NCT05969015

Intensive Self-care on Glycemic Control in Outpatients With Type 2 Diabetes Mellitus: The Diabetes Care (D-CARE) Study

Educação em saúde Intensiva na atenção primária à saúde em Pacientes Com Diabetes Mellitus Tipo 2: um Ensaio clínico Randomizado - The Diabetes Care (D-CARE) Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 174 (actual)
• Sponsor: Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Type 2 diabetes mellitus (T2DM) leads to a high burden of morbidity and mortality, usually attributable to cardiovascular (CVD) causes. A major concern about the disease is that the success of the treatment is highly dependent on self-management, which very often incurs the necessity of behavior change. However, modifying such behaviors, usually linked to daily-life activities, is challenging. Then, the investigators aimed to test the optimal self-management that could be achieved in a reasonable manner carried forward through the Prochaska and DiClemente behavior-changing strategy in a follow-up of 18 months, compared to usual care. Our primary outcome is the between-group difference in HbA1c (%) levels.

Conditions

• Diabetes Mellitus, Type 2
• Cardiovascular Diseases
• Diabetes Mellitus

Interventions

Type	Name	Description
BEHAVIORAL	Prochaska and DiClemente transtheorical model	The Prochaska and DiClemente model will be combined to a self-management program in patients with T2DM within 18 months. They will be classified accordingly to their readiness for changing. A care provider will manage the group towards an optimal self-management, aiming to improve their glycemic control and other outcomes of relevance. We will conduct 1 session per week until the end of 12nd intervention month. After, the sections will be conducted each 2 weeks until the end of the trial. Healthcare professional will provide support to the care provider. The recommended processes to progress the patients will be used to trigger them accordingly to their stage, at the discretion of the care provider. We will also consider individualities and non-anticipated problems as a part of the process of behavior changing.

Timeline

• Start date: 2022-01-15
• Primary completion: 2023-12-31
• Completion: 2024-05-07
• First posted: 2023-08-01
• Last updated: 2024-05-29

Locations

2 sites across 1 country: Brazil