Comprehensive Care Protocol in New Diagnosis of Type 2 Diabetes Mellitus and Associated Comorbidities in Primary Care
PICDM2
1 other identifier
interventional
123
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable type-2-diabetes
Started Sep 2019
Typical duration for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2019
CompletedFirst Posted
Study publicly available on registry
June 19, 2019
CompletedStudy Start
First participant enrolled
September 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2021
CompletedFebruary 10, 2021
February 1, 2021
2.1 years
June 13, 2019
February 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change is being assessed in Health Related Quality of Life will be measured through the EuroQoL (EQ-5D)
The EQ-5D health questionnaire provides a simple descriptive profile and a single index value for health status.
The outcome measure will be measured before, up to 3,6 and 12 months to assess its change
HbA1c
Glycosylated hemoglobin for having a clinical response.
up to 12 months.
Change is being assessed in Weigh
Weigh for having a clinical response.
The outcome measure will be measured before, up to 3,6 and 12 months to assess its change
Secondary Outcomes (3)
Dietary habits: PREDIMED
baseline, up to 3,6 and 12 months.
Physical activity: IPAQ
baseline, up to 3,6 and 12 months.
Use of services in the last year
Measure the year after diagnosis in both groups
Study Arms (2)
Intervention
EXPERIMENTALGroup 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
comparison group
NO INTERVENTIONParticipants in the study that do not receive the intervention. usual care.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institut català de la salut
Barcelona, 08006, Spain
Related Publications (1)
Lapena C, Borras E, Digon C, Aznar R, Del Val Garcia JL, Castelblanco E, Garaikoetxea A, Laguna V. Effectiveness of a comprehensive care protocol in patients with new diagnoses of type 2 diabetes mellitus and associated comorbidities in primary care: study protocol of a quasi-experimental trial. BMJ Open. 2020 Jun 23;10(6):e033725. doi: 10.1136/bmjopen-2019-033725.
PMID: 32580980DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2019
First Posted
June 19, 2019
Study Start
September 1, 2019
Primary Completion
September 30, 2021
Study Completion
September 30, 2021
Last Updated
February 10, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
The derived data supporting the findings of this study will be available from the corresponding author \[CL\] on request.