Zuni Health Initiative - Chronic Disease Education

NCT02339311 | Terminated

• 1 other identifier: 10-249
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Diabetes

Keywords

The study focus is on lifestyle changes and patient activation in diabetic patients by regular monthly visit by the CHRs

Outcome Measures

Primary Outcomes (1)

• Patient Activation

  The Patient Activation Measure (PAM) instrument completed by participants using the short form PAM questionnaire \[16, 17\]. The response options for the 13 questions use a categorical agreement scale with 4 response options: (i) strongly disagree, (ii) disagree, (iii) agree, (iv) strongly agree, and N/A. The raw score is calculated by adding responses to the 13 questions. If all questions are answered (i.e., no "N/A" is used), the range of raw scores would be 13 to 52. If there is at least 1 item with a response of N/A, the total score will be divided by the number of items completed and multiplied by 13 to yield a normalized raw score. All study procedures were repeated 6-months later, following the intervention.

  6 months

Secondary Outcomes (1)

• Diabetes associated health indicators

  six months

Interventions

Educational intervention of Lifestyle and patient activation in diabetics OTHER

Participants 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

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of New Mexico: lead

Related Publications (1)

• 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.

  PMID: 25954817 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Vallabh Shah, PhD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2015
• First Posted: January 15, 2015
• Study Start: June 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 10, 2024

Record last verified: 2024-01