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Trial record 1 of 1 for:    NCT 01849731
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Effectiveness of Two Interventions in Patients With Low Educational Level With Diabetes to Reduce Inequalities in Self-care Behavior

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ClinicalTrials.gov Identifier: NCT01849731
Recruitment Status : Completed
First Posted : May 8, 2013
Last Update Posted : May 8, 2013
Information provided by (Responsible Party):
Clara Bermúdez-Tamayo, Andalusian School of Public Health

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Other: Face-to-face Other: Face-to-face intervention plus telephone reinforcement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : February 2011
Actual Primary Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Intervention A
Face-to face 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.

Experimental: Intervention B
Face-to-face intervention plus telephone reinforcement
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.

No Intervention: Control Group

Primary Outcome Measures :
  1. Glycosylated Haemoglobin levels [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01849731

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Andalussian School of Public Health
Granada, Spain, 18011
Sponsors and Collaborators
Andalusian School of Public Health
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Clara Bermúdez-Tamayo, PhD in Health Economics, Andalusian School of Public Health
ClinicalTrials.gov Identifier: NCT01849731    
Other Study ID Numbers: PI-0096-2010
First Posted: May 8, 2013    Key Record Dates
Last Update Posted: May 8, 2013
Last Verified: May 2013
Keywords provided by Clara Bermúdez-Tamayo, Andalusian School of Public Health:
Diabetes Mellitus type 2;
Primary Care, healthcare inequalities;
Diabetes self-management,
Quality of diabetes care
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases