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
  Purpose

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 Intervention
Diabetes Mellitus Type 2
Other: Face-to-face
Other: Face-to-face intervention plus telephone reinforcement

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

Resource links provided by NLM:


Further study details as provided by Andalusian School of Public Health:

Primary Outcome Measures:
  • Glycosylated Haemoglobin levels [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 184
Study Start Date: February 2011
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01849731

Locations
Spain
Andalussian School of Public Health
Granada, Spain, 18011
Sponsors and Collaborators
Andalusian School of Public Health
  More Information

No publications provided by Andalusian School of Public Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Clara Bermúdez-Tamayo, PhD in Health Economics, Andalusian School of Public Health
ClinicalTrials.gov Identifier: NCT01849731     History of Changes
Other Study ID Numbers: PI-0096-2010
Study First Received: May 6, 2013
Last Updated: May 6, 2013
Health Authority: Spain: Ethics Committee

Keywords provided by Andalusian School of Public Health:
Diabetes Mellitus type 2;
Primary Care, healthcare inequalities;
Diabetes self-management,
Quality of diabetes care

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 01, 2014