Type2 DiabetesNCT04210024
Social Network Analysis to Identify Community Health Workers
A study testing Diabetes Empowerment Education Program in people with Type2 Diabetes, run by Brittany L Smalls at 2 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- Diabetes Empowerment Education Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 May 2019to 10 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- residents of Leslie County, Kentucky
- speak and understand English
Who cannot join
- under 18 years of age
- unable to speak and understand English
- unable to consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UK Center for Excellence in Rural Health, Kentucky Homeplace
Hyden, Kentucky, 41749
Stinnett Area Community Center
Stinnett, Kentucky, 40868
About this study
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.
Read the 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.
- Conditions
- Type2 Diabetes
- Being tested
- Diabetes Empowerment Education Program
- Keywords
- Diabetes Empowerment Education Program (DEEP), social network analysis, Integrated Behavioral Model (IBM), rural, community, Appalachia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Empowerment Education ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Diabetes Empowerment Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start3 May 2019
- Primary completion10 Aug 2023
- Study completion10 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brittany L Smalls
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Brittany L Smalls, University of Kentucky
- Investigators
- Brittany Smalls, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210024
- Sponsor's protocol ID
- 45657
- Other IDs
- 1K01DK116923
- Status last verified
- Nov 2024
- First submitted
- 20 Dec 2019
- Last updated
- 3 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Network Analysis to Identify Community Health Workers
- ClinicalTrials.gov ID
- NCT04210024
- Acronym / sponsor ID
- 45657
- Conditions
- Type2 Diabetes
- Keywords
- Diabetes Empowerment Education Program (DEEP), social network analysis, Integrated Behavioral Model (IBM), rural, community, Appalachia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Brittany L SmallsUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 3 May 2019 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 10 Aug 2023 (actual)
- First posted
- 24 Dec 2019 (actual)
- Results
- Posted 3 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rural-Dwelling Community Members/Residents | Other | Other: Diabetes Empowerment Education ProgramRural-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). |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- residents of Leslie County, Kentucky
- speak and understand English
Key exclusion criteria (3 listed)
- under 18 years of age
- unable to speak and understand English
- unable to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetes Empowerment Education ProgramIndividuals 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. | Other | Rural-Dwelling Community Members/Residents |
Primary outcome
Change in Diabetes Knowledge
Time frame: 6 weeks
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.
Change in Health Literacy
Time frame: 6 weeks
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brittany Smalls, PhD principal investigator
University of Kentucky
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Empowerment Education Program in people with Type2 Diabetes, run by Brittany L Smalls at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Diabetes Knowledge (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.