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

NCT ID: NCT02663245

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 564 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2018-12-31

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

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention 1

Diabetes specific consultation + multicomponent intervention aimed at professionals and patients

Group Type: EXPERIMENTAL

Intervention 1

Intervention Type: OTHER

• 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.

Intervention 2

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

Group Type: EXPERIMENTAL

Intervention 2

Intervention Type: OTHER

• 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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role: lead

Responsible Party

Àngels Molló

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Àngels Molló, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Català de la Salut

Dídac Mauricio, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Germans Trias i Pujol Hospital

Locations

Laura Montero

Tàrrega, LLeida, Spain

Countries

Spain

References

Mollo A, Vlacho B, Gratacos M, Mata-Cases M, Rubinat E, Berenguera Osso A, Cos FX, Franch-Nadal J, Khunti K, Mauricio D; INTEGRA research group. A multicomponent health care intervention is associated with improved glycaemic control in subjects with poorly controlled type 2 diabetes compared with routine care: The INTEGRA study. Diabetes Obes Metab. 2023 Dec;25(12):3549-3559. doi: 10.1111/dom.15250. Epub 2023 Aug 22.

Reference Type: DERIVED

PMID: 37608473 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30732583 (View on PubMed)

Other Identifiers

P14/129

Identifier Type: -

Identifier Source: org_study_id