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

NCT ID: NCT05969015

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-15
• Study Completion Date: 2024-05-07

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Behavior-changing/Self-Management

This arm is composed by group-based interventions aiming to modify the self-management of the patients through the Prochaska and DiClemente transtheorical model. It is composed by weekly meetings, lasting up to 1 hour and a half, targeting eight patients per group. After the 12nd month of intervention, the meetings will be held each fifteen days untill the trial ending (18 months). The meetings will deal with lifestyle matters, such as nutrition, weight management, and physical activity, as well as medication adherence, blood glucose testing, and others. Whenever a care provider will be assigned to a group, he/she will go over untill the final of the trial, unless unexpected motivations appear. Patients achieving maintenance will receive green flag from the group-based interventions to avoid contamination. It is up to the care provider to perceive the readiness of the patient to another stage.

Group Type: EXPERIMENTAL

Prochaska and DiClemente transtheorical model

Intervention Type: BEHAVIORAL

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.

Usual Care

Patients randomized to the usual care group will follow the same schedule of the experimental group for outcome assessment; however, the trial team will not intervene in the group - i.e., the group will continue their care routine in their primary care unit.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Outpatients diagnosed with type 2 diabetes mellitus - T2DM (HbA1c % - ≥ 6.5%, or taking at least one oral hypoglycaemic agent, or medical diagnosis);
• To be regularly assisted by the Sistema Único de Saúde and to have been saw at least one year before randomization;
• Readiness for behavior-changing within the pre-action stages: pre-contemplation, contemplation and preparation;
• T2DM patient of challenging handling (e.g., frequent hypoglycaemic seizures, cardiovascular disease (CVD), etc.);

Exclusion Criteria

• Pregnant women;
• People living with HIV/AIDS;
• T2DM patients taking erythropoietin, recent blood loss, recent blood transfusion and severe anaemia;
• T2DM patients with CVD under non-optimized treatment; or those that made any CVD procedure; or CVD event (e.g., myocardial infarction) within three months before randomization;
• T2DM patients with severe eye and retine disease;
• Patients participating in another study simultaneously;
• Patients living with others in the same place.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prefeitura Municipal de Criciúma

UNKNOWN

Sponsor Role: collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

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

UNKNOWN

Sponsor Role: collaborator

Hospital Universitário São José

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luciane B Ceretta, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade do Extremo Sul Catarinense, The D-CARE Coordinator Committee

Cristiane D Tomasi, PhD

Role: STUDY_CHAIR

Universidade do Extremo Sul Catarinense, The D-CARE Coordinator/Steering Committee

Vanessa IA Miranda, PhD

Role: STUDY_DIRECTOR

Universidade do Extremo Sul Catarinense, The D-CARE Coordinator/Steering Committee

Andriele Vieira, PhD

Role: STUDY_DIRECTOR

The D-CARE Steering Committee

Felipe Dal-Pizzol, MD, PhD

Role: STUDY_DIRECTOR

Universidade do Extremo Sul Catarinense, The D-CARE Adjudication/Medical Committee

Locations

Universidade do Extremo Sul Catarinense

Criciúma, Santa Catarina, Brazil

Universidade do Extremo Sul Catarinense

Criciúma, Santa Catarina, Brazil

Countries

Brazil

Other Identifiers

5.011.600

Identifier Type: -

Identifier Source: org_study_id