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Clinical Trials/NCT04568486
NCT04568486
Completed
N/A

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

Brittany L Smalls1 site in 1 country90 target enrollmentOctober 1, 2020
ConditionsType 2 Diabetes

Overview

Phase
N/A
Intervention
Not specified
Conditions
Type 2 Diabetes
Sponsor
Brittany L Smalls
Enrollment
90
Locations
1
Primary Endpoint
Hemoglobin A1c
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2020
End Date
March 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Brittany L Smalls
Responsible Party
Sponsor Investigator
Principal Investigator

Brittany L Smalls

Assistant Professor

University of Kentucky

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Hemoglobin A1c

Time Frame: 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 Outcomes

  • Diastolic Blood Pressure(12 months)
  • Systolic Blood Pressure(12 months)
  • Lipids(6 weeks)
  • Self-care(12 months)
  • Medication Adherence(12 months)
  • Health-related Quality of Life Measures(12 months)

Study Sites (1)

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