Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT02339311 |
| Other study ID # |
10-249 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 2012 |
| Est. completion date |
December 2012 |
Study information
| Verified date |
January 2024 |
| Source |
University of New Mexico |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
One in three people will be diagnosed with diabetes by 2050, and the proportion will likely
be higher among Native Americans. Diabetes control is currently suboptimal in underserved
populations such as Zuni Indians despite a plethora of new therapies. Patient empowerment is
a key determinant of diabetes control, but such empowerment can be difficult to achieve due
to resource limitation and cultural, language and health literacy barriers. The investigators
will conduct a home-based chronic disease (diabetes) educational intervention using Community
Health Representatives (CHRs) to associate improvement in Patient Activation Measures scores
(primary outcome) and clinical indicators of diabetes control (secondary outcomes).
Description:
The number of American Indians and Alaska Natives (AI/ANs) who have diabetes is growing
rapidly, especially among young people. At more than 16%, AI/ANs have the highest
age-adjusted prevalence of diabetes among all U.S. racial and ethnic groups [1]. One such
population is the Zuni Pueblo home to a small, geographically isolated tribe located in a
rural portion of New Mexico, USA. It is home to ~11,000 Zuni Indians and over 90% of all
Zunis live in the Pueblo. This socioeconomically disadvantaged population faces a major
public health challenge from growing health disparities. Changing lifestyles have led to
decreased physical activity and increased caloric intake with high consumption of fast food,
soda pop and alcohol. Therefore, the Zuni are experiencing interrelated epidemics of obesity,
diabetes, hypertension, kidney disease and intermediate phenotypes.
As part of the Zuni Health Initiative (ZHI), the investigators surveyed participants
regarding barriers to healthcare [2], with particular attention to diabetes care. In ZHI the
investigators also collected and stored clinical phenotype information and anthropological
measurements from all participants. Participants identified the following barriers: access to
care, language barriers, limited patient education, and anxiety around diagnosis, fear of
chronic disease, reluctance to participate in self-care, resistance to dietary change, and
reluctance to engage in regular exercise. The investigators have previously documented
suboptimal glycemic control with a high burden of kidney disease among the Zuni [3, 4]. The
burden presented by these barriers ultimately translates into a lack of patient activation
and engagement in their healthcare, effectively hindering adoption of healthy behaviors.
Focus groups subsequently identified common solutions to overcome some of these barriers,
including home-based care, point of care testing, individualized exercise and nutrition
prescriptions, and care providers with knowledge of the Zuni language, community and culture.
The information gathered during these focus groups [5] is used to design and implement a Zuni
culture specific educational intervention in diabetes. The investigators have devised an
innovative educational intervention based on the coordination of four key elements: (a)
delivering healthcare that incorporated collaborative communication within the healthcare
team and emphasized greater autonomy in care, adherence to the medical regimen, and
patient-centered goal setting, all while retaining the ability to address the needs of
patients, family members, the healthcare team, and/or the healthcare system; (b) providing
innovative educational and organizational approaches, as well as behavior change strategies,
that enhanced adherence; (c) addressing health beliefs that reduced adherence by over- or
under-predicting maladaptive thoughts (e.g., catastrophizing, minimizing, cognitive
dissonance, invincibility, or fatalism) or that interfered with weight control; and (d) using
technology to address barriers to achieving desired health outcomes.
Sixty participants with type 2 diabetes (T2D) completed a baseline evaluation including
physical exam, Point of Care (POC) testing, and the Patient Activation Measure (PAM) survey.
Participants then underwent a one hour group didactic session led by Community Health
Representatives (CHRs) who subsequently carried out monthly home-based educational
interventions to encourage healthy lifestyles, including diet, exercise, and alcohol and
cigarette avoidance until follow up at 6 months, when clinical phenotyping and the PAM survey
were repeated.
