interventions for diabetes?

Behavioral interventions for diabetes, which focus on improving lifestyle habits and medication adherence, are generally considered safe for humans. These interventions have been used to support better health outcomes in people with diabetes, and no significant safety concerns have been reported in the research. ^{6 7 8 9 10}

How is the Behavioral Medication Adherence Interventions treatment for diabetes unique?

This treatment is unique because it focuses on changing patient behavior to improve medication adherence, rather than just increasing knowledge about diabetes. It emphasizes communication between patients and healthcare providers and considers individual and community factors to optimize behavior change. ^{4 6 7 11 12}

Research Team

Niteesh K Choudhry, MD, PhD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

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 18 years old or older.

I speak English or Spanish.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Effective interventions to improve medication adherence in Type 2 diabetes: a systematic review. [2021]

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

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

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

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

4. Netherlands 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. [2022]

5. Bosnia and Herzegovina pubmed.ncbi.nlm.nih.gov

ADHERENCE AND QUALITY OF LIFE IN PATIENTS WITH TYPE II DIABETES MELLITUS IN NORTHERN GREECE. [2020]

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

Behavioral interventions for diabetes self-management. [2007]

7. England pubmed.ncbi.nlm.nih.gov

Effective strategies for encouraging behavior change in people with diabetes. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Acceptance-based therapy: the potential to augment behavioral interventions in the treatment of type 2 diabetes. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Adherence therapy for adults with type 2 diabetes: a feasibility study of a randomized controlled trial. [2023]

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

Behavioral assessment and intervention in pediatric diabetes. [2007]

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

The role of behavior in diabetes care. [2019]

12. Spain pubmed.ncbi.nlm.nih.gov

Assessment of patient knowledge of diabetic goals, self-reported medication adherence, and goal attainment. [2022]