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

Diabetes Mellitus Type 2 Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01849731
• Other study ID #: PI-0096-2010
• Status: Completed
• Phase: N/A
• First received: May 6, 2013
• Last updated: May 6, 2013
• Start date: February 2011

Study information

• Verified date: May 2013
• Source: Andalusian School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Other:
• Face-to-face
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.
• Face-to-face intervention plus telephone reinforcement
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.

Locations

Country	Name	City	State
Spain	Andalussian School of Public Health	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Andalusian School of Public Health

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycosylated Haemoglobin levels		one year	No