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

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ClinicalTrials.gov Identifier: NCT04203173
Recruitment Status : Recruiting
First Posted : December 18, 2019
Last Update Posted : February 8, 2022
Sponsor:
Information provided by (Responsible Party):
Egede, Leonard E, Medical College of Wisconsin

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control long term? 2) Are the effects of financial incentives on metabolic control sustained once the incentives are withdrawn?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 The study also will evaluate whether intervention effects are sustained 6 months after the financial incentives are withdrawn (i.e. 18 months post randomization); and whether the intervention is differentially efficacious across racial/ethnic groups.

Primary Aim 1: To test the efficacy of the FINANCE-DM Intervention on glycemic control at 12 months (long-term effect) and 18 months (sustainability effect) for Adults with poorly controlled T2DM (overall efficacy across combined racial/ethnic groups).

Hypothesis 1: Patients randomized to FINANCE-DM intervention will have significantly greater improvements in glycemic control (HbA1c) at 12 months (long-term effect) and 18 months (sustainability effect) of follow-up compared to the active control group.

Primary Aim 2: To test whether the effect of FINANCE-DM on glycemic control at 12 and 18 months is consistent across three racial/ethnic groups (Whites, AAs, HAs) and, if differential effect of the intervention is found, to estimate magnitude and direction of effect for the three racial/ethnic groups (efficacy within racial/ethnic groups).

Hypothesis 2: While all racial/ethnic groups (Whites, AAs, HAs) will have greater improvements in glycemic control (HbA1c) at 12 months (long-term effect) and 18 months (sustainability effect) of follow-up compared to the active control group, the effect on the FINANCE-DM intervention will be significantly greater among ethnic minority patients (AAs and HAs) compared to Whites.

Primary Aim 3: To determine the cost-effectiveness of the FINANCE-DM intervention.

Hypothesis 3. The FINANCE-DM intervention will be more cost-effective in improving glycemic control (HbA1c) at 12 months (long-term effect) and 18 months (sustainability effect), compared to an active control group, as measured by differences in program costs and resource utilization.

Secondary Aim: To test the efficacy of the FINANCE-DM intervention on secondary endpoints including BP, LDL, QOL and self-care behaviors (diet, exercise and medication adherence) at 12 and 18 months.

Hypothesis 4: Patients randomized to the FINANCE-DM intervention will have significantly greater improvements in BP, LDL, QOL and self-care behaviors at 12 months (long-term effect) and 18 months (sustainability effect) of follow-up compared to an active control group.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: FINANCE-DM Behavioral: Active Comparator Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Financial Incentives And Nurse Coaching to Enhance Diabetes Outcomes - FINANCE-DM
Actual Study Start Date : December 1, 2019
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FINANCE-DM Intervention
The FINANCE-DM intervention is comprised of: 1) nurse education, 2) home telemonitoring, and 3) structured financial incentives.
Behavioral: FINANCE-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.

Active Comparator: TIDES Intervention
Patients randomized to the active comparator group will be assigned the FORA 2-in-1 Telehealth System. A nurse educator will review the glucose and BP readings and use them to tailor and reinforce behavior change.
Behavioral: Active 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.




Primary Outcome Measures :
  1. Glycemic control (HbA1c) [ Time Frame: Change from baseline HbA1c at 12 months post intervention follow-ups ]
    Blood specimens (10cc of blood) will be obtained by trained phlebotomists or nurse for HbA1c.

  2. Resource Utilization and Cost [ Time Frame: Change from baseline resource utilization and cost at at 12 months post-intervention follow-ups ]
    Previously validated questions on resource utilization will be administered. The questionnaires capture information on hospitalizations, physician/professional visits, and medications.


Secondary Outcome Measures :
  1. LDL-Cholesterol [ Time Frame: Change from baseline cholesterol at at 12 months post intervention follow-ups ]
    About 10cc of blood will be drawn by trained phlebotomists and sent to the lab for LDL-Cholesterol.

  2. Quality of Life as measured by SF-12 [ Time Frame: Change from baseline quality of life measure at at 12 months post intervention follow-ups ]
    The SF-12 (Ware 1996) is a valid and reliable instrument to measure functional status and reproduces 90% of the variance in PCS-36 and MCS-36 scores.

  3. Systolic and Diastolic Blood Pressure [ Time Frame: Change from baseline blood pressure at at 12 months post intervention follow-ups ]
    Blood pressure readings will be obtained using automated BP monitors (OMRON IntelliSenseTM HEM-907XL). The device will be programmed to take 3 readings at 2-minute intervals, and give an average of the 3 BP readings.

  4. Self-Care Behavior [ Time Frame: Change from baseline self-care at at 12 months post intervention follow-ups ]
    Behavioral skills will be assessed with the Summary of Diabetes Self-Care Activities (SDSCA) scale (Toobert 2000), a brief, validated questionnaire of diabetes self-care. .

  5. Self-Care Behavior Brooks Medication Adherence Scale (BMAS) [ Time Frame: Change from baseline self-care at at 12 months post intervention follow-ups ]
    Medication Adherence will be measured with the 6-item validated self-report Brooks Medication Adherence Scale (BMAS) (Brooks 1994). Each of 6 items measures a specific medication-taking behavior.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT04203173


Contacts
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Contact: Elise A Mosley-Johnson, MPH 414-955-8810 emosley@mcw.edu

Locations
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United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Elise Mosley-Johnson, MPH    414-955-8810    emosley@mcw.edu   
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
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Principal Investigator: Leonard E Egede, MD, MS Medical College of Wisconsin
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Egede, Leonard E, Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT04203173    
Other Study ID Numbers: 1R01DK120861 ( U.S. NIH Grant/Contract )
First Posted: December 18, 2019    Key Record Dates
Last Update Posted: February 8, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases