Financial Incentives And Nurse Coaching to Enhance Diabetes Outcomes (FINANCE-DM)-1

Summary

Participation Requirements

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 te...

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 The study also will evaluate whether intervention effects are sustained 6 months after the financial incentives are withdrawn (i.e. 18 months post randomization); and whether the intervention is differentially efficacious across racial/ethnic groups.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. Patient Randomization. A permuted block randomization method will be used to assign subjects to one of the two intervention groups: (a) FITNESS intervention; and (b) Active Comparator. This method will ensure a balance between treatment arms in the temporal recruitment sequence. Block size will be varied to prevent selection bias and to protect blinding. The randomization will be carried out separately for each racial/ethnic group, and additionally stratified by clinical site (MCW, VA and Community), baseline HbA1c levels (8-10% vs. >10%) and income level (<$50,000 vs $50,000+). Using REDCap, RAs will collect eligibility information and enter the information into the study database via the secured study website. Once eligibility is confirmed, intervention assignment will be made by a pre-programmed randomization scheme. All subjects who are randomized will be entered into the study database and analyzed according to CONSORT guidelines. Description of the FINANCE-DM Intervention. The FINANCE-DM intervention is comprised of: 1) nurse education, 2) home telemonitoring, and 3) structured financial incentives (see appendix for manual). Nurse delivered diabetes education and skills training: Trained nurses educators will deliver the manualized diabetes education and skills training intervention via telephone. Subjects will receive 8 weekly sessions of diabetes education and skills training and monthly booster sessions from months 3-12. Each session will last for ~30 minutes and comprise of 15 minutes of a previously tested diabetes education intervention based on ADA guidelines and 15 minutes of diabetes-tailored skills training intervention using motivational enhancement approaches. The skills training sessions will stress individualized problem-solving and self-monitoring strategies in adopting lifestyle modifications and will be focused on 4 behaviors-physical activity, diet, medication adherence, and glucose self-monitoring. FORA 2-in-1 home telemonitoring system: To support behavioral skills training, patients will be assigned the FORA 2-in-1 Telehealth System and provided glucose test strips to allow testing at least once a day. The device automatically uploads readings to a secure server as they are performed. The nurse educators will have access to the secure server to which the uploaded measurements are stored in real time. The glucose and BP readings will be used to tailor and reinforce behavior change during weekly telephone-delivered diabetes education and skills training sessions and subsequent booster sessions. Training on Device Use and Run-in Period Participants will receive detailed training on the use of the FORA system and how to problem solve around common issues with home monitoring devices by the study nurse educators. Investigators have identified common issues that patients experience with set up and ongoing use of the system from our prior studies and will incorporate that into the training process for participants. In addition, participants will have a two week run-in period to familiarize themselves with the FORA system and work with study nurse educators to address connectivity issues and other concerns that may arise. After the initial two week run-in period, participants will continue to have access to the nurses to address technology-related issues that arise. High Frequency Financial Incentive: In addition to nurse delivered diabetes education and skills training, participants will receive high frequency financial incentives based on the structure tested in our pilot RCT. Incentive Structure: Participants will receive a reward 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 as follows: Each week participants can receive up to $10 for uploading glucose measurements and having good glucose control throughout the week. For each day participants upload at least one glucose measurement, participants will receive $1 (up to $7 at the end of the week). If participants upload measurements every day of the week and the participants average glucose measurements at the end of the week are 150 or below participants will receive an additional $3. Up to $10 per week for each 3-month period. Participants can also earn $5 each week if participating in the telephone delivered educational session. Educational sessions will last for 8 weeks, so participants can receive up to $5 per week for 8 weeks. Participants can also earn $5 for attending monthly booster sessions from months 3-12. After each 3-month interval, if their HbA1c has dropped 2% from baseline, or absolute HbA1c is <7%, participants will receive a reward of $130; for a 1% drop, or an absolute HbA1c between 7 and 8 participants will receive a reward of $65. Therefore, over the 12 months duration of the intervention each subject can receive a maximum of $520 for uploading daily glucose readings, $85 for participating in telephone delivered educational sessions, and $520 for 2% absolute drop in HbA1c or maintaining HbA1c below 7%, for a maximum incentive of $1,125. Active Comparator Group (TIDES Intervention). 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. In essence, 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 (see appendix for manual). The only difference is that participants will not receive structured financial incentives. Contents of Individual Treatment Sessions. After enrollment, randomization, and baseline assessment, each subject will come in for a face-to-face meeting with the nurse diabetes educators. The primary purpose of the face-to-face visit is for the nurse educators to establish rapport, go over the study in detail, obtain patient contact information, primary and alternate telephone numbers, and establish guidelines for follow-up calls. In addition, subjects will receive information specific to their group.

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