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COMPAR-EU RCTs Web

The Cholesterol, Hypertension, And Glucose Education (CHANGE) study: results from a randomized controlled trial in African Americans with diabetes

Author: Crowley, M. J. Country/countries: N/A Number of patients participating in the study: 359 This study was focused on patients living with Type 2 Diabetes Mellitus
Intervention analysed in the study: Usual Care Plus Intervention components: UCP
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Setting of implementation: N/A Professionals delivering the intervention: N/A Targeted self-management behaviours: N/A
Intervention analysed in the study: Monitoring, action-based and emotional-based behavioural techniques and social support delivered remotely Intervention components: E+MT+AB+EB+SS+R
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Setting of implementation: Home-care Professionals delivering the intervention: Nurses Targeted self-management behaviours: Cessation or reduction of alcohol and other harmful consumptions, Eating behaviours, Medication use and adherence, Physical activity /exercise, Self-monitoring, Smoking cessation or reduction

Outcomes measured in the study

Outcome Measure Tool
Adherence Medication (or other treatment) adherence Adherence Starts with Knowledge (ASK-20)
Blood-pressure Systolic pressure N/A
HbA1C Glycated hemoglobin (HbA1c) N/A
Lipid profile LDL-Cholesterol N/A

Patient characteristics

Age: 56.49 years (+/- a standard deviation of 12.0) Gender: 72.14% female Time since diagnosis of Type 2 Diabetes Mellitus: N/A Severity of the disease: 8.0 (+/- a standard deviation of 1.34) Multi-morbidity: N/A
  • Number of co-morbidities: 1.0

Level of health literacy: N/A
  • Tool: N/A

Socio-economic characteristics: N/A

Risk of Bias of this study

Outcome Random sequence generation Allocation concealment Blinding performance Blinding detection objective outcomes assessment Attrition incomplete outcome Incorrect statistical methods Recruitment bias Selective outcome reporting
Adherence - Medication (or other treatment) adherence
Blood-pressure - Systolic pressure
HbA1C - Glycated hemoglobin (HbA1c)
Lipid profile - LDL-Cholesterol

Other publications associated with this study

The Cholesterol, Hypertension, and Glucose Education (CHANGE) study for African Americans with diabetes: Study design and methodology Link: 10.1016/j.ahj.2009.06.026