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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Clara Bermúdez-Tamayo, Andalusian School of Public Health
ClinicalTrials.gov Identifier:
NCT01849731
First received: May 6, 2013
Last updated: NA
Last verified: May 2013
History: No changes posted

May 6, 2013
May 6, 2013
February 2011
December 2012   (final data collection date for primary outcome measure)
Glycosylated Haemoglobin levels [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
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Effectiveness of Two Interventions in Patients With Low Educational Level With Diabetes to Reduce Inequalities in Self-care Behavior
Not Provided

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.

Not Provided
Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Diabetes Mellitus Type 2
  • 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.
  • Other: 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.
  • Experimental: Intervention A
    Face-to face intervention
    Intervention: Other: Face-to-face
  • Experimental: Intervention B
    Face-to-face intervention plus telephone reinforcement
    Intervention: Other: Face-to-face intervention plus telephone reinforcement
  • No Intervention: Control Group
Ricci-Cabello I, Olry de Labry-Lima A, Bolívar-Muñoz J, Pastor-Moreno G, Bermudez-Tamayo C, Ruiz-Pérez I, Quesada-Jiménez F, Moratalla-López E, Domínguez-Martín S, de los Ríos-Álvarez AM, Cruz-Vela P, Prados-Quel MA, López-De Hierro JA. Effectiveness of two interventions based on improving patient-practitioner communication on diabetes self-management in patients with low educational level: study protocol of a clustered randomized trial in primary care. BMC Health Serv Res. 2013 Oct 23;13:433. doi: 10.1186/1472-6963-13-433.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
184
Not Provided
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01849731
PI-0096-2010
No
Clara Bermúdez-Tamayo, Andalusian School of Public Health
Andalusian School of Public Health
Not Provided
Not Provided
Andalusian School of Public Health
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP