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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Behavioral: High Frequency Financial Incentive
* Behavioral: Moderate Frequency Financial Incentive
* Behavioral: Low Frequency Financial Incentive


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Frequency Financial Incentive<br>This arm will receive telephone delivered diabetes education and skills training in combination with the high frequency incentive structure | Behavioral: High Frequency Financial Incentive<br>* Diabetes Education/Skills Component. Subjects will receive weekly telephone-delivered diabetes/skills training for 12 weeks with home telemonitoring. High Frequency Financial Incentive: the high frequency incentive structure will receive a reward for uploading glucose measurements, attending educational sessions, and absolute percentage drops in HbA1c from baseline at 3-month follow-up, up to $300. Each week participants can receive up to $10 for uploading glucose measurements and having good glucose control throughout the week. If they upload measurements every day of the week and their average glucose measurements at the end of the week are 150 or below they will receive an additional $3. Participants can also earn $5 each week if they attend the educational session. After 3 months, if their HbA1c has dropped 2% from baseline, or absolute HbA1c is 7%, they will receive a reward of $130, for a 1% drop, or an absolute HbA1c between 7 and 8 they will receive a reward of $65.<br>* Other names: Group 3;|
| Experimental: Moderate Frequency Financial Incentive<br>This arm will receive telephone delivered diabetes education and skills training in combination with the moderate frequency incentive structure | Behavioral: Moderate Frequency Financial Incentive<br>* Diabetes Education/Skills Component. Subjects will receive weekly telephone-delivered diabetes/skills training for 12 weeks with home telemonitoring. Moderate Frequency Financial: the moderate frequency incentive structure will receive a reward for uploading glucose measurements, and absolute percentage drops in HbA1c from baseline at 3-month follow-up, up to $300. Each week participants can receive up to $10 for uploading glucose measurements and having good glucose control throughout the week. For each day they upload at least one glucose measurement, they will receive $1 (up to $7 at the end of the week). If they upload measurements every day of the week and their average glucose measurements at the end of the week are 150 or below they will receive an additional $3. After 3 months, if their HbA1c has dropped 2% from baseline, or absolute HbA1c is 7%, they will receive a reward of $170, for a 1% drop, or an absolute HbA1c between 7 and 8 they will receive a reward of $85<br>* Other names: Group 2;|
| Experimental: Low Frequency Financial Incentive<br>This arm will receive telephone delivered diabetes education and skills training in combination with the low frequency incentive structure | Behavioral: Low Frequency Financial Incentive<br>* Diabetes Education/Skills Component. Subjects will receive weekly telephone-delivered diabetes/skills training for 12 weeks with home telemonitoring. Low Frequency Financial Incentive: the low frequency incentive structure will receive a reward for absolute percentage drops in HbA1c from baseline at 3-month follow-up, up to $300. After 3 months, if their HbA1c has dropped 2% from baseline, or absolute HbA1c is 7%, they will receive a reward of $300, for a 1% drop, or an absolute HbA1c between 7 and 8 they will receive a reward of $150.<br>* Other names: Group 1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | 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. | Baseline to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resource Utilization and Cost | Resource Utilization & Cost: Information on hospitalizations, physician/professional visits, and medications will be captured. Time points used in calculation are baseline to 3 month. | Baseline to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blacks, Diabetes Mellitus, Type 2, Diabetes Mellitus, Adult-Onset, Diabetes Mellitus, Non-Insulin-Dependent, Diabetes Mellitus, Noninsulin Dependent, Diabetes Mellitus, Type II, African American, non-Hispanic Blacks, Randomized Control Trial, Controlled Clinical Trial, Behavioral Research, Behavioral Medicine