INTEGRA Study: Primary Care Intervention in Type 2 Diabetes Patients With Poor Glycaemic Control
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

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
    


Intervention name(s): Intervention 1; Intervention 2
Intervention type(s): Other; Other
Intervention description(s): 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.; 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.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Type 2 diabetes mellitus; glycemic control