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Diabetes Mellitus, Type 2D-CARENCT05969015

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

A study testing Prochaska and DiClemente transtheorical model in people with Diabetes Mellitus, Type 2 and Cardiovascular Diseases, run by Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude at 2 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Prochaska and DiClemente transtheorical model
Could I receive a placebo?
No, everyone receives an active treatment
How many people
174 participants
Where
2 sitesBrazil
Study dates
15 Jan 2022to 7 May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.);

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites

  • Universidade do Extremo Sul Catarinense

    Criciúma, Santa Catarina, 88806-000

  • Universidade do Extremo Sul Catarinense

    Criciúma, Santa Catarina, 88806000

Other trials in Brazil

About this study

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

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.

Being tested
Prochaska and DiClemente transtheorical model
Keywords
Self Management, Behavior, Type 2 Diabetes Mellitus, Cardiovascular Disease
Medical subject headings
Diabetes Mellitus, Type 2, Cardiovascular Diseases, Diabetes Mellitus, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prochaska and DiClemente transtheorical modelBehavioural

    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.

Study groups in NCT05969015
Study groupRoleWhat they receive
Behavior-changing/Self-ManagementExperimentalThis 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.
Receives: Behavioral: Prochaska and DiClemente transtheorical model
Usual CareNo interventionPatients 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Glycemic control

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

    Measured: at 3-monthly intervals during 18 month

Secondary outcomes (19)

  1. Blood Pressure control

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

    Measured: at 6-monthly intervals during 18 month

  2. All-cause number of health care settings visits

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

    Measured: at 6-monthly intervals during 18 month

  3. 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

    Measured: at 6-monthly intervals during 18 month

  4. Weight

    Anthropometric variables measured in kg

    Measured: at 6-monthly intervals during 18 month

  5. Height

    Anthropometric variables -measured in meters

    Measured: at 6-monthly intervals during 18 month

  6. Body mass index

    Anthropometric variables - kg per square meter

    Measured: at 6-monthly intervals during 18 month

  7. Abdominal circumference

    Anthropometric variables - measured in centimeters (cm)

    Measured: at 6-monthly intervals during 18 month

  8. 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

    Measured: at 6-monthly intervals during 18 month

  9. 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.

    Measured: at 6-monthly intervals during 18 month

  10. 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.

    Measured: at 6-monthly intervals during 18 month

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

    Qualitative assessment of food intake for the previous day.

    Measured: at 6-monthly intervals during 18 month

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

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

    Measured: at 6-monthly intervals during 18 month

  13. Low density lipoprotein levels - LDL-C

    Serum LDL-C levels in mg/dL

    Measured: at 3-monthly intervals during 18 month

  14. High density lipoprotein levels - HDL-C

    Serum HDL-C levels in mg/dL

    Measured: at 3-monthly intervals during 18 month

  15. Total cholesterol levels - TC

    Serum TC levels in mg/dL

    Measured: at 3-monthly intervals during 18 month

  16. Total triglycerides levels - TG

    Serum TG levels in mg/dL

    Measured: at 3-monthly intervals during 18 month

  17. Creatinine levels

    Serum creatinine levels in mg/dL

    Measured: at 3-monthly intervals during 18 month

  18. 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

    Measured: at 6-monthly intervals during 18 month

  19. 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.

    Measured: at 6-monthly intervals during 18 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2023
  2. Study start15 Jan 2022
  3. Primary completion31 Dec 2023
  4. Study completion7 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is an effectiveness/pragmatic, parallel-arm, randomized, superiority trial.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
174 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05969015
Sponsor's protocol ID
5.011.600
Acronym
D-CARE
Status last verified
May 2024
First submitted
10 Jul 2023
Last updated
29 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Prochaska and DiClemente transtheorical model in people with Diabetes Mellitus, Type 2 and Cardiovascular Diseases, run by Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude at 2 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycemic control (time frame: at 3-monthly intervals during 18 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05969015.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.

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