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

NCT ID: NCT01849731

Last Updated: 2013-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention A

Face-to face intervention

Group Type: EXPERIMENTAL

Face-to-face

Intervention Type: 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 B

Face-to-face intervention plus telephone reinforcement

Group Type: EXPERIMENTAL

Face-to-face intervention plus telephone reinforcement

Intervention Type: 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.

Control Group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Andalusian School of Public Health

OTHER_GOV

Sponsor Role: lead

Responsible Party

Clara Bermúdez-Tamayo

PhD in Health Economics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Andalussian School of Public Health

Granada, Granada, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 24153053 (View on PubMed)

Other Identifiers

PI-0096-2010

Identifier Type: -

Identifier Source: org_study_id