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| ID | Type | Description | Link |
|---|---|---|---|
| K01DK116923 | 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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This study seeks to describe and evaluate the impact of social support on self-care and clinical outcomes in rural-dwelling older adults with T2DM, test the feasibility and preliminary effectiveness of a 6-week intervention administered by community health workers targeting rural dwelling older adults with T2DM (seed) and an individual within their social support network (alter).
A mixed-methods approach will be used to map social networks of older adults and assess their perceived social support from members of their social network and determine its influence on self-care and clinical outcomes. We will conduct semi-structured interviews with older rural-dwelling adults to map their social network structure, determine the types of social support provided by members of their SN, and identify key players within the older adults' personal network. For this aim, key players are those who can facilitate and promote T2DM self-care on an individual level. These older adults will form a dyad with their alter to participate in a multilevel intervention which includes: gauging the feasibility of using community health workers identified via social network analysis to conduct self-care sessions in rural communities, and the feasibility of seed-alter dyads to provide social support that improves self-care in older adults.
In addition, the seed-alter dyad will participate in 6 weekly sessions of a diabetes education program, led by the community health workers identified previously. Participants will be asked to complete surveys at baseline, 6, and 12 months to assess social support, participants' knowledge about diabetes, and how participants are managing their diabetes.
The preliminary data used for this K01 application was collected from the BRFSS where data is self-reported and its accuracy cannot be confirmed, and a dataset where social support was not the primary objective of the study and there was a small sample size all older adults. Yet, there remains a body of literature that substantiates the influence of social support on T2DM self-care and the disproportionate burden of T2DM in older adults. The proposed research will provide a comprehensive overview of the role of social support and how to leverage this support in a rural community.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rural-dwelling older adults (seed) and Key players (alter | Other | Rural-dwelling older 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. This group will be paired with their key players (identified during interviews) to receive the diabetes education. The pair complete the intervention as a dyad. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diabetes Empowerment Education Program | Other | The Diabetes Empowerment Education Program (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 |
|---|---|---|
| Hemoglobin A1c | The change in participants' hemoglobin A1c measures will be abstracted from their medical records pre- and post-training with the DEEP program. Improved hemoglobin A1c figures suggest an overall success of the DEEP program and a better ability for patients to manage their diabetes. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure | Participants' systolic and diastolic blood pressures will be abstracted from their medical records pre- and post-training with the DEEP program. Improved blood pressure outcomes suggest an overall success of the DEEP program and a better ability for patients to manage their diabetes. | 12 months |
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"Seeds" Inclusion Criteria:
"Seeds" Exclusion Criteria:
"Alters" Inclusion Criteria
"Alters" 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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Seeds: Older adults will be primarily recruited from the University of Kentucky (UK) Center of Excellence in Rural Health clinic.
Alters: As a result of social network analysis of individual older adults (seeds), a member of the social network (alter) will be identified to participate in as a seed-alter dyad social support intervention.
The seed and alter must be consented to participate in the intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rural-dwelling Older Adults (Seed) and Key Players (Alter | Rural-dwelling older 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. This group will be paired with their key players (identified during interviews) to receive the diabetes education. The pair complete the intervention as a dyad. Diabetes Empowerment Education Program: The Diabetes Empowerment Education Program (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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Demographics for the seed group were collected for up to 60 participants. Demographics for the alter group were collected for 23 participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Rural-dwelling Older Adults (Seed) and Key Players (Alter | Rural-dwelling older 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. This group will be paired with their key players (identified during interviews) to receive the diabetes education. The pair complete the intervention as a dyad. Diabetes Empowerment Education Program: The Diabetes Empowerment Education Program (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 |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | number of participants with data collected for this demographic |
| 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 | Hemoglobin A1c | The change in participants' hemoglobin A1c measures will be abstracted from their medical records pre- and post-training with the DEEP program. Improved hemoglobin A1c figures suggest an overall success of the DEEP program and a better ability for patients to manage their diabetes. | only seed data are reported for this outcome; number of participants measured for this outcome at each time point (56, 21, and 7 respectively) | Posted | Mean | Standard Deviation | percentage of hemoglobin | 12 months |
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deaths, serious adverse events, and nonserious adverse events were not assessed for study participants
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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 Older Adults (Seed) and Key Players (Alter | Rural-dwelling older 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. This group will be paired with their key players (identified during interviews) to receive the diabetes education. The pair complete the intervention as a dyad. Diabetes Empowerment Education Program: The Diabetes Empowerment Education Program (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 | |
|---|---|---|---|---|
| Brittany Smalls | University of Kentucky | 859-323-4916 | brittany.smalls@uky.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 12, 2024 | Nov 25, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 8, 2024 | Apr 17, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Diastolic Blood Pressure |
Participants' systolic and diastolic blood pressures will be abstracted from their medical records pre- and post-training with the DEEP program. Improved blood pressure outcomes suggest an overall success of the DEEP program and a better ability for patients to manage their diabetes. |
| 12 months |
| Lipids | Participants' lipids measures will be abstracted from their medical records pre- and post-training with the DEEP program. Improved lipids outcomes suggest an overall success of the DEEP program and a better ability for patients to manage their diabetes. | 6 weeks |
| Self-care | The Diabetes self-care management questionnaire consist of 16 questions and sum score was calculated by adding all 16 items. Sum scaled score was computed as actual sum of items/ maximum possible sum of items * 10. The transformed score ranged from 0-10. Higher scores indicating better self-management | 12 months |
| Medication Adherence | Participants' medication adherence will be measured from the Brooks Medication Adherence Scale. It measures medication adherence and consists of 6 questions. The total score ranged from 0-6. Less score is associated with being adherent to the medication. | 12 months |
| Health-related Quality of Life Measures | Participants' overall quality of life will be measured with a validated quality of life measure (EuroQol-5D) along 5 dimensions including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The Euro Quality of life questionnaire used 5 questions. The total score was computed by adding the responses for all 5 questions. The total scores ranged from 5 -25. Higher scores is associated with poor quality of life. | 12 months |
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | number of participants with data collected for this demographic | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | data only reported by 3 participants in the seed group and 1 participant in the alter group for this demographic | Count of Participants | Participants |
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| Race (NIH/OMB) | number of participants reporting this demographic | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Systolic Blood Pressure | Participants' systolic and diastolic blood pressures will be abstracted from their medical records pre- and post-training with the DEEP program. Improved blood pressure outcomes suggest an overall success of the DEEP program and a better ability for patients to manage their diabetes. | only seed data are reported for this outcome; participants with data for the outcome measure at each time point (58, 21, and 7 respectively) | Posted | Mean | Standard Deviation | mmHg | 12 months |
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| Secondary | Diastolic Blood Pressure | Participants' systolic and diastolic blood pressures will be abstracted from their medical records pre- and post-training with the DEEP program. Improved blood pressure outcomes suggest an overall success of the DEEP program and a better ability for patients to manage their diabetes. | only seed data are reported for this outcome; participants with data for the outcome measure at each time point (58, 21, and 7 respectively) | Posted | Mean | Standard Deviation | mmHg | 12 months |
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| Secondary | Lipids | Participants' lipids measures will be abstracted from their medical records pre- and post-training with the DEEP program. Improved lipids outcomes suggest an overall success of the DEEP program and a better ability for patients to manage their diabetes. | Lipid measures were to be done either using electronic medical records or with a point-of-care (fingerstick) device. Due to HIPAA concerns during IRB approval, investigators decided to rely fully on the fingerstick approach to measuring lipids rather than medical records. At study start up, the fingerstick device intended for use was no longer available for purchase. Therefore, lipids were not collected as part of the study. | Posted | 6 weeks |
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| Secondary | Self-care | The Diabetes self-care management questionnaire consist of 16 questions and sum score was calculated by adding all 16 items. Sum scaled score was computed as actual sum of items/ maximum possible sum of items * 10. The transformed score ranged from 0-10. Higher scores indicating better self-management | only seed data are reported for this outcome; participants with data for the outcome measure at each time point (59, 20, and 7 respectively) | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | Medication Adherence | Participants' medication adherence will be measured from the Brooks Medication Adherence Scale. It measures medication adherence and consists of 6 questions. The total score ranged from 0-6. Less score is associated with being adherent to the medication. | only seed data are reported for this outcome; participants with data for the outcome measure at each time point (58, 20, and 7 respectively) | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | Health-related Quality of Life Measures | Participants' overall quality of life will be measured with a validated quality of life measure (EuroQol-5D) along 5 dimensions including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The Euro Quality of life questionnaire used 5 questions. The total score was computed by adding the responses for all 5 questions. The total scores ranged from 5 -25. Higher scores is associated with poor quality of life. | only seed data are reported for this outcome; participants with data for the outcome measure at each time point (57, 20, and 7 respectively) | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D004700 | Endocrine System Diseases |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 12 months |
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| 12 months |
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| 12 months |
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| 12 months |
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| 12 months |
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