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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, LD Country/countries: United States Number of patients participating in the study: 139 This study was focused on patients living with Obesity
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 lead by peers delivered remotely Intervention components: E+MT+AB+EB+SS+P+R
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Setting of implementation: Outpatient care (hospital) Professionals delivering the intervention: Lay person, Nurses Targeted self-management behaviours: Condition-specific behaviours, Eating behaviours, Handling /managing emotions, Self-monitoring

Outcomes measured in the study

Outcome Measure Tool
Adherence to programme Medication adherence N/A
Comorbidities managament Systolic pressure N/A
Quality of life-Physical and psychological functioning Stress Diabetes Distress Scale (DDS)
Quality of life-Physical and psychological functioning Depression Personal Health Questionnaire Depression Scale (PHQ-8)
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 Obesity: N/A Severity of the disease: 37.13 (+/- a standard deviation of 9.31) 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
Adherence to programme - Medication adherence
Comorbidities managament - Systolic pressure
Quality of life-Physical and psychological functioning - Stress
Quality of life-Physical and psychological functioning - Depression
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