Mitigating Cardiovascular Disease Risk Among Rural Diabetics

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.

Study Overview

• Status: Completed
• Conditions: Health Promotion
• Intervention / Treatment: Behavioral: Project POWER

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.

• Study Type: Interventional
• Enrollment (Actual): 146
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32306-4310
      • Florida State University College of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention	Behavioral: Project POWER; Diabetes health promotion/cardiovascular disease risk reduction educational curriculum
No Intervention: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diabetes Fatalism	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.	Baseline and three weeks later
Perceived Diabetes Self-Management	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.	Baseline and three weeks later
Social Support	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.	Baseline and three weeks later
Change from Baseline Diabetes Fatalism at Three Weeks	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.	Baseline and three weeks later
Change from Baseline Perceived Diabetes Self-Management at Three Weeks	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.	Baseline and three weeks later
Change from Baseline Social Support at Three Weeks	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.	Baseline and three weeks later

Collaborators and Investigators

• Sponsor: Florida State University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): October 31, 2018
• Study Completion (Actual): October 31, 2018

Study Registration Dates

• First Submitted: March 9, 2021
• First Submitted That Met QC Criteria: March 10, 2021
• First Posted (Actual): March 12, 2021

Study Record Updates

• Last Update Posted (Actual): March 12, 2021
• Last Update Submitted That Met QC Criteria: March 10, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: HSC # 2018 23127

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No