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Completed

NCT Number: NCT05969015

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Behavior Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade do Extremo Sul Catarinense, Criciúma, Santa Catarina, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Glycemic control

    Time frame: at 3-monthly intervals during 18 month

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

Secondary outcomes

  1. Blood Pressure control

    Time frame: at 6-monthly intervals during 18 month

    Blood Pressure control as measured by office systolic and diastolic blood pressure (SBP/DBP in mmHg)

  2. All-cause number of health care settings visits

    Time frame: at 6-monthly intervals during 18 month

    All-cause number of health care settings visits measured by counts

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

    Time frame: at 6-monthly intervals during 18 month

    Attributable number of health care settings visits to type 2 diabetes mellitus measured by counts

  4. Weight

    Time frame: at 6-monthly intervals during 18 month

    Anthropometric variables measured in kg

  5. Height

    Time frame: at 6-monthly intervals during 18 month

    Anthropometric variables -measured in meters

  6. Body mass index

    Time frame: at 6-monthly intervals during 18 month

    Anthropometric variables - kg per square meter

  7. Abdominal circumference

    Time frame: at 6-monthly intervals during 18 month

    Anthropometric variables - measured in centimeters (cm)

  8. Physical activity levels - Guidelines for Data Processing and Analysis of the International Physical Activity Questionnaire (IPAQ) - Short Form

    Time frame: at 6-monthly intervals during 18 month

    There are three levels of physical activity suggested for classifying populations; these are the new proposed levels, which take account of the concept of total physical activity of all domains. The proposed levels are: inactive; minimally active and HEPA activeí health-enhancing physical activity; a highly active category

  9. Depression scores by Hamilton Depression Rating Scale - HDR-S

    Time frame: at 6-monthly intervals during 18 month

    A score of 0-7 is generally accepted to be within the normal range (or in clinical emission), while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial.

  10. Anxiety scores - Hamilton Anxiety Rating Scale (HAM-A)

    Time frame: at 6-monthly intervals during 18 month

    Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.

  11. MARKERS OF FOOD CONSUMPTION - Food and nutrition surveillance system - Brazil

    Time frame: at 6-monthly intervals during 18 month

    Qualitative assessment of food intake for the previous day.

  12. Number of hypoglycemiants, anti-hypertensives and hypolipidemic drugs

    Time frame: at 6-monthly intervals during 18 month

    Count of hypoglycemiants, anti-hypertensives and hypolipidemic drugs taken by patients

  13. Low density lipoprotein levels - LDL-C

    Time frame: at 3-monthly intervals during 18 month

    Serum LDL-C levels in mg/dL

  14. High density lipoprotein levels - HDL-C

    Time frame: at 3-monthly intervals during 18 month

    Serum HDL-C levels in mg/dL

  15. Total cholesterol levels - TC

    Time frame: at 3-monthly intervals during 18 month

    Serum TC levels in mg/dL

  16. Total triglycerides levels - TG

    Time frame: at 3-monthly intervals during 18 month

    Serum TG levels in mg/dL

  17. Creatinine levels

    Time frame: at 3-monthly intervals during 18 month

    Serum creatinine levels in mg/dL

  18. Diabetes Mellitus knowledge (DKN-A)

    Time frame: at 6-monthly intervals during 18 month

    The measuring scale used is from 0 to 15. A score of one (1) is attributed to the correct answer and of zero (0) for the incorrect answer. A score higher than eight (8) indicates knowledge about diabetes mellitus

  19. Diabetes Attitude Questionnaire (ATT-19)

    Time frame: at 6-monthly intervals during 18 month

    ATT-19 is an instrument that seeks to measure psychological adjustment for diabetes mellitus, developed in response to the need for evaluation of the psychological and emotional aspects of the disease. It contains nineteen items that include six factors: a) DM-associated stress, b) treatment receptivity, c) trust in the treatment, d) personal efficiency, e) health perception, and f) social acceptance, with the answers measured using a five-point Likert scale (completely disagree - score 1; up to completely agree - score 5). The total value of the score can vary from 19 to 95 points. A score higher than 70 indicates a positive attitude toward the disease. In this instrument, attitude is related to the decision of the individual to adopt or not the self-care measures for diabetes control.

Other outcomes

  1. Adverse Events

    Time frame: at 6-monthly intervals during 18 month

    Adverse Events as counts: all-cause mortality, cardiovascular mortality, STEMI and non-STEMI (fatal and non-fatal), heart failure diagnosis, unstable angina hospitalizations, cardiovascular procedures, hospital admission or re-admission, chronic kidney disease, retinopathy diagnosis, falls.

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Departamento de Promoção da Saúde (DEPROS), Secretaria de Atenção Primária à Saúde (SAPS)
  • Hospital Universitário São José
  • Prefeitura Municipal de Criciúma

Registry information

Official study title

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

Acronym: D-CARE

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Aug 1, 2023
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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