Effectiveness of an intervention to improve diabetes self-management on clinical outcomes in patients with low educational level / Efectividad de una intervención para mejorar los resultados clínicos con autogestión de la diabetes en pacientes con bajo nivel educativo

Objective: To determine whether an intervention based on patient-practitioner communication is more effective than usual care in improving diabetes self-management in patients with type 2 diabetes with low educational level. Methods: 12-month, pragmatic cluster randomised controlled trial. Nine physicians and 184 patients registered at two practices in a deprived area of Granada (Andalusia, Spain) participated in the study. Adult patients with type 2 diabetes, low educational level and glycated haemoglobin (HbA1c) > 7% (53.01 mmol/mol) were eligible. The physicians in the intervention group received training on communication skills and the use of a tool for monitoring glycaemic control and providing feedback to patients. The control group continued standard care. The primary outcome was difference in HbA1c after 12 months. Dyslipidaemia, blood pressure, body mass index and waist circumference were also assessed as secondary outcomes. Two-level (patient and provider) regression analyses controlling for sex, social support and comorbidity were conducted. Results: The HbA1c levels at 12 months decreased in both groups. Multilevel analysis showed a greater improvement in the intervention group (between-group HbA1c difference= 0.16; p=0.049). No statistically significant differences between groups were observed for dyslipidaemia, blood pressure, body mass index and waist circumference. Conclusions: In this pragmatic study, a simple and inexpensive intervention delivered in primary care showed a modest benefit in glycaemic control compared with usual care, although no effect was observed in the secondary outcomes. Further research is needed to design and assess interventions to promote diabetes self-management in socially vulnerable patients (AU)

Objetivo: Determinar si una intervención basada en la comunicación médico-paciente es más efectiva que la atención habitual en la mejora del autocontrol de la diabetes en pacientes con diabetes tipo 2 con bajo nivel educativo. Métodos: Ensayo controlado aleatorizado pragmático por agrupación de 12 meses. Participaron en el estudio nueve profesionales médicos y 184 pacientes registrados/as en dos centros de salud en una zona pobre de Granada (Andalucía, España). Criterios de inclusión: adultos/as con diagnóstico de diabetes tipo 2, con bajo nivel educativo y hemoglobina glucosilada (HbA1c) >7% (53,01mmol/mol). Los/las sanitarios/as del grupo de intervención recibieron entrenamiento en las habilidades de comunicación y en el uso de una herramienta para la monitorización del control glucémico y proporcionar información a los/las pacientes. El grupo control continuó la atención estándar. La medida de resultado fue la diferencia en la HbA1c después de 12 meses. Otras medidas de resultado fueron la dislipidemia, la hipertensión arterial, el índice de masa corporal y la circunferencia abdominal. Se realizó una regresión con dos niveles (paciente y proveedor) controlando por sexo, apoyo social y comorbilidad. Resultados: La HbA1c a los 12 meses disminuyó en ambos grupos. El análisis multinivel mostró una mayor mejoría en el grupo de intervención (diferencia entre grupos HbA1c=−0,16; p=0,049). No se observaron diferencias estadísticamente significativas entre los grupos para la dislipidemia, la hipertensión arterial, el índice de masa corporal y la circunferencia abdominal. Conclusiones: Este estudio pragmático mostró que una intervención sencilla y de bajo coste ofrecida en atención primaria alcanzó un modesto beneficio en el control glucémico en comparación con la atención habitual, aunque no se observó ningún efecto en los resultados secundarios. Se necesita más investigación para diseñar y evaluar intervenciones para promover el autocontrol de la diabetes en pacientes socialmente vulnerables (AU)

Effectiveness of an intervention to improve diabetes self-management on clinical outcomes in patients with low educational level.

OBJECTIVE: To determine whether an intervention based on patient-practitioner communication is more effective than usual care in improving diabetes self-management in patients with type 2 diabetes with low educational level. METHODS: 12-month, pragmatic cluster randomised controlled trial. Nine physicians and 184 patients registered at two practices in a deprived area of Granada (Andalusia, Spain) participated in the study. Adult patients with type 2 diabetes, low educational level and glycated haemoglobin (HbA1c) > 7% (53.01 mmol/mol) were eligible. The physicians in the intervention group received training on communication skills and the use of a tool for monitoring glycaemic control and providing feedback to patients. The control group continued standard care. The primary outcome was difference in HbA1c after 12 months. Dyslipidaemia, blood pressure, body mass index and waist circumference were also assessed as secondary outcomes. Two-level (patient and provider) regression analyses controlling for sex, social support and comorbidity were conducted. RESULTS: The HbA1c levels at 12 months decreased in both groups. Multilevel analysis showed a greater improvement in the intervention group (between-group HbA1c difference= 0.16; p=0.049). No statistically significant differences between groups were observed for dyslipidaemia, blood pressure, body mass index and waist circumference. CONCLUSIONS: In this pragmatic study, a simple and inexpensive intervention delivered in primary care showed a modest benefit in glycaemic control compared with usual care, although no effect was observed in the secondary outcomes. Further research is needed to design and assess interventions to promote diabetes self-management in socially vulnerable patients.

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.

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/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: Clinical Trials U.S. National Institutes of Health, NCT01849731.