NCT04568486

Social Support Intervention for Older Adults With T2DM

Completed NA Results posted Last updated 13 February 2025

What this trial tests

NA trial testing Diabetes Empowerment Education Program in Type 2 Diabetes in 90 participants. Completed in 31 March 2024.

Timeline

1 October 2020

Primary endpoint
31 December 2023

31 March 2024

Quick facts

Lead sponsor	Brittany L Smalls
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	90
Start date	1 October 2020
Primary completion	31 December 2023
Estimated completion	31 March 2024
Sites	1 location across United States

Drugs / interventions tested

• Diabetes Empowerment Education Program

Conditions studied

• Type 2 Diabetes — all drugs for Type 2 Diabetes →

Sponsor

Brittany L Smalls

Who can join

Adults 18 to 99, any sex, with Type 2 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Hemoglobin A1c Primary · 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.

Baseline

Group	Value	95% CI
Rural-dwelling Older Adults (Seed) and Key Players (Alter	7.004	± 1.19

6 months

Group	Value	95% CI
Rural-dwelling Older Adults (Seed) and Key Players (Alter	6.24	± 1.19

12 months

Group	Value	95% CI
Rural-dwelling Older Adults (Seed) and Key Players (Alter	6.47	± 1.05

Systolic Blood Pressure Secondary · 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.

Baseline

Group	Value	95% CI
Rural-dwelling Older Adults (Seed) and Key Players (Alter	127.59	± 15.23

6 months

Group	Value	95% CI
Rural-dwelling Older Adults (Seed) and Key Players (Alter	129.57	± 17.82

12 months

Group	Value	95% CI
Rural-dwelling Older Adults (Seed) and Key Players (Alter	129.71	± 15.07

Diastolic Blood Pressure Secondary · 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.

Baseline

Group	Value	95% CI
Rural-dwelling Older Adults (Seed) and Key Players (Alter	73.59	± 11.97

6 months

Group	Value	95% CI
Rural-dwelling Older Adults (Seed) and Key Players (Alter	77.42	± 7.46

12 months

Group	Value	95% CI
Rural-dwelling Older Adults (Seed) and Key Players (Alter	77.28	± 10.59

Self-care Secondary · 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

Baseline

Group	Value	95% CI
Rural-dwelling Older Adults (Seed) and Key Players (Alter	6.93	± 1.50

6 montns

Group	Value	95% CI
Rural-dwelling Older Adults (Seed) and Key Players (Alter	8.08	± 1.03

12 months

Group	Value	95% CI
Rural-dwelling Older Adults (Seed) and Key Players (Alter	8.75	± 1.13

Medication Adherence Secondary · 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.

Baseline

Group	Value	95% CI
Rural-dwelling Older Adults (Seed) and Key Players (Alter	0.84	± 1.06

6 months

Group	Value	95% CI
Rural-dwelling Older Adults (Seed) and Key Players (Alter	0.60	± 0.75

12 months

Group	Value	95% CI
Rural-dwelling Older Adults (Seed) and Key Players (Alter	0.57	± 0.78

Health-related Quality of Life Measures Secondary · 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.

Baseline

Group	Value	95% CI
Rural-dwelling Older Adults (Seed) and Key Players (Alter	9.45	± 3.07

6 months

Group	Value	95% CI
Rural-dwelling Older Adults (Seed) and Key Players (Alter	9.20	± 3.33

12 months

Group	Value	95% CI
Rural-dwelling Older Adults (Seed) and Key Players (Alter	9.14	± 2.67

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.