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

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

Status: Completed

Conditions: Diabetes Mellitus; Cardiovascular Diseases; Diabetes Mellitus, Type 2

Treatments: Behavioral: Prochaska and DiClemente transtheorical model

Study type: Interventional

Funder types: Other

Identifiers

NCT05969015

5.011.600

Details and patient eligibility

About

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.

Enrollment: 174 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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174 participants in 2 patient groups

Behavior-changing/Self-Management

Experimental group

Description:

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.

Treatment:

Behavioral: Prochaska and DiClemente transtheorical model

Usual Care

No Intervention group

Description:

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.