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A patient-centered framework to test the comparative effectiveness of culturally and contextually appropriate program options for Latinos with diabetes from low-income households
Investigator (PI): Page-Reeves, Janet
Performing Organization (PO): (Current): University of New Mexico Health Sciences Center, Department of Family and Community Medicine / (505) 272-2165
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2016
Final Year: 2022
Record Source/Award ID: PCORI/CER-1511-32910 ; PCORI/AD-1511-32910
Funding: Total Award Amount: $2,276,443
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Background and significance: Diabetes is a national health problem, yet Latinos from low-income households are at greater risk. Although guidelines recommend that patients learn self-management strategies, many are not able to do so effectively and cannot control their diabetes. Studies show that culturally competent self-management programming can help, but patients told us that not all programs sufficiently respect patients' cultural values or account for their socioeconomic limitations. Study aims: This project will compare two models for culturally competent diabetes self-management programming. Our hypothesis is that the program model that best considers patient culture and accommodates patient socioeconomic circumstances will have the best outcomes. Study design: We have designed the research to follow PCORI's scientific requirements. We have completed calculations to make sure that enough people will participate so that our findings will be scientifically meaningful. We will gather data about patients at each of the programs. We made a detailed project timeline with specific accomplishments that include both scientific and engagement activities. We assembled a research team with the expertise and experience in patient-engaged research necessary for the proposed study, and we have support from both our university and our community partners. We also have included many opportunities for paid patient participation. Things we compare: We will compare two diabetes self-management program models used by many Latino patients from low-income households in Albuquerque, New Mexico: 1) the Diabetes Self-Management Support Empowerment Model and 2) the Chronic Care Model. Study population: Our patient advisors told us that gathering data from individuals alone does not account for important social aspects of Latino patients' lives, so we will recruit patients and ask them to invite someone close to them to participate too. Patients will be individuals who consider themselves to be Latino and who are from low-income households. We will recruit 240 patient-caregiver pairs through the two sites. Primary outcome: The primary outcome to be measured is improved capacity for diabetes self-management, measured as diabetes knowledge and patient activation or the ability to put that knowledge into action. Secondary outcome: The secondary outcome to be measured is successful diabetes self-management measured through reduced A1c, body mass index (BMI), and depression. We will also consider two exploratory clinical measures: 1) patient body composition; and 2) patient stress levels, measured using hair samples, to identify levels of cortisol as a biological marker for chronic stress. Methods: We will use statistical calculations to make sure that the things we are comparing are differences in program design and not differences in individual patient characteristics. We will compare whether the programs improve diabetes health knowledge, ability to act, A1c, BMI, body composition, and depression and stress control, and we will determine which program is best.
MeSH Terms:
  • Body Composition
  • Body Mass Index
  • Caregivers
  • Comparative Effectiveness Research
  • Cultural Characteristics
  • Depression /complications
  • Diabetes Mellitus, Type 2 /*ethnology
  • /*therapy
  • Guidelines as Topic
  • Hispanic Americans
  • Humans
  • New Mexico
  • Outcome Assessment, Health Care
  • Patient-Centered Care
  • Poverty
  • Self Care
  • Social Class
  • Stress, Psychological
  • United States
Country: United States
State: New Mexico
Zip Code: 87131
UI: 20164047
CTgovId: NCT03004664
Project Status: Ongoing
Record History: ('2020: New project ID added; Project extended to 2022. Project extended to 2021. 2017: Project extended to 2020.',)