Effectiveness of Two Interventions in Patients With Low Educational Level With Diabetes to Reduce Inequalities in Self-care Behavior

Study Overview
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Brief Summary
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The purpose of this cluster randomized trial is to determine whether an intervention implemented in a General Surgery, based in improving patient-provider communication, results in a better diabetes self-management in patients with lower educational level. A secondary objective is to assess whether telephone reinforcement enhances the effect of such intervention.

Conditions
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Diabetes Mellitus Type 2

Intervention / Treatment
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* Other: Face-to-face
* Other: Face-to-face intervention plus telephone reinforcement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of DM2, Over 18 years, Low educational level (no college to GBS or ESO), Inadequate glycemic control (glycosylated hemoglobin levels above 7%) Exclusion Criteria: Physical or mental condition that prevents the completion of the intervention - complications arising from severe DM2 altering routine medical monitoring.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention A<br>Face-to face intervention | Other: Face-to-face<br>* is carried out by the GPs during the clinic visit and consists of seven visits, one every three months. Each session consists of completing a diabetes care record sheet (DCRS) together with the patient. The DCRS consists of two parts: Five questions on self-care activities in the last three months and a graph with previously measured HbA1c levels. This information is completed at each session, resulting in a graph showing the evolution of glycaemic control related to self-care activities. The DCRS is explained patients, emphasising the relationship between self-care and glycemic control. At the end of the session, patients are given a copy of the DCRS and suggested to show it and discuss it with their relatives.<br>|
| Experimental: Intervention B<br>Face-to-face intervention plus telephone reinforcement | Other: Face-to-face intervention plus telephone reinforcement<br>* In this group patients receive the above described intervention A plus a telephone reinforcement It consists on five telephone calls lasting about 10 minutes each, to provide advice on carrying out physical exercise and eating a balanced diet and to encourage the use of health services related to diabetes control. Any problems or doubts that patients have stemming from any aspect of diabetes care are also discussed. Telephone reinforcement is carried out by a professional who has previously been trained in promoting T2DM self-management and in motivational interviewing techniques.<br>|
| No Intervention: Control Group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycosylated Haemoglobin levels |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes self-management,, Quality of diabetes care, Diabetes Mellitus type 2;, Primary Care, healthcare inequalities;