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

Sponsor

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

Overall Status

Recruiting

CT.gov ID

NCT05969015

Collaborator

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

384

Enrollment

Locations

Arms

23.5

Anticipated Duration (Months)

192

Patients Per Site

8.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2 Cardiovascular Diseases Diabetes Mellitus	Behavioral: Prochaska and DiClemente transtheorical model	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

384 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Single (Outcomes Assessor)

Masking Description:

Outcomes' assessors will be masked to assigned interventions in all measurements they would perform.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 15, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Glycemic control [at 3-monthly intervals during 18 month]
Glycemic control as measured by glycated haemoglobin (HbA1c) levels (%)

Secondary Outcome Measures

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

Adverse Events [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidade do Extremo Sul Catarinense	Criciúma	Santa Catarina	Brazil	88806-000
2	Universidade do Extremo Sul Catarinense	Criciúma	Santa Catarina	Brazil	88806000

Sponsors and Collaborators

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

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