Financial Incentives Telephone Education and Skills Trial in African Americans With Diabetes (FITEST)

University at Buffalo (UB)

Status: Completed

Conditions: Noninsulin Dependent Diabetes Mellitus, Type II; Type 2 Diabetes Mellitus; Diabetes Mellitus; Non-Insulin-Dependent Diabetes Mellitus; Adult-Onset Diabetes Mellitus

Treatments: Behavioral: High Frequency Financial Incentive; Behavioral: Low Frequency Financial Incentive; Behavioral: Moderate Frequency Financial Incentive

Study type: Interventional

Funder types: Other

Identifiers

NCT02722499

Pro00021791

Details and patient eligibility

About

The aim of this study is to test the efficacy of financial incentives augmented telephone-delivered diabetes education and skills training intervention in improving HbA1c levels in African Americans (AA) with type 2 diabetes (T2DM).

Full description

African Americans with T2DM have higher prevalence of diabetes, poorer metabolic control, and greater risk for complications and death compared to White Americans. HbA1c is the primary marker for glycemic control and is a strong independent predictor of development of complications and increased mortality in T2DM. Key self-care behaviors that influence glycemic control (and HbA1c) include diet, physical activity, self-monitoring of blood glucose and medication adherence. Systematic review of multiple RCTs show that self-care interventions that include diabetes education and skills training are effective in improving metabolic control in diabetes. Recent findings indicate that patients with diabetes, especially ethnic minority patients, prefer telephone-delivered diabetes education to group visits or internet-based education. Multiple RCTs have documented the effectiveness of telephone-delivered self-care interventions in T2DM.

The overarching aim of this proposal is test the efficacy of three financial incentive structures in combination with technology intensified diabetes education and skills training intervention on blood pressure and quality of life in AAs with T2DM. 60 AAs with T2DM will be randomized to three groups with varying frequency of financial incentives: 1) High Frequency: financial incentives for weekly uploads plus average glucose, incentives for weekly attendance to educational sessions, and incentives at the end of the study for meeting HbA1c goals 2) Moderate Frequency: financial incentives for weekly uploads plus average glucose, and incentives at the end of the study for meeting HbA1c goals, and 3) Low Frequency: financial incentives at the end of the study for meeting HbA1c goals.

Enrollment: 60 patients

Sex: All

Ages: 21 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age ≥21 years
• Clinical diagnosis of T2DM and HbA1c ≥8% at the screening visit
• Self-identified as AA
• Subject must be willing to use the FORA monitoring system for 3 months
• Subjects must be able to communicate in English
• Subjects must have access to a telephone (landline for data uploads) for the study period

Exclusion criteria

• Mental confusion on interview suggesting significant dementia
• Participation in other diabetes clinical trials
• Alcohol or drug abuse/dependency
• Active psychosis or acute mental disorder
• Life expectancy <12 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

High Frequency Financial Incentive

Experimental group

Description:

This arm will receive telephone delivered diabetes education and skills training in combination with the high frequency incentive structure

Treatment:

Behavioral: High Frequency Financial Incentive

Moderate Frequency Financial Incentive

Experimental group

Description:

This arm will receive telephone delivered diabetes education and skills training in combination with the moderate frequency incentive structure

Treatment:

Behavioral: Moderate Frequency Financial Incentive

Low Frequency Financial Incentive

Experimental group

Description:

This arm will receive telephone delivered diabetes education and skills training in combination with the low frequency incentive structure

Treatment:

Behavioral: Low Frequency Financial Incentive