Social Support Intervention for Older Adults With T2DM

Type 2 Diabetes Clinical Trial

Official title:

Seed-alter Dyad Social Support Intervention for Rural Dwelling Older Adults With T2DM

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04568486
• Other study ID #: 45777
• Secondary ID: K01DK116923
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: March 31, 2024

Study information

• Verified date: April 2024
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: March 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

"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" Exclusion Criteria

• under 18 years of age

• unable to speak and understand English

• unable to consent

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	UK Center for Excellence in Rural Health, Kentucky Homeplace	Hyden	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Brittany L Smalls	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	6 weeks
Secondary	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.	6 weeks
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.	6 weeks
Secondary	Self-care	Participants' results from the Diabetes Self-Management Questionnaire will be analyzed to assess self-care activities associated with glycemic control. Improved scores on the Questionnaire suggest an overall success of the DEEP program and a better ability for patients to manage their diabetes.	6 weeks
Secondary	Medication adherence	Participants' medication adherence will be measured from the Brooks Medication Adherence Scale to determine if there were changes to adherence due to the intervention. Better scores indicate improved medication adherence and suggest an overall success of the DEEP program and a better ability for patients to manage their diabetes.	6 weeks
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.	6 weeks