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

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Other: Intervention 2; Other: Intervention 1

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02663245

P14/129

Details and patient eligibility

About

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

Enrollment: 564 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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564 participants in 3 patient groups

Intervention 1

Experimental group

Description:

Diabetes specific consultation + multicomponent intervention aimed at professionals and patients

Treatment:

Other: Intervention 1

Intervention 2

Experimental group

Description:

Multicomponent intervention aimed at professionals and patients minus the diabetes specific consultation.

Treatment:

Other: Intervention 2

Control group

No Intervention group

Description:

No intervention. Data of the control groups will be retrieved from the SIDIAP.