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

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Other: Intervention 2; Other: Intervention 1

• Registration Number: NCT02663245
• Lead Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-04
• Study First Submitted QC: 2016-01-25
• Study First Posted: 2016-01-26
• Primary Completion: 2018-10-31
• Study Completion: 2018-12-31
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-12
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 564

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention 2	Intervention 2	Multicomponent intervention aimed at professionals and patients minus the diabetes specific consultation.
Intervention 1	Intervention 1	Diabetes specific consultation + multicomponent intervention aimed at professionals and patients

Primary Outcome Measures

Name	Time	Method
Glycaemic control measured by HbA1c	12 months

Secondary Outcome Measures

Name	Time	Method
evaluation of patient satisfaction using spanish version of diabetes treatment satisfaction questionnaire (DTSQ)	12 months
lipid profile control as measured by the mean concentration of LDL-cholesterol, non-HDL cholesterol and triglycerides	12 months
measurement of systolic blood pressure and of diastolic blood pressure	12 months
evaluation of therapeutic inertia: specific questionnaire created by Redgedaps	12 months
control of chronic complications associated with type 2 diabetes according to the protocol of the CIH	12 months
direct health costs of type 2 diabetic patients	12 months
control of risk factors, smoking and exercise: Patient Activation Measure questionnaire	12 months
evaluation of quality of life using spanish version of diabetes quality of life questionnaire (EsDQOL)	12 months

Trial Locations

Locations (1)

Laura Montero; 🇪🇸 Tàrrega, LLeida, Spain