Financial Incentives Telephone Education and Skills Trial in African Americans With Diabetes (FITEST)
Condition: Diabetes Mellitus; Type 2 Diabetes Mellitus; Adult-Onset Diabetes Mellitus; Non-Insulin-Dependent Diabetes Mellitus; Noninsulin Dependent Diabetes Mellitus, Type II
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

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.
    

Intervention name(s): High Frequency Financial Incentive; Moderate Frequency Financial Incentive; Low Frequency Financial Incentive
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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.; 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; 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.
Other intervention name(s): Group 3; Group 2; Group 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 2; Diabetes Mellitus, Adult-Onset; Diabetes Mellitus, Non-Insulin-Dependent; Diabetes Mellitus, Noninsulin Dependent; Diabetes Mellitus, Type II; African American; Blacks; non-Hispanic Blacks; Randomized Control Trial; Controlled Clinical Trial; Behavioral Research; Behavioral Medicine