Type 2 Diabetes
Conditions
Brief summary
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).
Detailed description
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.
Interventions
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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Brittany L Smalls
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
Seeds Inclusion Criteria: * confirmed diagnosis of T2DM via electronic medical record * age 65 years or older * lives within Leslie County * able to provide consent * have had at least one clinic visit in the past year Seeds
Exclusion criteria
* no diagnosis of T2DM via electronic medical record * under 65 years of age * unable to speak and understand English * unable to consent Alters Inclusion Criteria * 18 years of age or older * able to provide consent * has at least weekly contact with the seed Alters
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diastolic Blood Pressure | 12 months | 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. |
| Lipids | 6 weeks | 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. |
| Systolic Blood Pressure | 12 months | 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. |
| Medication Adherence | 12 months | 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. |
| Health-related Quality of Life Measures | 12 months | 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. |
| Self-care | 12 months | 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 |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 83 |
| Total | 83 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 7 |
| Overall Study | Withdrawal by Subject | 26 |
Baseline characteristics
| Characteristic | Rural-dwelling Older Adults (Seed) and Key Players (Alter |
|---|---|
| Age, Continuous Alter | 60.52 years STANDARD_DEVIATION 13.07 |
| Age, Continuous Seed | 64.91 years STANDARD_DEVIATION 7.66 |
| Ethnicity (NIH/OMB) alter Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) alter Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) alter Unknown or Not Reported | 0 Participants |
| Ethnicity (NIH/OMB) seed Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) seed Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) seed Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) alter American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) alter Asian | 0 Participants |
| Race (NIH/OMB) alter Black or African American | 1 Participants |
| Race (NIH/OMB) alter More than one race | 0 Participants |
| Race (NIH/OMB) alter Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) alter Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) alter White | 21 Participants |
| Race (NIH/OMB) seed American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) seed Asian | 0 Participants |
| Race (NIH/OMB) seed Black or African American | 7 Participants |
| Race (NIH/OMB) seed More than one race | 0 Participants |
| Race (NIH/OMB) seed Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) seed Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) seed White | 46 Participants |
| Region of Enrollment United States | 83 participants |
| Sex: Female, Male alter Female | 16 Participants |
| Sex: Female, Male alter Male | 7 Participants |
| Sex: Female, Male seed Female | 33 Participants |
| Sex: Female, Male seed Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: 12 months
Population: only seed data are reported for this outcome; number of participants measured for this outcome at each time point (56, 21, and 7 respectively)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rural-dwelling Older Adults (Seed) and Key Players (Alter | Hemoglobin A1c | Baseline | 7.004 percentage of hemoglobin | Standard Deviation 1.19 |
| Rural-dwelling Older Adults (Seed) and Key Players (Alter | Hemoglobin A1c | 6 months | 6.24 percentage of hemoglobin | Standard Deviation 1.19 |
| Rural-dwelling Older Adults (Seed) and Key Players (Alter | Hemoglobin A1c | 12 months | 6.47 percentage of hemoglobin | Standard Deviation 1.05 |
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.
Time frame: 12 months
Population: only seed data are reported for this outcome; participants with data for the outcome measure at each time point (58, 21, and 7 respectively)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rural-dwelling Older Adults (Seed) and Key Players (Alter | Diastolic Blood Pressure | Baseline | 73.59 mmHg | Standard Deviation 11.97 |
| Rural-dwelling Older Adults (Seed) and Key Players (Alter | Diastolic Blood Pressure | 6 months | 77.42 mmHg | Standard Deviation 7.46 |
| Rural-dwelling Older Adults (Seed) and Key Players (Alter | Diastolic Blood Pressure | 12 months | 77.28 mmHg | Standard Deviation 10.59 |
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.
Time frame: 12 months
Population: only seed data are reported for this outcome; participants with data for the outcome measure at each time point (57, 20, and 7 respectively)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rural-dwelling Older Adults (Seed) and Key Players (Alter | Health-related Quality of Life Measures | Baseline | 9.45 score on a scale | Standard Deviation 3.07 |
| Rural-dwelling Older Adults (Seed) and Key Players (Alter | Health-related Quality of Life Measures | 6 months | 9.20 score on a scale | Standard Deviation 3.33 |
| Rural-dwelling Older Adults (Seed) and Key Players (Alter | Health-related Quality of Life Measures | 12 months | 9.14 score on a scale | Standard Deviation 2.67 |
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.
Time frame: 6 weeks
Population: 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.
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.
Time frame: 12 months
Population: only seed data are reported for this outcome; participants with data for the outcome measure at each time point (58, 20, and 7 respectively)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rural-dwelling Older Adults (Seed) and Key Players (Alter | Medication Adherence | 12 months | 0.57 score on a scale | Standard Deviation 0.78 |
| Rural-dwelling Older Adults (Seed) and Key Players (Alter | Medication Adherence | Baseline | 0.84 score on a scale | Standard Deviation 1.06 |
| Rural-dwelling Older Adults (Seed) and Key Players (Alter | Medication Adherence | 6 months | 0.60 score on a scale | Standard Deviation 0.75 |
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
Time frame: 12 months
Population: only seed data are reported for this outcome; participants with data for the outcome measure at each time point (59, 20, and 7 respectively)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rural-dwelling Older Adults (Seed) and Key Players (Alter | Self-care | Baseline | 6.93 score on a scale | Standard Deviation 1.5 |
| Rural-dwelling Older Adults (Seed) and Key Players (Alter | Self-care | 6 montns | 8.08 score on a scale | Standard Deviation 1.03 |
| Rural-dwelling Older Adults (Seed) and Key Players (Alter | Self-care | 12 months | 8.75 score on a scale | Standard Deviation 1.13 |
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.
Time frame: 12 months
Population: only seed data are reported for this outcome; participants with data for the outcome measure at each time point (58, 21, and 7 respectively)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rural-dwelling Older Adults (Seed) and Key Players (Alter | Systolic Blood Pressure | 12 months | 129.71 mmHg | Standard Deviation 15.07 |
| Rural-dwelling Older Adults (Seed) and Key Players (Alter | Systolic Blood Pressure | Baseline | 127.59 mmHg | Standard Deviation 15.23 |
| Rural-dwelling Older Adults (Seed) and Key Players (Alter | Systolic Blood Pressure | 6 months | 129.57 mmHg | Standard Deviation 17.82 |