Social Support Intervention for Older Adults With T2DM

Sponsor
Brittany L Smalls (Other)
Overall Status
Recruiting
CT.gov ID
NCT04568486
Collaborator
(none)
262
1
1
26.9
9.7

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Diabetes Empowerment Education Program
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
262 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Seed-alter Dyad Social Support Intervention for Rural Dwelling Older Adults With T2DM
Actual Study Start Date :
Oct 1, 2020
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. Hemoglobin A1c [6 weeks]

    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 Outcome Measures

  1. Blood pressure [6 weeks]

    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.

  2. 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.

  3. Self-care [6 weeks]

    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.

  4. Medication adherence [6 weeks]

    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.

  5. Health-related quality of life measures [6 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

"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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UK Center for Excellence in Rural Health, Kentucky Homeplace Hyden Kentucky United States 41749

Sponsors and Collaborators

  • Brittany L Smalls

Investigators

  • Principal Investigator: Brittany Smalls, PhD, University of Kentucky

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Brittany L Smalls, Assistant Professor, University of Kentucky
ClinicalTrials.gov Identifier:
NCT04568486
Other Study ID Numbers:
  • 45777
First Posted:
Sep 29, 2020
Last Update Posted:
Dec 14, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Dec 14, 2021