Clinical trial NCT04568486: Social Support Intervention for Older Adults With T2DM
Official title: Seed-alter Dyad Social Support Intervention for Rural Dwelling Older Adults With T2DM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-09-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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" Exclusion Criteria

* under 18 years of age
* unable to speak and understand English
* unable to consent

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: 12 months
Secondary outcomes:
measure: Systolic Blood Pressure
timeFrame: 12 months
measure: Diastolic Blood Pressure
timeFrame: 12 months
measure: Lipids
timeFrame: 6 weeks
measure: Self-care
timeFrame: 12 months
measure: Medication Adherence
timeFrame: 12 months
measure: Health-related Quality of Life Measures
timeFrame: 12 months
Other outcomes:
Locations:
city: Hyden
country: United States
facility: UK Center for Excellence in Rural Health, Kentucky Homeplace
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Brittany Smalls, PhD
role: PRINCIPAL_INVESTIGATOR
References: