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Clinical Trial Summary

The purpose of this study is to assess the effectiveness and the cost-effectiveness of the Initial Medication Adherence (IMA) Intervention.


Clinical Trial Description

A pragmatic cluster randomised control trial will be conducted to evaluate the effectiveness of the IMA intervention in comparison to usual care, in the increase of initiation of medicines for CVD and diabetes (antihypertensive, lipid-lowering, antidiabetic and antiplatelet medications) prescribed in Primary Care (PC). The impact of the IMA intervention on secondary adherence and clinical indicators will be evaluated. A multicenter pragmatic RCT, with cluster allocation and 2 parallel branches (IMA intervention vs. usual care) based on health records or RWD will be conducted. PC centres' personnel, including general practitioners (GP), nurses and community pharmacists, from different areas around Catalonia (Spain), will be cluster randomised 1:1 into intervention and control groups, stratified according to the type of PC centre, either rural or urban and taking into consideration the size and localization of the PC centre and the main predictors of non-initiation (socioeconomic status, mean age, % immigrant population of the PC centre). The IMA intervention will provide clinicians with knowledge, skills and tools to help the patient make an informed decision. PC centre personnel in the intervention group will receive training on medication non-initiation, communication abilities, health literacy, shared decision making and the use of support tools such as leaflets and the IMA website. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05026775
Study type Interventional
Source Fundació Sant Joan de Déu
Contact Maria Rubio-Valera, PhD
Phone 93 640 63 50
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date January 2022
Completion date December 2022

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