Skip to content

Mitigating Cardiovascular Disease Risk Among Rural Diabetics

Mitigating Cardiovascular Disease Risk Among Rural Diabetics

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04795050
Enrollment
146
Registered
2021-03-12
Start date
2018-05-01
Completion date
2018-10-31
Last updated
2025-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Promotion

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.

Interventions

BEHAVIORALProject POWER

Diabetes health promotion/cardiovascular disease risk reduction educational curriculum

Sponsors

Florida State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Cluster randomized trial

Eligibility

Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Diabetes Self-care ActivitiesBaselineThe 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 KnowledgeBaselineThe 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 baselineThe 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 baselineThe 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

MeasureTime frameDescription
Change from Baseline Perceived Diabetes Self-Management at Three WeeksBaseline and three weeks laterThe 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.
Diabetes FatalismBaseline and three weeks laterThe 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 Social Support at Three WeeksBaseline and three weeks laterThe 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.
Perceived Diabetes Self-ManagementBaseline and three weeks laterThe 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.
Social SupportBaseline and three weeks laterThe 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 laterThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026