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COMPAR-EU RCTs Web

Effects of stress reduction on cardiovascular risk factors in type 2 diabetes patients with early kidney disease - results of a randomized controlled trial (HEIDIS)

Author: Kopf, S. Country/countries: N/A Number of patients participating in the study: 110 This study was focused on patients living with Type 2 Diabetes Mellitus
Intervention analysed in the study: Usual Care Intervention components: UC
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Setting of implementation: Outpatient care (hospital) Professionals delivering the intervention: Physicians Targeted self-management behaviours: N/A
Intervention analysed in the study: Monitoring and emotional-based behavioural techniques delivered in groups Intervention components: E+MT+EB+G
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Setting of implementation: N/A Professionals delivering the intervention: Physicians Targeted self-management behaviours: Condition-specific behaviours, Handling /managing emotions, Medication use and adherence, Physical management, Self-monitoring

Outcomes measured in the study

Outcome Measure Tool
Blood-pressure Systolic pressure N/A
Blood-pressure Diastolic pressure N/A
HbA1C Glycated hemoglobin (HbA1c) N/A
Lipid profile LDL-Cholesterol N/A
Lipid profile HDL-Cholesterol (mmol) N/A
Lipid profile Triglycerides N/A
Quality of life Psychological distress Patient Health Questionnaire (PHQ-9)
Weight (management) BMI - Body Mass Index N/A
Weight (management) Waist/hip ratio N/A

Patient characteristics

Age: 59.01 years (+/- a standard deviation of 7.59) Gender: 24 females/86 males Time since diagnosis of Type 2 Diabetes Mellitus: N/A Severity of the disease: 7.27 (+/- a standard deviation of 1.07) Multi-morbidity: N/A
  • Number of co-morbidities: 2.0

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
Blood-pressure - Systolic pressure
Blood-pressure - Diastolic pressure
HbA1C - Glycated hemoglobin (HbA1c)
Lipid profile - LDL-Cholesterol
Lipid profile - Triglycerides
Lipid profile - HDL-Cholesterol (mmol)
Weight (management) - BMI - Body Mass Index