title: 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.
abstract: BACKGROUND
  In the last decades the presence of social inequalities in diabetes care has been observed in multiple countries, including Spain. These inequalities have been at least partially attributed to differences in diabetes self-management behaviours. Communication problems during medical consultations occur more frequently to patients with a lower educational level. 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. We report the design and implementation of this on-going study.
  
  
  METHODS
  The study is being conducted in a General Practice located in a deprived neighbourhood of Granada, Spain. Diabetic patients 18 years old or older with a low educational level and inadequate glycaemic control (HbA1c > 7%) were recruited. General Practitioners (GPs) were randomised to three groups: intervention A, intervention B and control group. GPs allocated to intervention groups A and B received training in communication skills and are providing graphic feedback about glycosylated haemoglobin levels. Patients whose GPs were allocated to group B are additionally receiving telephone reinforcement whereas patients from the control group are receiving usual care. The described interventions are being conducted during 7 consecutive medical visits which are scheduled every three months. The main outcome measure will be HbA1c; blood pressure, lipidemia, body mass index and waist circumference will be considered as secondary outcome measures. Statistical analysis to evaluate the effectiveness of the interventions will include multilevel regression analysis with three hierarchical levels: medical visit level, patient level and GP level.
  
  
  CONCLUSIONS
  The results of this study will provide new knowledge about possible strategies to promote a better diabetes self-management in a particularly vulnerable group. If effective, this low cost intervention will have the potential to be easily incorporated into routine clinical practice, contributing to decrease health inequalities in diabetic patients.
  
  
  BACKGROUND
  Clinical Trials U.S. National Institutes of Health, NCT01849731.
authors.forename: Ignacio
authors.initials: I
authors.lastname: Ricci-Cabello
authors.forename: Antonio
authors.initials: A
authors.lastname: Olry de Labry-Lima
authors.forename: Julia
authors.initials: J
authors.lastname: Bolívar-Muñoz
authors.forename: Guadalupe
authors.initials: G
authors.lastname: Pastor-Moreno
authors.forename: Clara
authors.initials: C
authors.lastname: Bermudez-Tamayo
authors.affiliation: Escuela Andaluza de Salud Pública, Campus Universitario de Cartuja, Cuesta del Observatorio 4, Apdo, 2070, 18080, Granada, Spain. isabel.ruiz.easp@juntadeandalucia.es.
authors.forename: Isabel
authors.initials: I
authors.lastname: Ruiz-Pérez
authors.forename: Fermín
authors.initials: F
authors.lastname: Quesada-Jiménez
authors.forename: Enrique
authors.initials: E
authors.lastname: Moratalla-López
authors.forename: Susana
authors.initials: S
authors.lastname: Domínguez-Martín
authors.forename: Ana M
authors.initials: AM
authors.lastname: de los Ríos-Álvarez
authors.forename: Pilar
authors.initials: P
authors.lastname: Cruz-Vela
authors.forename: Miguel A
authors.initials: MA
authors.lastname: Prados-Quel
authors.forename: José A
authors.initials: JA
authors.lastname: López-De Hierro
mesh_terms: D002985:Clinical Protocols; D003142:Communication; D003924:Diabetes Mellitus, Type 2 / Q000523:psychology / Q000628:therapy*; D004522:Educational Status; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D057220:Health Literacy; D006801:Humans; D008297:Male; D008875:Middle Aged; D010817:Physician-Patient Relations; D011320:Primary Health Care / Q000379:methods*; D015397:Program Evaluation; D017010:Reminder Systems; D012648:Self Care / Q000379:methods* / Q000523:psychology
chemical_list: D006442:Glycated Hemoglobin; C517652:hemoglobin A1c protein, human