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Completed

NCT Number: NCT04568486

Social Support Intervention for Older Adults With T2DM

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).

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UK Center for Excellence in Rural Health, Kentucky Homeplace

Hyden, Kentucky, 41749, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

"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

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Systolic Blood Pressure

    Time frame: 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.

  2. Diastolic Blood Pressure

    Time frame: 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.

  3. Lipids

    Time frame: 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.

  4. Self-care

    Time frame: 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

  5. Medication Adherence

    Time frame: 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.

  6. Health-related Quality of Life Measures

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Brittany L Smalls

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Sep 29, 2020
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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