Type 2 Diabetes
Conditions
Brief summary
The objective of this protocol is to answer the questions: 1) Are financial incentives layered upon nurse education and home telemonitoring superior to nurse education and home telemonitoring alone in improving metabolic control long term? 2) Are the effects of financial incentives on metabolic control sustained once the incentives are withdrawn? and 3) Are financial incentives efficacious within and consistent across racial/ethnic groups? This study provides a unique opportunity to address these gaps in the literature. Investigators propose a randomized controlled trial to test the efficacy of a Financial Incentives And Nurse Coaching to Enhance Diabetes Outcomes (FINANCE-DM) intervention comprised of: 1) nurse education, 2) home telemonitoring, and 3) structured financial incentives; compared to an active control group (nurse education and home telemonitoring alone). The study also will evaluate whether intervention effects are sustained 6 months after the financial incentives are withdrawn (i.e. 18 months post randomization); and whether the intervention is differentially efficacious across racial/ethnic groups.
Detailed description
Study Overview. The overarching aim of this proposal is to test the efficacy of structured financial incentives intervention (FINANCE-DM) comprised of: 1) nurse education, 2) home telemonitoring, and 3) structured financial incentives; compared to an active control group (nurse education and home telemonitoring alone) on glycemic control. The study also will evaluate whether intervention effects are sustained 6 months after the financial incentives are withdrawn (i.e. 18 months post randomization); and whether the intervention is differentially efficacious across racial/ethnic groups. Equal number of patients from three racial/ethnic groups (150 Whites, 150 AAs and 150 HAs, total sample of 450) will be randomized to FINANCE-DM intervention (n=225) or an active comparator group (n=225), so that within each racial/ethnic group, half (75 patients) will be randomized to the FINANCE-DM intervention group and the other half (75 patients) will be randomized to the active comparator group. Primary aims are to test overall efficacy across combined racial/ethnic groups; efficacy within racial/ethnic groups and cost effectiveness for the primary endpoint (glycemic control). Secondary aim is to test efficacy on secondary endpoints including BP, LDL, QOL and self-care behaviors. Each patient will be followed for 12 months (long-term effect) and 18 months (sustainability effect), with study visits at baseline, 3, 6, 9, 12 and 18 months. The FINANCE-DM intervention is comprised of: 1) nurse education, 2) home telemonitoring, and 3) structured financial incentives. The active comparator group will receive the same nurse education and home telemonitoring intervention as the FINANCE-DM group, on the same schedule, and for the same duration . The only difference is that participants will not receive structured financial incentives.
Interventions
BEHAVIORALActive Comparator
Patients randomized to the active comparator group will be assigned the FORA 2-in-1 Telehealth System and provided glucose test strips to allow testing at least once a day. BG and BP will be measured daily and results will be uploaded to a secure server. A nurse educator will review the glucose and BP readings and use them to tailor and reinforce behavior change during weekly telephone-delivered diabetes education and skills training session.
BEHAVIORALFINANCE-DM
The FINANCE-DM intervention is comprised of: 1) nurse education, 2) home telemonitoring, and 3) structured financial incentives. Patients randomized to FINANCE-DM will be assigned the FORA 2-in-1 Telehealth System and provided glucose test strips to allow testing at least once a day. BG and BP will be measured daily and results will be uploaded to a secure server. A nurse educator will review the glucose and BP readings and use them to tailor and reinforce behavior change during weekly telephone-delivered diabetes education and skills training session. Participants will also receive financial rewards for: 1) uploading glucose measurements; 2) participating in telephone delivered educational sessions; and 3) absolute percentage drops in HbA1c from baseline at each 3-month follow-up intervals.
Sponsors
State University of New York at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \>=21 years; 2. Clinical diagnosis of T2DM and HbA1c \>=8% at the screening visit; 3. Self-identified as White, AA or HA; 4. Subject must be willing to use the FORA monitoring system for 12 months; 5. Subjects must have access to a landline, Ethernet or cellphone for FORA data uploads for the study period; and 6) Ability to communicate in English.
Exclusion criteria
1. Mental confusion on interview suggesting significant dementia; 2. Participation in other diabetes clinical trials; 3. Alcohol or drug abuse/dependency; 4. Active psychosis or acute mental disorder; and 5. Life expectancy \<18 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic Control (HbA1c) | HbA1c at 12 months follow-up | Blood specimens (10cc of blood) will be obtained by trained phlebotomists or nurse for HbA1c. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic Control (HbA1c) | HbA1c at 18 months follow-up | Blood specimens (10cc of blood) will be obtained by trained phlebotomists or nurse for HbA1c. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLeonard E Egede, MD, MS
State University of New York at Buffalo
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 57.7 years STANDARD_DEVIATION 29.3 |
| Race/Ethnicity, Customized Hispanic | 45 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 146 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 131 Participants |
| Region of Enrollment United States | 450 participants |
| Sex: Female, Male Female | 117 Participants |
| Sex: Female, Male Male | 219 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 224 | 0 / 226 |
| other Total, other adverse events | 0 / 224 | 0 / 226 |
| serious Total, serious adverse events | 0 / 224 | 0 / 226 |
Outcome results
None listed