Skip to main content
OpenTrials
Completed

NCT Number: NCT04795050

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Health Promotion

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida State University College of Nursing

Tallahassee, Florida, 32306-4310, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PROJECT POWER

Behavioral

Diabetes health promotion/cardiovascular disease risk reduction educational curriculum

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  1. Diabetes Fatalism

    Time frame: Baseline 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.

  2. Perceived Diabetes Self-Management

    Time frame: Baseline 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.

  3. Social Support

    Time frame: Baseline 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.

  4. Change from Baseline Diabetes Fatalism at Three Weeks

    Time frame: Baseline 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.

  5. Change from Baseline Perceived Diabetes Self-Management at Three Weeks

    Time frame: Baseline 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.

  6. Change from Baseline Social Support at Three Weeks

    Time frame: Baseline 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.

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 12, 2021
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.