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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
Sponsor:
Information provided by (Responsible Party):
Clara Bermúdez-Tamayo, Andalusian School of Public Health

Tracking Information
First Submitted Date  ICMJE May 6, 2013
First Posted Date  ICMJE May 8, 2013
Last Update Posted Date May 8, 2013
Study Start Date  ICMJE February 2011
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2013)
Glycosylated Haemoglobin levels [ Time Frame: one year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Two Interventions in Patients With Low Educational Level With Diabetes to Reduce Inequalities in Self-care Behavior
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Diabetes Mellitus Type 2
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 6, 2013)
184
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01849731
Other Study ID Numbers  ICMJE PI-0096-2010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Clara Bermúdez-Tamayo, Andalusian School of Public Health
Study Sponsor  ICMJE Andalusian School of Public Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Andalusian School of Public Health
Verification Date May 2013

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