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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04210024
Other study ID # 45657
Secondary ID 1K01DK116923
Status Completed
Phase N/A
First received
Last updated
Start date May 3, 2019
Est. completion date August 10, 2023

Study information

Verified date October 2023
Source University of Kentucky
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to recruit influential community members using Snowball Sampling Methods. Community members identified through social network analysis as influential and well-connected will be trained as community health workers (CHW) using the Diabetes Empowerment Education Program (DEEP). These CHW will be used in a future trial to educate other members of the community.


Description:

The proposed research employs the Integrated Behavior Model (IBM) to address fundamental drivers of behavior for older rural-dwelling adults with type-two diabetes mellitus (T2DM) in the context of their social network. Social network analysis (SNA) is characterized as the examination and interpretation of relational connections. This approach can be used to map social networks and understand relationships between individuals as it pertains to social support. Snowball recruitment methods will be used to recruit participants in this study. In Aim 1, individuals who are connected to several individuals within their community and have the capacity to influence norms that hinder T2DM self-care will be identified. Ten individuals who have received medical care from the Center of Excellence in Rural Health (CERH) within the past 12 months will be identified. Initial recruitment will be conducted by a community liaison in Leslie County. This core group of 10 "seeds" will be used to conduct the first wave of interviews. Since the aim of social network analysis is to understand a community by mapping the relationships that connect them as a network, each seed will be asked to identify 3 persons believed to be influential in their community. Those who are identified in wave 1 will also be asked to identify 3 people each from their community who are also respected as leaders and can be trusted to provide health-related information to community members. This process will continue for 4 waves of recruitment (N˜200). Participants will be asked to provide demographic information including age, sex, race/ethnicity, education, employment status, contact information (address, telephone number, email). An interview guide will be adapted from a previously published intervention assessing social networks and health behavior informed by preliminary data and the expert opinion of my team of mentors and collaborators. The interviews will begin with two broad general questions asking "who" is included in their social network and "how" members of the social network provide social support; using open-ended questions to elicit maximal information with minimal bias. Interview questions will explore the following domains: size and structure of social network; resources available through social network; beliefs of those in social network regarding general healthy behavior; knowledge of available healthy lifestyle choices; and perceived acceptable healthy behaviors (social norms). Data will be collected from CHWs pre- and post-training to assess the following: T2DM knowledge: Diabetes Knowledge Questionnaire (DKQ) a 24-item survey that has a reliability coefficient of 0.78 and showed sensitivity to a T2DM knowledge intervention. Health literacy: Newest Vital Sign (NVS) is a 6-item survey to assess health literacy comprehension and numeracy. Means and paired t-tests will be conducted to determine if health literacy and T2DM knowledge improved in each CHW during the DEEP training.


Recruitment information / eligibility

Status Completed
Enrollment 98
Est. completion date August 10, 2023
Est. primary completion date August 10, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - residents of Leslie County, Kentucky - speak and understand English Exclusion Criteria: - under 18 years of age - unable to speak and understand English - unable to consent

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Diabetes Empowerment Education Program
Individuals identified as Community Health Workers will participate in the Diabetes Empowerment Education Program (DEEP™). DEEP, is an education curriculum designed to help people with pre-diabetes, diabetes, relatives and caregivers gain a better understanding of diabetes self-care. Classes last a total of six weeks, providing participants with eight unique learning modules. Health literacy will be assessed before and after participating in DEEP.

Locations

Country Name City State
United States UK Center for Excellence in Rural Health, Kentucky Homeplace Hyden Kentucky
United States Stinnett Area Community Center Stinnett Kentucky

Sponsors (2)

Lead Sponsor Collaborator
Brittany L Smalls National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Diabetes Knowledge The change in participants' knowledge of Type 2 Diabetes Mellitus (T2DM) will be assessed using the Diabetes Knowledge Questionnaire (DKQ) pre- and post-training with the DEEP program. The DKQ is a 24-item survey assessing diabetes knowledge. Scores range from 0-24; higher scores indicate increased knowledge of diabetes. 6 weeks
Primary Change in Health Literacy Change in health literacy pre- and post-education with the DEEP program will be assessed using the Newest Vital Sign (NVS) survey tool. NVS assesses health literacy based on participant interpretation of food labels. Scores range from 0-6. Lower scores indicate a high likelihood of limited literacy while higher scores indicate adequate literacy. 6 weeks
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