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HSRProj (Health Services Research Projects in Progress)

Information about ongoing health services research and public health projects

Patient- and caregiver-centered diabetes telemanagement program for Hispanic/Latino patients
Investigator (PI): Pekmezaris, Renee
Performing Organization (PO): (Current): Northwell Health, Feinstein Institutes for Medical Research / (516) 562-3467
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2018
Final Year: 2023
Record Source/Award ID: PCORI/AD-2017C3-9185
Funding: Total Award Amount: $2,973,996
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: This research project is in progress. PCORI will post the research findings on the PCORI website within 90 days after the results are final. What is the research about? Type 2 diabetes is a long-term illness that causes blood sugar levels to rise. Diabetes causes many health problems and can be hard to manage. More than half of Hispanics in the United States will develop type 2 diabetes in their lifetime. Usual care for diabetes includes doctor visits, monitoring of blood glucose, screening for other health problems, and medicine. Patients may also have access to a diabetes educator. In this study, the research team is comparing two ways to help Hispanic patients with diabetes manage their illness. One way is usual diabetes care provided during doctor office visits plus diabetes telemanagement, or DTM. DTM allows patients to track vital signs, such as pulse and blood pressure, and communicate with their clinician, such as a doctor or nurse practitioner, through their smart phone, tablet, or other smart device. The other way is usual diabetes care alone. Who can this research help? Results may help doctors when considering ways to help Hispanic patients manage type 2 diabetes. What is the research team doing? This study has two parts. In the first part, the research team is working with patients, caregivers, community leaders, and the American Diabetes Association to adapt a DTM program for Hispanic patients. In the second part, the research team is enrolling 240 Hispanic patients with type 2 diabetes from the New York City area. The team is assigning patients by chance to take part in the adapted DTM program in addition to their usual diabetes care or receive usual care alone. Doctors teach patients how to check their blood sugar. Patients have routine visits every three months and can consult a diabetes educator. Patients in the DTM program and their caregivers receive tablets that connect them to a clinician. The DTM program also includes (1) weekly real-time virtual visits between the patient and a certified diabetes care and education nurse, (2) vital signs monitoring, (3) blood sugar monitoring, (4) reminders to take medicines, (5) educational videos and quizzes for patients on ways to manage diabetes, and (6) an app caregivers can use to interact with and remind the patient to follow his or her care plan. Over a period of six months, a nurse from the research team follows up with patients to ask about (1) health care use, (2) diabetes symptoms, (3) confidence in diabetes self-care, (4) quality of life, (5) distress related to diabetes, and (6) sick days from work. The research team is looking at patients' medical records to collect data on weight, cholesterol, blood pressure, and diabetes control. Hispanic people with diabetes are helping to plan and conduct the study. Research methods. Design: The study design is a randomized controlled trial. Population: The study population is 240 Hispanic adults diagnosed with type 2 diabetes. Interventions/comparators are usual diabetes care plus DTM and usual diabetes care alone. Outcomes: Outcomes are (a) primary: HbA1c at 6 months; and (b) secondary: HbA1c at 12 months, hypoglycemic episodes, adherence, diabetes self-efficacy, problem areas in diabetes, weight, cholesterol, blood pressure, diabetes quality of life, diabetes distress, inpatient utilization, and unscheduled type 2 diabetes physician visits. The timeframe is 6-month follow-up for primary outcome.
Abstract Archived: Over half of Hispanics/Latinos will develop type 2 diabetes in their lifetime. This increases the risk of death and other health issues such as amputation by 50-100% more than for non-Hispanic white patients with type 2 diabetes. Diabetes telemanagement programs (DTM) can now use technology to connect patients with their care provider for a weekly "tele-visit" and allow them to have their blood sugar and vital signs monitored daily. The purpose of this study is to see whether providing this kind of programming will improve care for patients with type 2 diabetes, compared to comprehensive outpatient management, the most common treatment approach for Hispanic patients from lower income and health access communities. There are two parts to this study. The first part uses qualitative methods to "adapt" the DTM program intervention for Hispanic/Latino disparity patients, using a community advisory board comprised of patients, caregivers, community leaders, and other important stakeholders such as community-based organizations (Vida Si, Diabetes No) and the American Diabetes Association. The second part tests this "adapted" program scientifically using what is called a randomized controlled trial, to see if it is more effective than comprehensive outpatient management. Patients who receive comprehensive outpatient management receive clinic care to manage their type 2 diabetes, while the patients who receive DTM (and their caregivers--such as their children) will be given tablets (like an iPad) that easily connects them to the nurse practitioner. The caregiver part of the program was suggested by our community advisory board, as well as by interviews with patients. The idea is that patients who are more engaged in their care through DTM will experience less illness, less hospitalization, have a better quality of life, and be more self-confident in their ability to manage their diabetes. We also want to see if involving caregivers improves the care and quality of life of patients. While this kind of intervention has been studied in the general population, and has found that sugar management improves, no one has studied whether this will be better for Hispanic disparity patients with type 2 diabetes--so this will be the first study of its kind. This study is an important one, because our patients tell us (and other studies have shown) that the outcomes we are focusing on are important to them. We are looking at quality of life, confidence in managing diabetes, hospitalizations, use of emergency department services, and worry ("distress") about their diabetes. Patients and other stakeholders are very involved in this project--both as part of the research team and as members of the community advisory board, which guides the research team through all aspects of the study. We also involve patients in "theater testing"--where we "test" the intervention with patients.

MeSH Terms:
  • Access to Health Care
  • Caregivers /*psychology
  • Community Health Services
  • Cultural Characteristics
  • Diabetes Mellitus, Type 2 /*ethnology
  • /*psychology
  • Health Care Disparities
  • Hispanic Americans
  • Humans
  • Outcome Assessment, Health Care
  • Patient-Centered Care /*methods
  • Psychological Stress /*complications
  • /*ethnology
  • Quality of Life
  • Randomized Controlled Trials as Topic
  • Telemedicine /*methods
  • United States
Country: United States
State: New York
Zip Code: 11030
UI: 20192190
CTgovId: NCT03960424
Project Status: Ongoing
Record History: ('2020: Archived abstract to Abstract Archived 1 field and added new abstract. Alternate Title: Comparing two ways to help Hispanic patients manage type 2 diabetes',)