Clinical trial NCT02663245: INTEGRA Study: Primary Care Intervention in Type 2 Diabetes Patients With Poor Glycaemic Control
Official title: INTEGRA Study: Intervention in Type 2 Diabetes Mellitus Patients With Poor Glycemic Control on Primary Health Care.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes mellitus
glycemic control
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2016-01-26
Enrollment: 564
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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


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.

Primary outcomes:
measure: Glycaemic control measured by HbA1c
timeFrame: 12 months
Secondary outcomes:
measure: lipid profile control as measured by the mean concentration of LDL-cholesterol, non-HDL cholesterol and triglycerides
timeFrame: 12 months
measure: measurement of systolic blood pressure and of diastolic blood pressure
timeFrame: 12 months
measure: control of chronic complications associated with type 2 diabetes according to the protocol of the CIH
timeFrame: 12 months
measure: direct health costs of type 2 diabetic patients
timeFrame: 12 months
measure: evaluation of patient satisfaction using spanish version of diabetes treatment satisfaction questionnaire (DTSQ)
timeFrame: 12 months
measure: control of risk factors, smoking and exercise: Patient Activation Measure questionnaire
timeFrame: 12 months
measure: evaluation of therapeutic inertia: specific questionnaire created by Redgedaps
timeFrame: 12 months
measure: evaluation of quality of life using spanish version of diabetes quality of life questionnaire (EsDQOL)
timeFrame: 12 months
Other outcomes:
Locations:
city: Tàrrega
country: Spain
facility: Laura Montero
state: LLeida
Study officials:
affiliation: Institut Català de la Salut
name: Àngels Molló, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Germans Trias i Pujol Hospital
name: Dídac Mauricio, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.