- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04210024
Social Network Analysis to Identify Community Health Workers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kentucky
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Hyden, Kentucky, United States, 41749
- UK Center for Excellence in Rural Health, Kentucky Homeplace
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Stinnett, Kentucky, United States, 40868
- Stinnett Area Community Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Rural-Dwelling Community Members/Residents
Rural-dwelling adults will be interviewed to map their social network structure, determine the types of social support provided by members of their social network, and identify key players within these networks.
A subset of participants (~4) will be identified as Community Health Workers and will receive training with the Diabetes Empowerment Education Program (DEEP).
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Diabetes Knowledge
Time Frame: 6 weeks
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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.
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6 weeks
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Change in Health Literacy
Time Frame: 6 weeks
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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.
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6 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Brittany Smalls, PhD, University of Kentucky
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 45657
- 1K01DK116923 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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