Self-Management Workbook for Diabetes

Overseen By Catherine Park, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Pregnancy, Anemia, Hemoglobinopathy, others

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

Compensation: Varies

Number of Visits: Unknown

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goals of this study are to: 1. Co-develop a user-friendly word game-based workbook format for patients with diabetes to understand how to manage their diabetes. For this study, the first section of the workbook will be developed to teach carbohydrate management. 2. Assess the feasibility and acceptability of the workbook. 3. Understand the implementation challenges that will be important for improving the workbook and preparing it for larger-scale effectiveness research. Participants will be asked to: * Complete the workbook during their waiting time in the clinic or at home. * Engage in word games designed to teach diabetes management vocabulary and concepts. * Attend follow-up sessions to assess changes in self-efficacy and glycemic control.

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 seems focused on using a workbook to help manage diabetes, so it's unlikely that medication changes are required.

Is the Diabetes Self-Management Workbook safe for humans?

The research does not provide specific safety data for the Diabetes Self-Management Workbook, but it highlights the importance of educational interventions for health professionals to improve patient safety in diabetes care. ^{1 2 3 4 5}

How does the Diabetes self-management workbook treatment differ from other diabetes treatments?

The Diabetes self-management workbook is unique because it focuses on empowering patients to manage their diabetes through personalized self-management strategies, rather than relying solely on medication. It emphasizes the importance of individual experiences and perceptions in developing effective self-care routines, which can lead to better long-term health outcomes. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Diabetes self management workbook?

Research shows that successful diabetes self-management often involves education, feedback, and support from healthcare professionals, which are key components of self-management workbooks. These elements help patients make necessary lifestyle changes and improve their ability to manage diabetes effectively. ^{11 12 13 14 15}

Who Is on the Research Team?

Catherine Park, MD

Principal Investigator

Emory University

Saria Hassan, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for individuals with diabetes who are interested in learning how to manage their condition through a workbook. Participants should be willing to complete the workbook either at the clinic or at home and attend follow-up sessions.

Inclusion Criteria

Patients: adult with diabetes and patient at the Midtown Clinic

I don't have anemia, liver, kidney disease, or blood disorders affecting my hemoglobin.

I am a caregiver for someone with diabetes.

Exclusion Criteria

Focus group exclusion:

Pregnancy

I am not willing to participate in group discussions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Workbook Development and Use

Participants co-develop and complete a word game-based workbook to enhance diabetes self-efficacy

3 months

Workbook can be completed during clinic visits or at home

Follow-up

Participants attend follow-up sessions to assess changes in self-efficacy and glycemic control

3 months

Pre test and post test assessments

What Are the Treatments Tested in This Trial?

Interventions

• Diabetes self management workbook

Trial Overview The study is testing a new word game-based workbook designed to help patients understand carbohydrate management as part of their diabetes care. The effectiveness, user-friendliness, and potential challenges of this educational tool will be evaluated.

How Is the Trial Designed?

Group I: Diabetes self management Experimental Treatment 1 Intervention

Eligible participants will utilize the workbook for a span of 3 months

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Georgia Center for Diabetes Translation Research

Collaborator

Trials

5

Recruited

200+

Published Research Related to This Trial

In a study involving 5,457 low-income adults with diabetes, patient report cards were well-received but did not lead to improved clinical outcomes in glycemic control, lipid levels, or blood pressure.

However, providing targeted, patient-level performance feedback to healthcare providers resulted in a significant increase in the percentage of patients achieving glycemic control, indicating that personalized feedback can enhance provider performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of tailored diabetes registry report cards on measures of disease control: a nested randomized trial. Fischer, HH., Eisert, SL., Durfee, MJ., et al.[2023]

Ongoing patient education and feedback are essential for effective self-management in patients with Type 2 Diabetes Mellitus (T2DM), highlighting the importance of continuous support.

An individualized program that includes an interprofessional team of healthcare professionals and utilizes positive feedback and motivational strategies significantly enhances patient engagement and management of their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient education and monitoring recommendations for the use of glucagon-like peptide-1 receptor agonists. Haines, ST.[2015]

A new diagnostic tool was developed for pharmacists to assess diabetes patients' readiness to adhere to diet regimens, utilizing the Transtheoretical Model (TTM) to measure stages of change, decisional balance, and self-efficacy among 193 participants.

The study found that TTM measures effectively identified factors that facilitate or hinder diet adherence, but highlighted the importance of considering social desirability bias in self-reported diet adherence among patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient decision making: strategies for diabetes diet adherence intervention. Kavookjian, J., Berger, BA., Grimley, DM., et al.[2015]

Patients with diabetes are responsible for 99% of their own care, highlighting the need for effective support systems and education from healthcare providers.

To improve diabetes self-management, healthcare practices must redefine the roles of health professionals and patients, and redesign systems to facilitate long-term support and education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changing office practice and health care systems to facilitate diabetes self-management. Funnell, MM., Anderson, RM.[2022]

A pilot intervention aimed at helping low-income, Hispanic patients with diabetes connect to community resources showed a high demand for assistance, with all participants requesting at least one referral for services like food and housing support.

Although the intervention did not result in significant changes in diabetes self-care or self-efficacy, a notable 50% of patients followed up on their referrals, indicating that connecting patients to existing resources can be an effective and low-cost strategy for improving their overall support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinic-based pilot intervention to enhance diabetes management for elderly Hispanic patients. Nguyen, AL., Angulo, M., Haghi, LL., et al.[2020]

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]

A study of 99 insulin-treated diabetic patients revealed that specific precautions, such as reviewing prescriptions and adhering to diet, significantly reduced treatment errors, highlighting the importance of patient engagement in their own care.

Female patients were found to be more diligent in following blood glucose monitoring instructions and using pillboxes, while male patients were more likely to carry allergy information, indicating gender differences in safety practices among diabetic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[What do diabetic patients and what should they do to avoid errors in the course of treatment?]. Mira, JJ., Lorenzo, S., Vitaller, J., et al.[2015]

Educational interventions for healthcare professionals, including a 6-hour standardized course, significantly improved their attitudes and motivation towards monitoring diabetes, which is crucial for patient safety.

The study suggests that these interventions can enhance the control of diabetes in patients, as measured by HbA1c levels, although the specific outcomes on patient control were not detailed in the abstract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety during the monitoring of diabetic patients: trial teaching course on health professionals and diabetics - SEGUDIAB study. Cabré, JJ., Ripoll, M., Hernández, JM., et al.[2021]

A comprehensive analysis of the National Reporting and Learning System database revealed that patient safety incidents involving insulin are common and lead to significant distress for individuals with diabetes and their families, highlighting a critical area for improvement in diabetes care.

The article discusses ongoing efforts by the National Patient Safety Agency and partner organizations aimed at reducing insulin-related errors, indicating a proactive approach to enhancing patient safety in diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin, hospitals and harm: a review of patient safety incidents reported to the National Patient Safety Agency. Cousins, D., Rosario, C., Scarpello, J.[2021]

A significant increase in unintentional therapeutic errors involving insulin was observed over a 10-year period, with a 495% rise in annual incidence, particularly affecting adults over 40 years old and predominantly women.

Most of these errors occurred in non-healthcare settings, especially during late evening hours, highlighting the need for better management strategies and the importance of poison control centers as a resource for affected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unintentional therapeutic errors involving insulin in the ambulatory setting reported to poison centers. Spiller, HA., Borys, DJ., Ryan, ML., et al.[2011]

Both generic and diabetes-specific self-management programs led to significant improvements in self-management knowledge and skills, as well as reductions in depression among 458 participants over a 12-week follow-up period.

Younger participants with higher self-efficacy and better health-related quality of life (HRQOL) showed the most improvement, highlighting the need to encourage participation from individuals with lower socio-economic status to avoid worsening health inequalities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management programs conducted within a practice setting: who participates, who benefits and what can be learned? Packer, TL., Boldy, D., Ghahari, S., et al.[2022]

Effective diabetes management heavily relies on patients' ability to self-manage their symptoms, which is crucial for achieving positive health outcomes and improving quality of life.

Utilizing a social ecological model of behavior change can help healthcare providers implement multiple-level interventions that support and sustain self-management behaviors in diabetes patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustaining self-management in diabetes mellitus. Mitchell-Brown, F.[2019]

Diabetes conversation maps (CMs) were found to be an effective method for diabetes self-management education, leading to significant improvements in knowledge and attitudes compared to traditional group education (TE) among 21 participants.

Both education methods resulted in significant decreases in glycated hemoglobin (A1C) levels after 3 months, indicating that both approaches can effectively help manage diabetes, but CMs may enhance the educational experience and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Impact of Diabetes Self-Management Education Methods on Knowledge, Attitudes and Behaviours of Adult Patients With Type 2 Diabetes Mellitus. Adam, L., O'Connor, C., Garcia, AC.[2022]

The study developed a Diabetes Self-Management Model (DSMM) based on interviews with 18 adults with Type I diabetes, highlighting that self-management involves sequential phases influenced by personal factors and monitoring activities.

Participants emphasized the importance of individualized regimens tailored to their personal experiences, suggesting that effective diabetes management is not one-size-fits-all but rather requires adaptation to what works best for each individual.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An experiential model of learning diabetes self-management. Price, MJ.[2017]

A systematic review of 11 studies involving 1073 participants found that individual empowerment strategies for diabetes management, such as consultations and educational materials, did not lead to significant reductions in HbA1c levels, which is a key measure of blood sugar control.

While these strategies did show some positive effects on psychosocial factors like self-efficacy and quality of life, the lack of impact on HbA1c suggests that these approaches need to be reevaluated to enhance their effectiveness in managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of individual strategies for the empowerment of patients with diabetes mellitus: A systematic review with meta-analysis. Aquino, JA., Baldoni, NR., Flôr, CR., et al.[2022]

Citations

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

The impact of tailored diabetes registry report cards on measures of disease control: a nested randomized trial. [2023]

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

Patient education and monitoring recommendations for the use of glucagon-like peptide-1 receptor agonists. [2015]

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

Patient decision making: strategies for diabetes diet adherence intervention. [2015]

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

Changing office practice and health care systems to facilitate diabetes self-management. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

A clinic-based pilot intervention to enhance diabetes management for elderly Hispanic patients. [2020]

6. England pubmed.ncbi.nlm.nih.gov

What happens between visits? Adverse and potential adverse events among a low-income, urban, ambulatory population with diabetes. [2021]

7. Spain pubmed.ncbi.nlm.nih.gov

[What do diabetic patients and what should they do to avoid errors in the course of treatment?]. [2015]

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

Safety during the monitoring of diabetic patients: trial teaching course on health professionals and diabetics - SEGUDIAB study. [2021]

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

Insulin, hospitals and harm: a review of patient safety incidents reported to the National Patient Safety Agency. [2021]

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

Unintentional therapeutic errors involving insulin in the ambulatory setting reported to poison centers. [2011]

11. Ireland pubmed.ncbi.nlm.nih.gov

Self-management programs conducted within a practice setting: who participates, who benefits and what can be learned? [2022]

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

Sustaining self-management in diabetes mellitus. [2019]

13. Canada pubmed.ncbi.nlm.nih.gov

Evaluating the Impact of Diabetes Self-Management Education Methods on Knowledge, Attitudes and Behaviours of Adult Patients With Type 2 Diabetes Mellitus. [2022]

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

An experiential model of learning diabetes self-management. [2017]

15. England pubmed.ncbi.nlm.nih.gov

Effectiveness of individual strategies for the empowerment of patients with diabetes mellitus: A systematic review with meta-analysis. [2022]