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Mitigating Cardiovascular Disease Risk Among Rural Diabetics

Not Applicable
Completed
Conditions
Health Promotion
Interventions
Behavioral: Project POWER
Registration Number
NCT04795050
Lead Sponsor
Florida State University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
146
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
InterventionProject POWER-
Primary Outcome Measures
NameTimeMethod
Diabetes Self-care ActivitiesBaseline

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 KnowledgeBaseline

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 WeeksThree 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 WeeksThree 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 Outcome Measures
NameTimeMethod
Social SupportBaseline and three weeks later

The Medical Outcomes Study Social Support Survey (Sherbourne \& Stewart, 1991) is a instrument that has one fill-in-the-blank and 19 Likert scale, 5-point items that range from "None of the Time" (1) to "All of the Time" (5). The four social support subscales have excellent reliabilities (α = .91 - .97). The possibility of ranges were between 19 and 95, and higher scores indicated higher social support.

Change from Baseline Diabetes Fatalism at Three WeeksBaseline and three weeks later

The Diabetes Fatalism Scale (Egede \& Ellis, 2010) is a 12-item, 6-point Likert scale that measures the three constructs associated with diabetes fatalism: emotional distress, coping, and self-efficacy. The measure has excellent internal consistency (α = .83). The total score ranged from a minimum of 12 points and maximum of 72 points. Higher scores indicated greater diabetes fatalism.

Change from Baseline Perceived Diabetes Self-Management at Three WeeksBaseline and three weeks later

The Perceived Diabetes Self-Management Scale (PDSMS) (Wallston, Rothman, \& Cherrington, 2007) is an 8-item, Likert scale-type tool with responses that range from "Strongly Disagree" (1) to "Strongly Agree" (5) for each of the 8 items. The tool measures self-care perceptions and has excellent internal consistency (α = .83). The total score ranged from a minimum of 8 points and maximum of 40. Higher scores indicate greater perceptions of diabetes self-management.

Change from Baseline Social Support at Three WeeksBaseline and three weeks later

The Medical Outcomes Study Social Support Survey (Sherbourne \& Stewart, 1991) is a instrument that has one fill-in-the-blank and 19 Likert scale, 5-point items that range from "None of the Time" (1) to "All of the Time" (5). The four social support subscales have excellent reliabilities (α = .91 - .97). The possibility of ranges were between 19 and 95, and higher scores indicated higher social support.

Diabetes FatalismBaseline and three weeks later

The Diabetes Fatalism Scale (Egede \& Ellis, 2010) is a 12-item, 6-point Likert scale that measures the three constructs associated with diabetes fatalism: emotional distress, coping, and self-efficacy. The measure has excellent internal consistency (α = .83). The total score ranged from a minimum of 12 points and maximum of 72 points. Higher scores indicated greater diabetes fatalism.

Perceived Diabetes Self-ManagementBaseline and three weeks later

The Perceived Diabetes Self-Management Scale (PDSMS) (Wallston, Rothman, \& Cherrington, 2007) is an 8-item, Likert scale-type tool with responses that range from "Strongly Disagree" (1) to "Strongly Agree" (5) for each of the 8 items. The tool measures self-care perceptions and has excellent internal consistency (α = .83). The total score ranged from a minimum of 8 points and maximum of 40. Higher scores indicate greater perceptions of diabetes self-management.

Trial Locations

Locations (1)

Florida State University College of Nursing

🇺🇸

Tallahassee, Florida, United States

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