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

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

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.

Sponsors & Collaborators

• Prefeitura Municipal de Criciúma

  collaborator UNKNOWN

• Conselho Nacional de Desenvolvimento Científico e Tecnológico

  collaborator OTHER_GOV

• Departamento de Promoção da Saúde (DEPROS), Secretaria de Atenção Primária à Saúde (SAPS)

  collaborator UNKNOWN

• Hospital Universitário São José

  collaborator OTHER

• Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude

  lead OTHER

Principal Investigators

• Luciane B Ceretta, PhD · Universidade do Extremo Sul Catarinense, The D-CARE Coordinator Committee

• Cristiane D Tomasi, PhD · Universidade do Extremo Sul Catarinense, The D-CARE Coordinator/Steering Committee

• Vanessa IA Miranda, PhD · Universidade do Extremo Sul Catarinense, The D-CARE Coordinator/Steering Committee

• Andriele Vieira, PhD · The D-CARE Steering Committee

• Felipe Dal-Pizzol, MD, PhD · Universidade do Extremo Sul Catarinense, The D-CARE Adjudication/Medical Committee

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-15

Primary Completion

2023-12-31

Completion

2024-05-07

Countries

• Brazil

Study Locations