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| ID | Type | Description | Link |
|---|---|---|---|
| 1K01DK116923 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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 (NËś200).
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 supportÍľ using open-ended questions to elicit maximal information with minimal bias. Interview questions will explore the following domains: size and structure of social networkÍľ resources available through social networkÍľ beliefs of those in social network regarding general healthy behaviorÍľ knowledge of available healthy lifestyle choicesÍľ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rural-Dwelling Community Members/Residents | Other | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diabetes Empowerment Education Program | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brittany Smalls, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UK Center for Excellence in Rural Health, Kentucky Homeplace | Hyden | Kentucky | 41749 | United States | ||
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Due to covid, the study was paused by the institutions for 18 months. In order to get back on track with the intervention, we could not identify and train community health workers to participate in the study based on the data collected for social network analysis. Alternatively, the research coordinator administered the intervention. There were no community health works.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). This was a cohort study/community assessment and there were no study arms. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age for one participant was missing |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Data not collected for this outcome | Posted | 6 weeks |
|
6 weeks
No adverse event data to report
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brittany Smalls | University of Kentucky | 859-323-4916 | brittany.smalls@uky.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 26, 2022 | Jul 11, 2024 | Prot_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 13, 2022 | Oct 31, 2023 | ICF_000.pdf |
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|
| Stinnett Area Community Center |
| Stinnett |
| Kentucky |
| 40868 |
| United States |
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | 1 participant did not report this demographic | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Education | Count of Participants | Participants |
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| Employment Status | Count of Participants | Participants |
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| Insurance | Count of Participants | Participants |
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| Difficulty understanding or speaking English | Count of Participants | Participants |
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| Reading or writing English | Count of Participants | Participants |
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| Marital Status | 1 participant did not report this demographic | Count of Participants | Participants |
|
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| 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. | Data not collected for this outcome | Posted | 6 weeks |
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| 0 |
| 91 |
| 0 |
| 91 |
| 0 |
| 91 |
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