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Comprehensive Care Protocol in New Diagnosis of Type 2 Diabetes Mellitus and Associated Comorbidities in Primary Care (PICDM2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03990857
Recruitment Status : Active, not recruiting
First Posted : June 19, 2019
Last Update Posted : February 10, 2021
Sponsor:
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation

Brief Summary:

Introduction

Type 2 Diabetes is a very prevalent chronic disease in our environment. It usually exists with other chronic diseases. Although drug intensification at the time of new diagnosis has proven effective in reduction of cardiovascular and diabetes control and complications, an intensification of comprehensive health education has not been proven so. Currently, there is a great variability in practices of Primary Care nurses in front of the health education in the moment of new diagnosis.

The aim of this study is to evaluate the effectiveness of a systematic protocol with an integrated care in people with newly diagnosed type 2 diabetes (DM2) and associated comorbidities, which included 5 structured individual visits post-diagnosis with the Primary care nurse.

Methods

Quasi-experimental design, comparing a group of individuals taking part in the intervention with a similar group receiving usual care. Data will be collected at the beginning, at the end of the intervention and after 6 and 12 months. 10 primary care centers in the city of Barcelona will be selected on a convenience basis as IG and CG. The subjects of the GC will be monitored as usual. Performed analysis will be the baseline comparability between GI and GC in relationship to different variables as well as the changes in dependent variables along the study; establishing comparisons between GC and GI . The results will be measured in terms of quality of life related to health, development of biological parameters (HbA1c and weight) and compliance with the therapeutic plan.

Discussion

The results of this study will help to 1)demonstrate that by intensifying the hygienic-dietetic measures in the initial stage of DM2 diagnosis, the disease and associated co-morbidities are controlled in a better way. 2) validate a material that allows to decrease the variability in the care offered by primary care nurses to people in this group.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Other: Comprehensive care protocol in new diagnosis of Type 2 Diabetes Mellitus and associated comorbidities in Primary Care Not Applicable

Detailed Description:

Objectives

To evaluate the effectiveness of the systematic application of the comprehensive care protocol in people who debut in DM2 and associated comorbidities, applied during 3 months in primary care, in terms of quality of life related to Health, weigh loss and Glycosylated hemoglobin (HbA1c) compared to people who receive normal practice.

Secondary: To evaluate the effectiveness of the systematic application of the comprehensive care protocol of DM and associated comorbidities, during 3 months in primary care, in the parameters:

  • Evolution of the specific biological parameters: TA, BMI, lipid profile, abdominal perimeter.
  • Evolution of the consumption of drugs.
  • Compliance with dietary recommendations.
  • Increase in physical activity.
  • Satisfaction / opinion of the participants. According to a questionnaire of user satisfaction of the ICS adapted to our study.
  • Health frequentation in Primary Care Centers.

Methods and Analysis Study Design: A quantitative quasi-experimental design, multicenter, one-year follow-up, comparing a group of patients with a recent DM2 debut (less than 5 months) treated according to the comprehensive care protocol in DM2 with comorbidities, the intervention (IG), with a group of similar characteristics who receive the usual care (CG). The response variables will be evaluated before starting the care according to protocol, after (3 months) and at 6 and 12 months of initiating the intervention, in both groups.

Scope of the study: It will be developed in 10 urban primary care health centers, in 5 centers the intervention will be carried out and in 5 the controls will be selected. The allocation of a center as an intervention or comparison will be random. In the calculation of the sample the cluster effect attributable to this design has been considered.

Subjects of the study: The study population will consist of patients attended in the selected Primary Care Centers with a new diagnosis of DM2 (less than 5 months from the debut) that present comorbidity with an other chronic cardiovascular condition (Hypertension, dyslipidemia and/or obesity). Will be excluded COPD and IC, because they are attended with a specific protocol of care.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Comprehensive Care Protocol in New Diagnosis of Type 2 Diabetes Mellitus and Associated Comorbidities in Primary Care: Quasi-experimental Study.
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Group of participants with a recent DM2 debut (less than 5 months) treated according to the comprehensive care protocol in DM2 with comorbidities attended in Primary care nurse office
Other: Comprehensive care protocol in new diagnosis of Type 2 Diabetes Mellitus and associated comorbidities in Primary Care
This comprehensive intervention is developed in a structured way in the Primary care nurse office. 5 individual intensive visits will be carried out with a weekly or bi-weekly frequency (according to the learning process) to work for an integral care and to transmit the knowledge and skills required. The maximum time expected to receive this 5 visits is 3 months. At least one of the visits, preferably the one that deals with dietary aspects, the patient is asked to be visited with the partner, child or cohabiting person. The research team elaborated the support material with the minimum contents that every patient that begins with T2DM and other chronic pathologies should know. It allows incorporating cultural and emotional aspects. It was agreed with hospital diabetes educators and family doctors. A graphic designer gave an enticing design. A group of patients verified their utility and intelligibility. It is delivered to the person and discussed during the intensification.

No Intervention: comparison group
Participants in the study that do not receive the intervention. usual care.



Primary Outcome Measures :
  1. Change is being assessed in Health Related Quality of Life will be measured through the EuroQoL (EQ-5D) [ Time Frame: The outcome measure will be measured before, up to 3,6 and 12 months to assess its change ]
    The EQ-5D health questionnaire provides a simple descriptive profile and a single index value for health status.

  2. HbA1c [ Time Frame: up to 12 months. ]
    Glycosylated hemoglobin for having a clinical response.

  3. Change is being assessed in Weigh [ Time Frame: The outcome measure will be measured before, up to 3,6 and 12 months to assess its change ]
    Weigh for having a clinical response.


Secondary Outcome Measures :
  1. Dietary habits: PREDIMED [ Time Frame: baseline, up to 3,6 and 12 months. ]
    with the Predimed questionnaire. It consists of 14 questions. If the answer corresponds to a healthy practice, 1 point per question is counted. The range of answers goes from 0 (worst result) to 14 (best result).

  2. Physical activity: IPAQ [ Time Frame: baseline, up to 3,6 and 12 months. ]
    with the IPAQ questionnaire. The IPAQ asks about the exercise performed the last 7 days. It is structured to provide walking scores, moderate and high intensity activities. The final score of the short form requires the sum of the duration (in minutes) and frequency (days). The data obtained by the IPAQ can be shown as a continuous variable, for this each activity is measured by its energy requirements defined as MET's and in that way can be expressed in MET's-minute. More METs correspond to more exercise. Higher values represent a better outcome.

  3. Use of services in the last year [ Time Frame: Measure the year after diagnosis in both groups ]
    (Primary Care visits). Number or visits in GP and nurse office and at home during the year of the study.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • People between both sexes between 18 and 80 years old with a recent (less than 5 months)diagnosis of DM 2 + comorbidity , assigned to the nurses that participate in the study and who give their consent to participate.

Exclusion Criteria:

  • People who participate in a similar project.
  • People with difficulty maintaining their participation for 12 months.
  • People who have difficulty understanding and expressing themselves in Catalan or Spanish.
  • People who have serious health problems: serious mental disease, terminal processes.
  • People with COPD and IC, because they were included in another study with a specific care plan.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03990857


Locations
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Spain
Institut català de la salut
Barcelona, Spain, 08006
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT03990857    
Other Study ID Numbers: 4R16/045
First Posted: June 19, 2019    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The derived data supporting the findings of this study will be available from the corresponding author [CL] on request.
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jordi Gol i Gurina Foundation:
comorbidities comprehensive care
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases