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

NCT02663245 | Completed

• 1 other identifier: P14/129
• Study Type: interventional
• Target: 564
• Locations: 1 country
• Sites: 1

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. 1.detection of patients with poor diabetic control;
2. 2.introduction of a specific consultation on diabetes followed by virtual and telephone specialist support;
3. 3.introduction of other measures to overcome patients and professionals barriers to treatment.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes mellitus; glycemic control

Outcome Measures

Primary Outcomes (1)

• Glycaemic control measured by HbA1c

  12 months

Secondary Outcomes (8)

• 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

Study Arms (3)

Intervention 1

EXPERIMENTAL

Diabetes specific consultation + multicomponent intervention aimed at professionals and patients

Other: Intervention 1

Intervention 2

EXPERIMENTAL

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

Other: Intervention 2

Control group

NO INTERVENTION

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

Interventions

Intervention 1 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 1

Intervention 2 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.

Intervention 2

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Accepting to participate in the study and signing of the informed consent form.

You may not qualify if:

• 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.
• Treatment with immunosuppressants.
• Haemoglobinopathies and chronic anaemia.
• Body Mass Index \> 45 mg/kg2 (1)
• Participation in clinical trials for medicines.

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• Sanofi: collaborator

Study Sites (1)

Laura Montero

Tàrrega, LLeida, 25300, Spain

Location

Related Publications (2)

• 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.

  PMID: 37608473 DERIVED

• 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.

  PMID: 30732583 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Àngels Molló, MD

  Institut Català de la Salut

  PRINCIPAL INVESTIGATOR

• Dídac Mauricio, MD, PhD

  Germans Trias i Pujol Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 4, 2015
• First Posted: January 26, 2016
• Study Start: December 1, 2015
• Primary Completion: October 31, 2018
• Study Completion: December 31, 2018
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

ES (1)