Structuring of Diabetes Care in Primary Health Care
Structuring Diabetes Care in Primary Health Care With Individualized Goals and Multidisciplinary Integration: A Cluster-randomized Clinical Trial for
2 other identifiers
interventional
408
1 country
1
Brief Summary
The aim of this study is to evaluate the effectiveness of reorganization in Primary Health Care teams and individualized glycemic targets for type 2 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started May 2023
Typical duration for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2023
CompletedFirst Submitted
Initial submission to the registry
May 2, 2023
CompletedFirst Posted
Study publicly available on registry
May 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedMay 10, 2023
May 1, 2023
2.6 years
May 2, 2023
May 2, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Number of patients who achieved individualized target HbA1c
Number of patients who achieved the individualized target HbA1c defined at baseline
12 months
Secondary Outcomes (2)
Percentage of clinical consultations carried out by nurses
12 months
Foot evaluation
12 months
Study Arms (2)
Intervention
EXPERIMENTALMultimodal intervention in the primary care team that includes: redistribution of diabetes care between nurses and physicians, use of the individualized glycemic target calculator and implementation of minimum care recommendations
Control
ACTIVE COMPARATORUsual follow-up in Primary Health Care (no intervention in the teams)
Interventions
It will be proposed that nurses and physician share the clinical care of patients with type 2 diabetes, with complementing actions
Define the target of individualized glycemic treatment for patients with the support of a tool on the website, which will encourage the intensification and de-intensification of treatment when appropriate
It will be proposed to carry out the minimum necessary assessments that, annually, nurses and physicians must do to ensure the adequacy of quality indicators in the care of diabetes in the PHC
Primary care health teams will follow their rotine care of type 2 diabetes
Eligibility Criteria
You may qualify if:
- Health unit has registered at least 50 users diagnosed with type 2 diabetes
You may not qualify if:
- Health units that do not have a doctor and a nurse available on the same shift or do not have at least one doctor and a nurse willing to participate in the study.
- Individuals:
- Individuals with type 2 diabetes for at least one year
- In person diabetes consultation in the last six months
- Expected survival \< one year
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ana Maria Frölich Matzenbacher
Porto Alegre, Rio Grande do Sul, 90035003, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Beatriz Schaan
UFRGS e HCPA
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2023
First Posted
May 10, 2023
Study Start
May 1, 2023
Primary Completion
December 1, 2025
Study Completion
January 1, 2026
Last Updated
May 10, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share
The data will be available from principal investigator upon reasonable request.