Clinical trial NCT02339311: Zuni Health Initiative - Chronic Disease Education
Official title: A Home-based Educational Intervention Improves Patient Activation Measures and Diabetes Health Indicators Among Zuni Indians
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Diabetes
Keywords: The study focus is on lifestyle changes and patient activation in diabetic patients by regular monthly visit by the CHRs
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2015-01-15
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population is Zuni diabetics with HbA1c level of 6.6% and above in the age range of 21 yrs to 75 yrs old lining in Zuni Pueblo.

Brief 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).

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Diabetes with HbA1c greater than 6.6%
* Zuni Native only
* Age 21-75 yrs
* on diabetes medication

Exclusion Criteria:

* Non-Zuni Native
* Non-diabetic
* Not able to consent

Primary outcomes:
measure: Patient Activation
timeFrame: 6 months
Secondary outcomes:
measure: Diabetes associated health indicators
timeFrame: six months
Other outcomes:
Locations:
Study officials:
affiliation: University of New Mexico
name: Vallabh Shah, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shah VO, Carroll C, Mals R, Ghahate D, Bobelu J, Sandy P, Colleran K, Schrader R, Faber T, Burge MR. A Home-Based Educational Intervention Improves Patient Activation Measures and Diabetes Health Indicators among Zuni Indians. PLoS One. 2015 May 8;10(5):e0125820. doi: 10.1371/journal.pone.0125820. eCollection 2015.