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

Diabetes Mellitus Clinical Trial

— FITEST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02722499
• Other study ID #: Pro00021791
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: March 2021

Study information

• Verified date: October 2021
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• High Frequency Financial Incentive
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.
• Moderate Frequency Financial Incentive
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
• Low Frequency Financial Incentive
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.

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Medical University of South Carolina

Country where clinical trial is conducted

United States, 

References & Publications (2)

Egede LE, Campbell JA, Walker RJ, Dawson AZ, Williams JS. Financial incentives to improve glycemic control in African American adults with type 2 diabetes: a pilot randomized controlled trial. BMC Health Serv Res. 2021 Jan 13;21(1):57. doi: 10.1186/s12913 — View Citation

Egede LE, Walker RJ, Dismuke-Greer CE, Pyzyk S, Dawson AZ, Williams JS, Campbell JA. Cost-effectiveness of financial incentives to improve glycemic control in adults with diabetes: A pilot randomized controlled trial. PLoS One. 2021 Mar 18;16(3):e0248762. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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