Diabetes MellitusFITESTNCT02722499
Financial Incentives Telephone Education and Skills Trial in African Americans With Diabetes (FITEST)
A study testing High Frequency Financial Incentive, Moderate Frequency Financial Incentive and Low Frequency Financial Incentive in people with Diabetes Mellitus and Type 2 Diabetes Mellitus, run by State University of New York at Buffalo at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 21 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2 Diabetes Mellitus, Adult-Onset Diabetes Mellitus
- What is being tested?
- High Frequency Financial Incentive, Moderate Frequency Financial Incentive and Low Frequency Financial Incentive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Financial Incentives Augmented Telephone Education and Skills Trial in African Americans With Diabetes (FITEST)
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).
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2 Diabetes Mellitus, Adult-Onset Diabetes Mellitus, Non-Insulin-Dependent Diabetes Mellitus, Noninsulin Dependent Diabetes Mellitus, Type II
- Being tested
- High Frequency Financial Incentive, Moderate Frequency Financial Incentive, Low Frequency Financial Incentive
- 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
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Frequency Financial IncentiveBehavioural
Also called Group 3
- 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 IncentiveBehavioural
Also called Group 2
- 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 IncentiveBehavioural
Also called Group 1
- 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.
| Study group | Role | What they receive |
|---|---|---|
| High Frequency Financial Incentive | Experimental | This arm will receive telephone delivered diabetes education and skills training in combination with the high frequency incentive structure Receives: Behavioral: High Frequency Financial Incentive |
| Moderate Frequency Financial Incentive | Experimental | This arm will receive telephone delivered diabetes education and skills training in combination with the moderate frequency incentive structure Receives: Behavioral: Moderate Frequency Financial Incentive |
| Low Frequency Financial Incentive | Experimental | This arm will receive telephone delivered diabetes education and skills training in combination with the low frequency incentive structure Receives: Behavioral: Low Frequency Financial Incentive |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 3 months
Secondary outcomes (1)
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.
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2021
- Study completionMar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of South Carolina
- Responsible party
- Principal investigator, Leonard Ehianu Egede, State University of New York at Buffalo
- Investigators
- Leonard E Egede, MD, MS, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02722499
- Sponsor's protocol ID
- Pro00021791
- Acronym
- FITEST
- Status last verified
- Jul 2024
- First submitted
- 23 Mar 2016
- Last updated
- 12 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 33435969Egede 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.
PubMed 33735275
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Financial Incentives Augmented Telephone Education and Skills Trial in African Americans With Diabetes (FITEST)
- ClinicalTrials.gov ID
- NCT02722499
- Acronym / sponsor ID
- FITEST / Pro00021791
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- Medical University of South Carolina
- Study start
- Mar 2016 (actual)
- Primary completion
- Mar 2021 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 30 Mar 2016 (estimated)
- Results
- Posted 5 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Frequency Financial Incentive | Experimental | Behavioral: High Frequency Financial IncentiveThis arm will receive telephone delivered diabetes education and skills training in combination with the high frequency incentive structure |
| Moderate Frequency Financial Incentive | Experimental | Behavioral: Moderate Frequency Financial IncentiveThis arm will receive telephone delivered diabetes education and skills training in combination with the moderate frequency incentive structure |
| Low Frequency Financial Incentive | Experimental | Behavioral: Low Frequency Financial IncentiveThis arm will receive telephone delivered diabetes education and skills training in combination with the low frequency incentive structure |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Frequency Financial IncentiveAlso: Group 31. Diabetes Education/Skills Component. Subjects will receive weekly telephone-delivered diabetes/skills training for 12 weeks with home telemonitoring. 2. 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. | Behavioural | High Frequency Financial Incentive |
| Moderate Frequency Financial IncentiveAlso: Group 21. Diabetes Education/Skills Component. Subjects will receive weekly telephone-delivered diabetes/skills training for 12 weeks with home telemonitoring. 2. 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 | Behavioural | Moderate Frequency Financial Incentive |
| Low Frequency Financial IncentiveAlso: Group 11. Diabetes Education/Skills Component. Subjects will receive weekly telephone-delivered diabetes/skills training for 12 weeks with home telemonitoring. 2. 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. | Behavioural | Low Frequency Financial Incentive |
Primary outcome
HbA1c
Time frame: Baseline to 3 months
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.
1 secondary outcome
Resource Utilization and Cost
Time frame: Baseline to 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33435969Egede 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.
- Results publication: PubMed 33735275Egede 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.
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonard E Egede, MD, MS principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Frequency Financial Incentive, Moderate Frequency Financial Incentive and Low Frequency Financial Incentive in people with Diabetes Mellitus and Type 2 Diabetes Mellitus, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: Baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02722499, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.