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

NCT05969015 | Completed DMC

• 1 other identifier: 5.011.600
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 2

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

Keywords

Self Management; Behavior; Type 2 Diabetes Mellitus; Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• Glycemic control

  Glycemic control as measured by glycated haemoglobin (HbA1c) levels (%)

  at 3-monthly intervals during 18 month

Secondary Outcomes (19)

• Blood Pressure control

  at 6-monthly intervals during 18 month

• All-cause number of health care settings visits

  at 6-monthly intervals during 18 month

• Attributable number of health care settings visits to type 2 diabetes mellitus

  at 6-monthly intervals during 18 month

• Weight

  at 6-monthly intervals during 18 month

• Height

  at 6-monthly intervals during 18 month

Other Outcomes (1)

• Adverse Events

  at 6-monthly intervals during 18 month

Study Arms (2)

Behavior-changing/Self-Management

EXPERIMENTAL

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.

Behavioral: Prochaska and DiClemente transtheorical model

Usual Care

NO INTERVENTION

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.

Interventions

Prochaska and DiClemente transtheorical model 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.

Behavior-changing/Self-Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude: lead
• Prefeitura Municipal de Criciúma: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Departamento de Promoção da Saúde (DEPROS), Secretaria de Atenção Primária à Saúde (SAPS): collaborator
• Hospital Universitário São José: collaborator

Study Sites (2)

Universidade do Extremo Sul Catarinense

Criciúma, Santa Catarina, 88806-000, Brazil

Location

Universidade do Extremo Sul Catarinense

Criciúma, Santa Catarina, 88806000, Brazil

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases; Diabetes Mellitus; Behavior

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Luciane B Ceretta, PhD

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

  PRINCIPAL INVESTIGATOR

• Cristiane D Tomasi, PhD

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

  STUDY CHAIR

• Vanessa IA Miranda, PhD

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

  STUDY DIRECTOR

• Andriele Vieira, PhD

  The D-CARE Steering Committee

  STUDY DIRECTOR

• Felipe Dal-Pizzol, MD, PhD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes' assessors will be masked to assigned interventions in all measurements they would perform.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an effectiveness/pragmatic, parallel-arm, randomized, superiority trial.

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: August 1, 2023
• Study Start: January 15, 2022
• Primary Completion: December 31, 2023
• Study Completion: May 7, 2024
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: After 6 months after the release of the main report of the study up with no constraints in the upper limit.
• Access Criteria: Under the auspicious of the IPD and steering committee of the D-CARE Study.

Locations

BR (2)