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

Not Applicable

Completed

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

Interventions: Behavioral: High Frequency Financial Incentive
Behavioral: Moderate Frequency Financial Incentive
Behavioral: Low Frequency Financial Incentive

Registration Number: NCT02722499

Lead Sponsor: State University of New York at Buffalo

Brief Summary: 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).

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Frequency Financial Incentive	High Frequency Financial Incentive	This arm will receive telephone delivered diabetes education and skills training in combination with the high frequency incentive structure
Moderate Frequency Financial Incentive	Moderate Frequency Financial Incentive	This arm will receive telephone delivered diabetes education and skills training in combination with the moderate frequency incentive structure
Low Frequency Financial Incentive	Low Frequency Financial Incentive	This arm will receive telephone delivered diabetes education and skills training in combination with the low frequency incentive structure

Primary Outcome Measures

Name	Time	Method
HbA1c	Baseline to 3 months	Hemoglobin A1c (HbA1c): blood specimens will be collected at the screening visit, as well as the 3-months. Time points used in calculation are baseline to 3 month.

Secondary Outcome Measures

Name	Time	Method
Resource Utilization and Cost	Baseline to 3 months	Resource Utilization \& Cost: Information on hospitalizations, physician/professional visits, and medications will be captured. Time points used in calculation are baseline to 3 month.