Mitigating Cardiovascular Disease Risk Among Rural Diabetics

Health Promotion Clinical Trial

Official title:

Mitigating Cardiovascular Disease Risk Among Rural Diabetics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04795050
• Other study ID #: HSC # 2018 23127
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: October 31, 2018

Study information

• Verified date: March 2021
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Health Promotion

Intervention

Behavioral:
• Project POWER
Diabetes health promotion/cardiovascular disease risk reduction educational curriculum

Locations

Country	Name	City	State
United States	Florida State University College of Nursing	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 (a = .71). The scores ranged from a minimum of 0 to a maximum of 105. Higher scores indicated better diabetes self-care.	Baseline
Primary	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 (a = .77) and the insulin use subscale (a = .84). The twenty scored items were worth 5 points each for a maximum of 100 points total. Higher scores indicated higher knowledge levels.	Baseline
Primary	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 (a = .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
Primary	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 (a = .77) and the insulin use subscale (a = .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	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 (a = .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
Secondary	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 (a = .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
Secondary	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 (a = .91 - .97). The possibility of ranges were between 19 and 95, and higher scores indicated higher social support.	Baseline and three weeks later
Secondary	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 (a = .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
Secondary	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 (a = .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
Secondary	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 (a = .91 - .97). The possibility of ranges were between 19 and 95, and higher scores indicated higher social support.	Baseline and three weeks later