Effectiveness of Two Interventions in Patients With Low Educational Level With Diabetes to Reduce Inequalities in Self-care Behavior

NCT01849731 | Completed

• 1 other identifier: PI-0096-2010
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus Type 2

Keywords

Diabetes Mellitus type 2;; Primary Care, healthcare inequalities;; Diabetes self-management,; Quality of diabetes care

Outcome Measures

Primary Outcomes (1)

• Glycosylated Haemoglobin levels

  one year

Study Arms (3)

Intervention A

EXPERIMENTAL

Face-to face intervention

Other: Face-to-face

Intervention B

EXPERIMENTAL

Face-to-face intervention plus telephone reinforcement

Other: Face-to-face intervention plus telephone reinforcement

Control Group

NO INTERVENTION

Interventions

Face-to-face OTHER

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.

Intervention A

Face-to-face intervention plus telephone reinforcement OTHER

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.

Intervention B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of DM2,
• Over 18 years,
• Low educational level (no college to GBS or ESO),
• Inadequate glycemic control (glycosylated hemoglobin levels above 7%)

You may not qualify if:

• Physical or mental condition that prevents the completion of the intervention - complications arising from severe DM2 altering routine medical monitoring.

Sponsors & Collaborators

• Andalusian School of Public Health: lead

Study Sites (1)

Andalussian School of Public Health

Granada, Granada, 18011, Spain

Location

Related Publications (1)

• Ricci-Cabello I, Olry de Labry-Lima A, Bolivar-Munoz J, Pastor-Moreno G, Bermudez-Tamayo C, Ruiz-Perez I, Quesada-Jimenez F, Moratalla-Lopez E, Dominguez-Martin S, de los Rios-Alvarez AM, Cruz-Vela P, Prados-Quel MA, Lopez-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.

  PMID: 24153053 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD in Health Economics

Study Record Dates

• First Submitted: May 6, 2013
• First Posted: May 8, 2013
• Study Start: February 1, 2011
• Primary Completion: December 1, 2012
• Last Updated: May 8, 2013

Record last verified: 2013-05

Locations

ES (1)