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

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ClinicalTrials.gov Identifier: NCT02722499
Recruitment Status : Active, not recruiting
First Posted : March 30, 2016
Last Update Posted : July 19, 2019
Sponsor:
Collaborator:
Medical University of South Carolina
Information provided by (Responsible Party):
Egede, Leonard E, Medical College of Wisconsin

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).

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Diabetes Mellitus Adult-Onset Diabetes Mellitus Non-Insulin-Dependent Diabetes Mellitus Noninsulin Dependent Diabetes Mellitus, Type II Behavioral: Financial Incentive Augmented Education and Skills Training Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Financial Incentives Augmented Telephone Education and Skills Trial in African Americans With Diabetes (FITEST)
Study Start Date : March 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High Frequency Financial Incentive

The high frequency incentive structure will receive a reward or 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.

Participants can also earn $5 each week if they attend the educational session. Educational sessions will last for 8 weeks, so they can receive up to $5 per week for 8 weeks.

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.

Behavioral: Financial Incentive Augmented Education and Skills Training
The intervention is based on the IMB model and provides information, motivation, and behavioral skills training (using motivational enhancement techniques). Subjects will receive weekly telephone-delivered diabetes knowledge/information, patient activation (list of 5 questions to ask their provider at every visit and training on how to ask the questions), patient empowerment (diabetes responsibility contracts, personal goals, and flow charts for patients to record lab results/medications and training on how to use the empowerment tools), and behavioral skills training delivered via telephone. The intervention will be delivered by telephone once a week for 12 weeks with each session lasting ~30 minutes

Experimental: Moderate Frequency Financial Incentive

Each week participants in Group B 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. Up to $10 per week for 3-months.

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

Behavioral: Financial Incentive Augmented Education and Skills Training
The intervention is based on the IMB model and provides information, motivation, and behavioral skills training (using motivational enhancement techniques). Subjects will receive weekly telephone-delivered diabetes knowledge/information, patient activation (list of 5 questions to ask their provider at every visit and training on how to ask the questions), patient empowerment (diabetes responsibility contracts, personal goals, and flow charts for patients to record lab results/medications and training on how to use the empowerment tools), and behavioral skills training delivered via telephone. The intervention will be delivered by telephone once a week for 12 weeks with each session lasting ~30 minutes

Experimental: Low Frequency Financial Incentive

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.

Thus, the maximum reward for each subject will be $300 over the 3 months of intervention and follow up.

Behavioral: Financial Incentive Augmented Education and Skills Training
The intervention is based on the IMB model and provides information, motivation, and behavioral skills training (using motivational enhancement techniques). Subjects will receive weekly telephone-delivered diabetes knowledge/information, patient activation (list of 5 questions to ask their provider at every visit and training on how to ask the questions), patient empowerment (diabetes responsibility contracts, personal goals, and flow charts for patients to record lab results/medications and training on how to use the empowerment tools), and behavioral skills training delivered via telephone. The intervention will be delivered by telephone once a week for 12 weeks with each session lasting ~30 minutes




Primary Outcome Measures :
  1. HbA1c [ Time Frame: 3 months post randomization ]
    Hemoglobin A1c (HbA1c): blood specimens will be collected at the screening visit, as well as the 3-months

  2. Blood Pressure [ Time Frame: 3 months post randomization ]
    Blood pressure measurement: Blood pressure readings will be obtained at baseline, 3-months

  3. Quality of Life (SF-12) [ Time Frame: 3 months post randomization ]
    Quality of Life: The Short Form-12 (SF-12) is a valid and reliable instrument to measure functional status. The SF-12 items reproduce at least 90% of the variance in physical component (PCS-36) and mental component (MCS-36) scores.

  4. Resource Utilization and Cost [ Time Frame: 3 months post randomization ]
    Resource Utilization & Cost: Information on hospitalizations, physician/professional visits, and medications will be captured



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02722499


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical College of Wisconsin
Medical University of South Carolina
Investigators
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Principal Investigator: Leonard E Egede, MD, MS Medical University of South Carolina

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Responsible Party: Egede, Leonard E, Chief, Division of General Internal Medicine, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT02722499     History of Changes
Other Study ID Numbers: Pro00021791
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019

Keywords provided by Egede, Leonard E, Medical College of Wisconsin:
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

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases