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Clinical Trials/NCT04795050
NCT04795050
Completed
Not Applicable

Mitigating Cardiovascular Disease Risk Among Rural Diabetics

Florida State University1 site in 1 country146 target enrollmentMay 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Health Promotion
Sponsor
Florida State University
Enrollment
146
Locations
1
Primary Endpoint
Diabetes Self-care Activities
Status
Completed
Last Updated
10 months ago

Overview

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.

Detailed Description

An experimental pretest-posttest control group design was used to assess the effects of a diabetes health promotion intervention among participants recruited from rural churches located in the southern United States. The intervention, called Project Power, is a culturally relevant, church-based diabetes education program that was developed by the American Diabetes Association (ADA). Participating churches were randomized to experimental and control groups using random numbers tables having numerical parity no greater than 2. Since an individual church is the unit of randomization, all of the participants in that church received the same treatment condition. Churches randomized to the intervention group received the health promotion program, and those designated to the control group received an educational brochure. Recruitment, data collection and intervention delivery, for the intervention group, occurred on the church grounds.

Registry
clinicaltrials.gov
Start Date
May 1, 2018
End Date
October 31, 2018
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Laurie Abbott

Assistant Professor

Florida State University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Diabetes Self-care Activities

Time Frame: Baseline

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.

Diabetes Knowledge

Time Frame: Baseline

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.

Change from Baseline Diabetes Self-care Activities at Three Weeks

Time Frame: Three weeks after baseline

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.

Change from Baseline Diabetes Knowledge at Three Weeks

Time Frame: Three weeks after baseline

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.

Secondary Outcomes

  • 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)
  • Change from Baseline Social Support at Three Weeks(Baseline and three weeks later)
  • Diabetes Fatalism(Baseline and three weeks later)
  • Perceived Diabetes Self-Management(Baseline and three weeks later)

Study Sites (1)

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