Structuring of Diabetes Care in Primary Health Care

Sponsor
Hospital de Clinicas de Porto Alegre (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05852626
Collaborator
Conselho Nacional de Desenvolvimento Científico e Tecnológico (Other)
408
1
2
32.1
12.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Redistribution of diabetes care between nurses and physicians
  • Other: Individualized glycemic target
  • Other: Minimum care recomendations
  • Other: No intervention
N/A

Detailed Description

The prevalence of diabetes is increasing in parallel with the obesity epidemic. Diabetes is, therefore, a costly disease for individuals and healthcare system, generating expenses in its management and its complications. Also, it has significant social cost related to reduction of productivity. This study will evaluate the effectiveness of a multimodal intervention for Primary Health Care (PHC) teams to increase the nurse clinical role and implement individualized glycemic targets and care plan for type 2 diabetes through a pragmatic cluster-randomized clinical trial, with 1:1 allocation of health units in Porto Alegre, Brazil. Two study arms will be evaluated: 1) intervention group: will receive a set of proposed actions (redistribution of diabetes care between nurses and physicians, use of the individualized glycemic target calculator and implementation of care recommendations); 2) control group: usual follow-up in PHC.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
408 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Cluster randomized clinical trialCluster randomized clinical trial
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Structuring Diabetes Care in Primary Health Care With Individualized Goals and Multidisciplinary Integration: A Cluster-randomized Clinical Trial for
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Jan 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

Multimodal 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

Other: Redistribution of diabetes care between nurses and physicians
It will be proposed that nurses and physician share the clinical care of patients with type 2 diabetes, with complementing actions

Other: Individualized glycemic target
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

Other: Minimum care recomendations
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

Active Comparator: Control

Usual follow-up in Primary Health Care (no intervention in the teams)

Other: No intervention
Primary care health teams will follow their rotine care of type 2 diabetes

Outcome Measures

Primary Outcome Measures

  1. Number of patients who achieved individualized target HbA1c [12 months]

    Number of patients who achieved the individualized target HbA1c defined at baseline

Secondary Outcome Measures

  1. Percentage of clinical consultations carried out by nurses [12 months]

    Proportion of nursing consultations in relation to the total number of consultations (nurse and physician)

  2. Foot evaluation [12 months]

    Total number of nursing consultations in which the feet were evaluated

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Health care unit:

Inclusion criteria

  • Health unit has registered at least 50 users diagnosed with type 2 diabetes
Exclusion criteria:
  • 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:

Inclusion criteria

  • Individuals with type 2 diabetes for at least one year

  • In person diabetes consultation in the last six months

Exclusion criteria:
  • Expected survival < one year

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ana Maria Frölich Matzenbacher Porto Alegre Rio Grande Do Sul Brazil 90035003

Sponsors and Collaborators

  • Hospital de Clinicas de Porto Alegre
  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

  • Principal Investigator: Beatriz Schaan, UFRGS e HCPA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT05852626
Other Study ID Numbers:
  • 20220197
  • 64538322.1.0000.5327
First Posted:
May 10, 2023
Last Update Posted:
May 10, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 10, 2023