100 Participants Needed

Diabetes Education and Support for Type 2 Diabetes

AZ
JA
Overseen ByJennifer A Campbell, PhD, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Medical College of Wisconsin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This study will test the preliminary efficacy of a nurse case-manager, telephone-delivered intervention that provides diabetes self-management education and skills training and resolves the unmet social needs of older African Americans with poorly controlled type 2 diabetes by randomizing 100 African Americans aged 50 years and older with poorly controlled type 2 diabetes to the Combined Diabetes Education/Skills Training and Social Needs Resolution (DM Social Needs) Intervention (n=50) and usual care (n=50) arms. The aims of this study are: Aim 1: Test the preliminary efficacy of the DM Social Needs intervention on clinical outcomes in older AAs with uncontrolled type 2 diabetes. Aim 2: Test the preliminary efficacy of the DM Social Needs intervention on patient reported outcomes in older AAs with uncontrolled type 2 diabetes.

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 is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment DM Social Needs, Combined Diabetes Education/Skills Training and Social Needs Resolution Intervention, DM Social Needs Intervention, Usual Care, Standard Care, Conventional Care for Type 2 Diabetes?

Research shows that combining diabetes education with social support can improve self-care and lifestyle behaviors in people with type 2 diabetes. Programs that include social learning and support, such as group consultations and peer support, have been found to enhance patient knowledge and psychosocial functioning, which are important for managing diabetes effectively.12345

Is the Diabetes Education and Support for Type 2 Diabetes treatment safe for humans?

The studies reviewed focus on diabetes education and social support interventions, which are generally safe as they involve education, social support, and resource navigation. No specific safety concerns were reported in these studies.15678

What makes the DM Social Needs treatment for Type 2 Diabetes unique?

The DM Social Needs treatment is unique because it combines diabetes education and skills training with addressing social needs, which can impact diabetes management. This approach includes navigation to resources and support from community health workers, aiming to improve self-management and address disparities in diabetes care.1591011

Research Team

AZ

Aprill Z Dawson, PhD, MPH

Principal Investigator

Medical College of Wisconsin

Eligibility Criteria

This trial is for African Americans aged 50 or older with poorly controlled type 2 diabetes (HbA1C levels of at least 8%). Participants must self-identify as Black and have a diagnosis of T2DM. Those with significant dementia, involvement in other diabetes trials, substance abuse issues, or a life expectancy less than six months cannot join.

Inclusion Criteria

Self-identified as African American or Black
I have been diagnosed with type 2 diabetes.
I am 50 years old or older.
See 1 more

Exclusion Criteria

You are currently taking part in another diabetes research study.
You have a history of alcohol or drug abuse or dependency as assessed by the CAGE-AID questionnaire.
You are not expected to live for more than 6 months from the time of screening.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the DM Social Needs intervention, including diabetes education and skills training, and resolution of social needs via telephone

6 months
6 monthly sessions (telephone)

Follow-up

Participants are monitored for changes in glycemic control and other outcomes after the intervention

6 months

Treatment Details

Interventions

  • DM Social Needs
  • Usual Care
Trial Overview The study compares the effectiveness of two approaches: a nurse-led intervention providing education and skills training along with addressing social needs (DM Social Needs), versus usual care. It involves randomly placing participants into one of these two groups to see which method better improves clinical and patient-reported outcomes.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: DM Social Needs InterventionExperimental Treatment1 Intervention
A trained health educator will deliver the manualized DM Social Needs intervention. Participants will receive 6-monthly sessions of diabetes education and skills training, and problem solving and resolution of social needs via telephone.
Group II: Usual CareActive Control1 Intervention
Participants in the usual care arm will receive mailed diabetes education materials in accordance with recommendations from the American Diabetes Association (ADA) monthly

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials
645
Recruited
1,180,000+

Findings from Research

In a study involving 78 type II diabetic outpatients, both nutrition education programs led to significant improvements in dietary goals compared to a control group, indicating their effectiveness in managing diabetes through dietary changes.
However, the addition of a social learning component did not provide any additional benefits over the standard nutrition education program, and there were minimal differences in long-term outcomes like weight or blood sugar levels.
Nutrition education and social learning interventions for type II diabetes.Glasgow, RE., Toobert, DJ., Mitchell, DL., et al.[2019]
The diabetes self-management program, which included six weekly sessions focusing on self-efficacy and a participatory approach, significantly improved HbA1c levels in participants, with normal levels increasing from 4.5% to 28.6% over 28 weeks (p<0.001).
Participants in the experimental group also showed significant improvements in self-efficacy, body mass index (BMI), and dietary behaviors compared to the control group, indicating that integrating social work with general practice can enhance diabetes management outcomes.
General practice and social service partnership for better clinical outcomes, patient self efficacy and lifestyle behaviours of diabetic care: randomised control trial of a chronic care model.Lee, A., Siu, CF., Leung, KT., et al.[2011]
A systematic review of six controlled trials found that specific social support interventions, like group consultations and Internet-based peer support, can positively impact health outcomes for people with type 2 diabetes, improving measures like HbA1c and physical activity.
Traditional forms of social support, such as from family and friends, did not show significant improvements in diabetes control, suggesting that innovative support methods may be more effective in helping patients manage their condition.
Social support in diabetes: a systematic review of controlled intervention studies.van Dam, HA., van der Horst, FG., Knoops, L., et al.[2022]

References

Nutrition education and social learning interventions for type II diabetes. [2019]
General practice and social service partnership for better clinical outcomes, patient self efficacy and lifestyle behaviours of diabetic care: randomised control trial of a chronic care model. [2011]
Social support in diabetes: a systematic review of controlled intervention studies. [2022]
Social Support of Patients with Type 2 Diabetes in Marginalized Contexts in Mexico and Its Relation to Compliance with Treatment: A Sociocultural Approach. [2020]
Bridge to Health/Puente a la Salud: a pilot randomized trial to address diabetes self-management and social needs among high-risk patients. [2023]
Learning types and learning success in a structured diabetes education programme for patients with type 2 diabetes: study protocol of a prospective, longitudinal study. [2020]
Relationship between a comprehensive social determinants of health screening and type 2 diabetes mellitus. [2021]
Integrating family and friend support, information technology, and diabetes education in community-centric diabetes self-management. [2021]
Effectiveness of group-based self-management education for individuals with Type 2 diabetes: a systematic review with meta-analyses and meta-regression. [2022]
Diabetes structured self-management education programmes: a narrative review and current innovations. [2018]
Type 2 diabetes peer support interventions as a complement to primary care settings in high-income nations: A scoping review. [2022]
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