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

NCT03990857 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2021-02-10

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2021-09-30
Completion
2021-09-30

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03990857 on ClinicalTrials.gov