Adult-Onset Diabetes Mellitus, Diabetes Mellitus, Non-Insulin-Dependent Diabetes Mellitus, Noninsulin Dependent Diabetes Mellitus, Type II, Type 2 Diabetes Mellitus
Conditions
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
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.
Interventions
BEHAVIORALHigh Frequency Financial Incentive
1. 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.
BEHAVIORALModerate Frequency Financial Incentive
1. 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
BEHAVIORALLow Frequency Financial Incentive
1. 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.
Sponsors
Medical University of South Carolina
State University of New York at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 100 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resource Utilization and Cost | Baseline to 3 months | Resource Utilization & Cost: Information on hospitalizations, physician/professional visits, and medications will be captured. Time points used in calculation are baseline to 3 month. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| High Frequency Financial Incentive This arm will receive telephone delivered diabetes education and skills training in combination with the high frequency incentive structure
High Frequency Financial Incentive: 1. 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. | 20 |
| Moderate Frequency Financial Incentive This arm will receive telephone delivered diabetes education and skills training in combination with the moderate frequency incentive structure
Moderate Frequency Financial Incentive: 1. 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 | 20 |
| Low Frequency Financial Incentive This arm will receive telephone delivered diabetes education and skills training in combination with the low frequency incentive structure
Low Frequency Financial Incentive: 1. 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. | 20 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 | 1 |
Baseline characteristics
| Characteristic | High Frequency Financial Incentive | Moderate Frequency Financial Incentive | Low Frequency Financial Incentive | Total |
|---|---|---|---|---|
| Age, Continuous | 58.2 years STANDARD_DEVIATION 9.6 | 57.4 years STANDARD_DEVIATION 8.8 | 58.1 years STANDARD_DEVIATION 14.1 | 57.4 years STANDARD_DEVIATION 11.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 20 Participants | 20 Participants | 60 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Hemoglobin A1c | 10.4 percentage of glycosylated hemoglobin STANDARD_DEVIATION 2.3 | 9.9 percentage of glycosylated hemoglobin STANDARD_DEVIATION 1.3 | 10.1 percentage of glycosylated hemoglobin STANDARD_DEVIATION 2.1 | 10.1 percentage of glycosylated hemoglobin STANDARD_DEVIATION 1.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants | 20 Participants | 20 Participants | 60 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 20 participants | 20 participants | 20 participants | 60 participants |
| Sex: Female, Male Female | 12 Participants | 12 Participants | 15 Participants | 39 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 5 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
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.
Time frame: Baseline to 3 months
Population: 20 subjects randomized to each arm, but 18 included in final analysis in high frequency, 20 in moderate frequency and 19 in low frequency arms respectively
| Arm | Measure | Value (MEAN) |
|---|---|---|
| High Frequency Financial Incentive | HbA1c | -1.73 mean change from baseline |
| Moderate Frequency Financial Incentive | HbA1c | -1.73 mean change from baseline |
| Low Frequency Financial Incentive | HbA1c | -1.25 mean change from baseline |
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.
Time frame: Baseline to 3 months
Population: 20 subjects randomized to each arm, but 18 included in final analysis in high frequency, 20 in moderate frequency and 19 in low frequency arms respectively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Frequency Financial Incentive | Resource Utilization and Cost | 3315.45 US Dollars | Standard Deviation 2014.43 |
| Moderate Frequency Financial Incentive | Resource Utilization and Cost | 4649.68 US Dollars | Standard Deviation 5393.52 |
| Low Frequency Financial Incentive | Resource Utilization and Cost | 3765.57 US Dollars | Standard Deviation 2765.57 |