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COMPAR-EU RCTs Web

COMRADE: A randomized trial of an individually tailored integrated care intervention for uncontrolled type 2 diabetes with depression and/or distress in the rural southeastern US

Author: Lutes, L. D. Country/countries: N/A Number of patients participating in the study: 139 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: Outpatient care (hospital) Professionals delivering the intervention: Nurses Targeted self-management behaviours: Condition-specific behaviours
Intervention analysed in the study: Monitoring, action-based and emotional-based behavioural techniques and social support Intervention components: E+MT+AB+EB+SS
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Setting of implementation: Outpatient care (hospital) Professionals delivering the intervention: Community Health Worker, Nurses Targeted self-management behaviours: Condition-specific behaviours, Eating behaviours, Handling /managing emotions, Self-monitoring

Outcomes measured in the study

Outcome Measure Tool
Adherence Medication (or other treatment) adherence N/A
Blood-pressure Systolic pressure N/A
HbA1C Glycated hemoglobin (HbA1c) N/A
Quality of life Psychological distress Diabetes Distress Scale (DDS)
Self-management behaviours Self-management behaviours N/A
Weight (management) Weight (Kgs/lbs) N/A

Patient characteristics

Age: 53.73 years (+/- a standard deviation of 9.48) Gender: 77.7% female Time since diagnosis of Type 2 Diabetes Mellitus: N/A Severity of the disease: 9.61 (+/- a standard deviation of 1.95) 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
Blood-pressure - Systolic pressure
HbA1C - Glycated hemoglobin (HbA1c)
Weight (management) - Weight (Kgs/lbs)

Other publications associated with this study

Randomized Trial of a Tailored Cognitive Behavioral Intervention in Type 2 Diabetes With Comorbid Depressive and/or RegimenRelated Distress Symptoms: 12-Month Outcomes From COMRADE Link: 10.2337/dc18-1841