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

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

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Other: Intervention 1; Other: Intervention 2

• Study Type: Interventional
• Enrollment (Actual): 564
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • LLeida
    • Tàrrega, LLeida, Spain, 25300
      • Laura Montero

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Diagnosis of Type 2 DM according to criteria of the World Health Organisation of one or more years of disease duration.
• Age from 30 to 80 years.
• HbA1C ≥ 9% (DCCT) according to the last blood test carried out during the 12 months prior to inclusion in the study
• No changes in the treatment that can influence the main variable during the 3 months prior inclusion in the study.
• Accepting to participate in the study and signing of the informed consent form.

Exclusion criteria:

• Patient refuses to participate and any other condition that prevents signing the informed consent form.
• Other types of diabetes: Type 1 DM, gestational diabetes and diabetes secondary to other diseases.
• Pharmacological treatments that interfere with carbohydrate metabolism, such as steroids.
• Life expectancy under 2 years.
• Current treatment for cancer other than basocellular or epidermoid skin cancer.
• Severe mental disease and dementia.
• Heart failure Class III or IV (NYHA).
• Renal transplant or current treatment with dialysis.
• Alcohol and drug abuse.
• Pregnancy or intention to get pregnant.
• Breastfeeding.
• Chronic treatment with steroids; treatment with steroids during the 2 months prior inclusion in the study.
• Pharmacological treatment for weight loss during the 2 months prior to inclusion in the - study.
• Treatment with immunosuppressants.
• Haemoglobinopathies and chronic anaemia.
• Body Mass Index > 45 mg/kg2 (1)
• Participation in clinical trials for medicines.
• Patients with conditions that prevent follow up and completion of protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention 1; Diabetes specific consultation + multicomponent intervention aimed at professionals and patients	Other: Intervention 1; Diabetes specific consultation; Basic training in clinical guidelines; Platform of communication for professionals; Training update to review and evaluate actual cases where the coaching strategy has been applied 2-hours training programme to update and review the training of month 0.; 7-hour training programme in group coaching for primary care professionals with a theoretical and practical approach.; Intervention based on text messaging to patients to remind them of strategies that promote behaviour change in relation to diabetes.
Experimental: Intervention 2; Multicomponent intervention aimed at professionals and patients minus the diabetes specific consultation.	Other: Intervention 2; 7-hour training programme in group coaching for primary care professionals with a theoretical and practical approach.; Training update to review and evaluate actual cases where the coaching strategy has been applied 2-hour training programme to update and review the training of month 0.; Basic training in clinical guidelines.; Platform of communication for professionals.; Intervention based on text messaging to patients to remind them of strategies that promote behaviour change in relation to diabetes.
No Intervention: Control group; No intervention. Data of the control groups will be retrieved from the SIDIAP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Glycaemic control measured by HbA1c	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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
evaluation of patient satisfaction using spanish version of diabetes treatment satisfaction questionnaire (DTSQ)	12 months
control of risk factors, smoking and exercise: Patient Activation Measure questionnaire	12 months
evaluation of therapeutic inertia: specific questionnaire created by Redgedaps	12 months
evaluation of quality of life using spanish version of diabetes quality of life questionnaire (EsDQOL)	12 months

Collaborators and Investigators

• Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Collaborators: Sanofi
• Investigators: Principal Investigator: Àngels Molló, MD, Institut Català de la Salut; Principal Investigator: Dídac Mauricio, MD, PhD, Germans Trias I Pujol Hospital

Publications and helpful links

General Publications

• Mollo A, Berenguera A, Rubinat E, Vlacho B, Mata M, Franch J, Bolibar B, Mauricio D. INTEGRA study protocol: primary care intervention in type 2 diabetes patients with poor glycaemic control. BMC Fam Pract. 2019 Feb 7;20(1):25. doi: 10.1186/s12875-019-0916-9.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): October 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: December 4, 2015
• First Submitted That Met QC Criteria: January 25, 2016
• First Posted (Estimate): January 26, 2016

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 12, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Type 2 diabetes mellitus; glycemic control
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: P14/129