INTEGRA Study: Primary Care Intervention in Type 2 Diabetes Patients With Poor Glycaemic Control

Type 2 Diabetes Mellitus Clinical Trial

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

Status Completed

Clinical Trial Summary

The intensification of the management for the control of glycaemia and other risk factors in patients with type 2 diabetes (DM2) results in a reduction of diabetes-related complications.

The strategy to increase the competences of primary care professionals to improve health care has been mainly prompted by the current context of limited resources and restricted access to specialty care.

This study aims to evaluate the effectiveness and cost-effectiveness of an integral intervention carried out by primary care professionals with the following components:

1. detection of patients with poor diabetic control;

2. introduction of a specific consultation on diabetes followed by virtual and telephone specialist support;

3. introduction of other measures to overcome patients and professionals barriers to treatment.

The main objective of the study is to determine if glycaemic control as measured by the mean concentration of HbA1c of poorly controlled patients improves when these patients are evaluated and treated in primary care under the integral strategy proposed in this study. The INTEGRA project also includes Phase 1 (qualitative research study), which is aimed at identifying viable strategies to suppress barriers to treatment; these strategies have been included to the intervention study (phase 2).

Phase 2 is a controlled, quasi-experimental intervention that involves 9 primary care centres of 3 regions (Lleida, Girona, Barcelona). The participants are patients with DM2 with poor glycaemic control that meet all the inclusion criteria and sign the informed consent. The intervention study will have three arms: (1) Control Group; (2) Intervention Group 1 (diabetes specific consultation + additional measures originated in phase 1; and (3) Intervention Group 2 (additional measures originated in phase 1).

Phase 1 has been conducted during the last 6 months previous to the initiation of the proposed intervention study and consisted of a qualitative design (individualized interviews with randomly selected patients in each of the participating centers); this qualitative study has contributed to design the final intervention applied on phase 2, particularly, implementing additional measures as coaching sessions to health professionals of the participating centers and automated messaging to patients with reminder and motivational objectives.

Phase 2 consists of a recruitment period of 6 months, followed by a 12-month follow-up for each patient

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

• NCT number: NCT02663245
• Study type: Interventional
• Source: Jordi Gol i Gurina Foundation
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Completion date: December 31, 2018