Clinical trial NCT02722499: Financial Incentives Telephone Education and Skills Trial in African Americans With Diabetes (FITEST)
Official title: Financial Incentives Augmented Telephone Education and Skills Trial in African Americans With Diabetes (FITEST)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Type 2 Diabetes Mellitus
Adult-Onset Diabetes Mellitus
Non-Insulin-Dependent Diabetes Mellitus
Noninsulin Dependent Diabetes Mellitus, Type II
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
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: Medical University of South Carolina
First posted: 2016-03-30
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: HbA1c
timeFrame: Baseline to 3 months
Secondary outcomes:
measure: Resource Utilization and Cost
timeFrame: Baseline to 3 months
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Leonard E Egede, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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/s12913-020-06029-0.
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. doi: 10.1371/journal.pone.0248762. eCollection 2021.