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

Diabetes Mellitus, Type 2 Clinical Trial

— D-CARE  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05969015
• Other study ID #: 5.011.600
• Status: Completed
• Phase: N/A
• Start date: January 15, 2022
• Est. completion date: May 7, 2024

Study information

• Verified date: May 2024
• Source: Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: May 7, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
Brazil	Universidade do Extremo Sul Catarinense	Criciúma	Santa Catarina
Brazil	Universidade do Extremo Sul Catarinense	Criciúma	Santa Catarina

Sponsors (5)

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

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Glycemic control	Glycemic control as measured by glycated haemoglobin (HbA1c) levels (%)	at 3-monthly intervals during 18 month
Secondary	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
Secondary	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
Secondary	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
Secondary	Weight	Anthropometric variables measured in kg	at 6-monthly intervals during 18 month
Secondary	Height	Anthropometric variables -measured in meters	at 6-monthly intervals during 18 month
Secondary	Body mass index	Anthropometric variables - kg per square meter	at 6-monthly intervals during 18 month
Secondary	Abdominal circumference	Anthropometric variables - measured in centimeters (cm)	at 6-monthly intervals during 18 month
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Low density lipoprotein levels - LDL-C	Serum LDL-C levels in mg/dL	at 3-monthly intervals during 18 month
Secondary	High density lipoprotein levels - HDL-C	Serum HDL-C levels in mg/dL	at 3-monthly intervals during 18 month
Secondary	Total cholesterol levels - TC	Serum TC levels in mg/dL	at 3-monthly intervals during 18 month
Secondary	Total triglycerides levels - TG	Serum TG levels in mg/dL	at 3-monthly intervals during 18 month
Secondary	Creatinine levels	Serum creatinine levels in mg/dL	at 3-monthly intervals during 18 month
Secondary	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
Secondary	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