Evidence map›Paper›PMID 30732583›Full record

ArticleBMC family practice2019

INTEGRA study protocol: primary care intervention in type 2 diabetes patients with poor glycaemic control.

Àngels Molló, Anna Berenguera, Esther Rubinat, Bogdan Vlacho, Manel Mata, Josep Franch, Bonaventura Bolíbar, Dídac Mauricio

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC family practice, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02663245 (INTEGRA Study), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 33% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02663245 nacompletednot on this map

INTEGRA Study: Intervention in Type 2 Diabetes Mellitus Patients With Poor Glycemic Control on Primary Health Care.

TypeinterventionalSponsorFundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaRan2015 to 2018Enrolled564ConditionsType 2 Diabetes MellitusArmsIntervention 1, Intervention 2
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 4 institutions in 1 country.

Àngels MollóCentre d'Atenció Primària de Cervera, Lleida, Spain.
Anna BerengueraInstitut Universitari d'Investigació en Atenció Primària Jordi Gol, Barcelona, Spain.
Esther RubinatInstitut Universitari d'Investigació en Atenció Primària Jordi Gol, Barcelona, Spain.
Bogdan VlachoInstitut Universitari d'Investigació en Atenció Primària Jordi Gol, Gran Via Corts Catalanes, 587, àtic, 08007, Barcelona, Spain.
Manel MataCentre d'Atenció Primària La Mina, Barcelona, Spain.
Josep FranchCentre d'Atenció Primària Raval Sud, CIBER of Diabetes and Associated Metabolic Diseases (CIBERDEM), Institut Català de la Salut, Institut Universitari d'Investigacióen Atenció Primària Jordi Gol, Av. Drassanes, 17-21 08001, Barcelona, Spain.
Bonaventura BolíbarInstitut Universitari d'Investigacióen Atenció Primària Jordi Gol, Barcelona, Spain.
Dídac MauricioDepartment of Endocrinology & Nutrition, CIBER of Diabetes and Associated Metabolic Diseases (CIBERDEM), Health Sciences Research Institute and University Hospital de la Santa Creu i Sant Pau, Barcelona, Spain. didacmauricio@gmail.com.
Centro de Investigación Biomédica en Red Diabetes y Enfermedades Metabólicas Asociadas · ESInstitut Universitari d'Investigació en Atenció Primària Jordi Gol · ESCentre for Demographic Studies · ESUniversitat Autònoma de Barcelona · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe management of hyperglycaemia and associated cardiovascular risk factors in patients with type 2 diabetes mellitus (T2DM) may reduce diabetes-related complications. The strategy to broaden the knowledge base of primary care professionals to improve health care has mainly been prompted by the current reality of limited resources and access to specialized care. The main objective of this study is to assess the effectiveness of comprehensive interventions focused on treatment intensification, decrease clinical inertia and reduce possible barriers to treatment adherence in patients with poorly controlled diabetes in a primary care setting.

methodsThis is a two-phase mixed method study, whose aims are the development of complex interventions and the assessment of their effectiveness. The main study outcome is a change in glycated haemoglobin (HbA1c) levels. The INTEGRA study is divided into two phases. Phase 1: A qualitative study with a phenomenological approach using semi-structured interviews with the objective of determining the factors related to the participants and health care professionals that influence the development and implementation of a specific intervention strategy aimed at patients with poor glycaemic control of T2DM in primary care. Phase 2: Exploratory intervention study to be conducted in Primary Health Care Centres in Catalonia (Spain), including 3 specific health care areas. The intervention study has two arms: Intervention Group 1 and 2. Each intervention group will recruit 216 participants (the same as in the control group) between the ages of 30 and 80 years with deficient glycaemic control (HbA1c > 9%). The control group will be established based on a randomized selection from the large SIDIAP (Sistema d'Informació per al desenvolupament de la Investigació en Atenció Primària) database of patients with comparable socio-demographic and clinical characteristics from the three provinces. DISCUSSION: This study is a comprehensive, pragmatic intervention based on glycaemic treatment intensification and the control of other cardiovascular risk factors. It is also aimed at improving treatment adherence and reducing clinical inertia, which could lead to improved glycaemic control and could likewise be feasible for implementation in the actual clinical practice of primary care.

trial registrationClinicaltrials.gov . registration number. NCT02663245; January 25, 2016.

Indexed as

Diabetes Mellitus, Type 2Hypoglycemic AgentsMedication AdherencePrimary Health CareSelf EfficacyGlycated HemoglobinHumansPragmatic Clinical Trials as TopicQualitative ResearchGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsClinical inertiaGlycated haemoglobinInterventionPrimary careTreatment intensificationType 2 diabetes

Identifiers

PMID30732583
PMCPMC6367799
OpenAlexW2919318523

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.