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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02663245
• Other study ID #: P14/129
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2019
• Source: Jordi Gol i Gurina Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 564
• Est. completion date: December 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Laura Montero	Tàrrega	LLeida

Sponsors (2)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation	Sanofi

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycaemic control measured by HbA1c		12 months
Secondary	lipid profile control as measured by the mean concentration of LDL-cholesterol, non-HDL cholesterol and triglycerides		12 months
Secondary	measurement of systolic blood pressure and of diastolic blood pressure		12 months
Secondary	control of chronic complications associated with type 2 diabetes according to the protocol of the CIH		12 months
Secondary	direct health costs of type 2 diabetic patients		12 months
Secondary	evaluation of patient satisfaction using spanish version of diabetes treatment satisfaction questionnaire (DTSQ)		12 months
Secondary	control of risk factors, smoking and exercise: Patient Activation Measure questionnaire		12 months
Secondary	evaluation of therapeutic inertia: specific questionnaire created by Redgedaps		12 months
Secondary	evaluation of quality of life using spanish version of diabetes quality of life questionnaire (EsDQOL)		12 months