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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Intervention / Treatment: Behavioral: Prochaska and DiClemente transtheorical model

• Study Type: Interventional
• Enrollment (Actual): 174
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Santa Catarina
    • Criciúma, Santa Catarina, Brazil, 88806-000
      • Universidade do Extremo Sul Catarinense
    • Criciúma, Santa Catarina, Brazil, 88806000
      • Universidade do Extremo Sul Catarinense

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic control	Glycemic control as measured by glycated haemoglobin (HbA1c) levels (%)	at 3-monthly intervals during 18 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure control	Blood Pressure control as measured by office systolic and diastolic blood pressure (SBP/DBP in mmHg)	at 6-monthly intervals during 18 month
All-cause number of health care settings visits	All-cause number of health care settings visits measured by counts	at 6-monthly intervals during 18 month
Attributable number of health care settings visits to type 2 diabetes mellitus	Attributable number of health care settings visits to type 2 diabetes mellitus measured by counts	at 6-monthly intervals during 18 month
Weight	Anthropometric variables measured in kg	at 6-monthly intervals during 18 month
Height	Anthropometric variables -measured in meters	at 6-monthly intervals during 18 month
Body mass index	Anthropometric variables - kg per square meter	at 6-monthly intervals during 18 month
Abdominal circumference	Anthropometric variables - measured in centimeters (cm)	at 6-monthly intervals during 18 month
Physical activity levels - Guidelines for Data Processing and Analysis of the International Physical Activity Questionnaire (IPAQ) - Short Form	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	at 6-monthly intervals during 18 month
Depression scores by Hamilton Depression Rating Scale - HDR-S	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.	at 6-monthly intervals during 18 month
Anxiety scores - Hamilton Anxiety Rating Scale (HAM-A)	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.	at 6-monthly intervals during 18 month
MARKERS OF FOOD CONSUMPTION - Food and nutrition surveillance system - Brazil	Qualitative assessment of food intake for the previous day.	at 6-monthly intervals during 18 month
Number of hypoglycemiants, anti-hypertensives and hypolipidemic drugs	Count of hypoglycemiants, anti-hypertensives and hypolipidemic drugs taken by patients	at 6-monthly intervals during 18 month
Low density lipoprotein levels - LDL-C	Serum LDL-C levels in mg/dL	at 3-monthly intervals during 18 month
High density lipoprotein levels - HDL-C	Serum HDL-C levels in mg/dL	at 3-monthly intervals during 18 month
Total cholesterol levels - TC	Serum TC levels in mg/dL	at 3-monthly intervals during 18 month
Total triglycerides levels - TG	Serum TG levels in mg/dL	at 3-monthly intervals during 18 month
Creatinine levels	Serum creatinine levels in mg/dL	at 3-monthly intervals during 18 month
Diabetes Mellitus knowledge (DKN-A)	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	at 6-monthly intervals during 18 month
Diabetes Attitude Questionnaire (ATT-19)	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.	at 6-monthly intervals during 18 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	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.	at 6-monthly intervals during 18 month

Collaborators and Investigators

• Sponsor: Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
• Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico; Hospital Universitário São José; Prefeitura Municipal de Criciúma; Departamento de Promoção da Saúde (DEPROS), Secretaria de Atenção Primária à Saúde (SAPS)
• Investigators: Principal Investigator: Luciane B Ceretta, PhD, Universidade do Extremo Sul Catarinense, The D-CARE Coordinator Committee; Study Chair: Cristiane D Tomasi, PhD, Universidade do Extremo Sul Catarinense, The D-CARE Coordinator/Steering Committee; Study Director: 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 record dates

Study Major Dates

• Study Start (Actual): January 15, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): May 7, 2024

Study Registration Dates

• First Submitted: July 10, 2023
• First Submitted That Met QC Criteria: July 21, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 27, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Cardiovascular Disease; Behavior; Type 2 Diabetes Mellitus; Self Management
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Cardiovascular Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 5.011.600

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will work under individual participant data sharing policy in this study. Third parties interest in should contact the D-CARE Study staff. The IPD Data Sharing Statement is disclosed clearly to patients in our informed consent and also was approved by the responsible IRB. The data will be shared in a deidentified manner, altogether with dictionaries, glossaries, statistical/analytic codes and materials. Authors should provide a proposal that should include the merit, objectives, ethical duties and a data safety plan. For further details please contact the IPD data-sharing committee of the D-CARE Study.
• IPD Sharing Time Frame: After 6 months after the release of the main report of the study up with no constraints in the upper limit.
• IPD Sharing Access Criteria: Under the auspicious of the IPD and steering committee of the D-CARE Study.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No