Mitigating Cardiovascular Disease Risk Among Rural Diabetics

NCT04795050 | Completed

• 1 other identifier: HSC # 2018 23127
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

The study explored the effects of the cardiovascular disease risk reduction intervention on diabetes fatalism, self-care activities, social support, knowledge, perceived self-managment among a rural population.

Conditions

Health Promotion

Outcome Measures

Primary Outcomes (4)

• Diabetes Self-care Activities

  The Summary of Diabetes Self-care Activities (SDSCA) (Toobert, Hampson, \& Glascow, 2000) includes multiple choice questions and items about self-care behaviors answered in days per week. The internal consistency of the instrument is adequate (α = .71). The scores ranged from a minimum of 0 to a maximum of 105. Higher scores indicated better diabetes self-care.

  Baseline

• Diabetes Knowledge

  The Revised Diabetes Knowledge Test: Michigan Diabetes Research Center (Fitzgerald et al., 2016) is a 23-item multiple choice diabetes knowledge test. The scale has good reliability for both the general test (α = .77) and the insulin use subscale (α = .84). The twenty scored items were worth 5 points each for a maximum of 100 points total. Higher scores indicated higher knowledge levels.

  Baseline

• Change from Baseline Diabetes Self-care Activities at Three Weeks

  The Summary of Diabetes Self-care Activities (SDSCA) (Toobert, Hampson, \& Glascow, 2000) includes multiple choice questions and items about self-care behaviors answered in days per week. The internal consistency of the instrument is adequate (α = .71). The scores ranged from a minimum of 0 to a maximum of 105. Higher scores indicated better diabetes self-care.

  Three weeks after baseline

• Change from Baseline Diabetes Knowledge at Three Weeks

  The Revised Diabetes Knowledge Test: Michigan Diabetes Research Center (Fitzgerald et al., 2016) is a 23-item multiple choice diabetes knowledge test. The scale has good reliability for both the general test (α = .77) and the insulin use subscale (α = .84). The twenty scored items were worth 5 points each for a maximum of 100 points total. Higher scores indicated higher knowledge levels.

  Three weeks after baseline

Secondary Outcomes (6)

• Diabetes Fatalism

  Baseline and three weeks later

• Perceived Diabetes Self-Management

  Baseline and three weeks later

• Social Support

  Baseline and three weeks later

• Change from Baseline Diabetes Fatalism at Three Weeks

  Baseline and three weeks later

• Change from Baseline Perceived Diabetes Self-Management at Three Weeks

  Baseline and three weeks later

Study Arms (2)

Intervention

EXPERIMENTAL

Behavioral: Project POWER

Control

NO INTERVENTION

Interventions

Project POWER BEHAVIORAL

Diabetes health promotion/cardiovascular disease risk reduction educational curriculum

Intervention

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-identified African Americans aged 22 years or older, who have been diagnosed with Diabetes Mellitus, Type 1 or 2

You may not qualify if:

• Other than African American, younger than 22 years of age

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Florida State University College of Nursing

Tallahassee, Florida, 32306-4310, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Cluster randomized trial

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 12, 2021
• Study Start: May 1, 2018
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)