Impact of Self-care Education Program in Patients With Type 2 Diabetes in Primary Care in the Basque Country

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Kronikgune-- Association Centre of International Excellence in Research on Chronicity
Department of Health Basque Government
Fondo de Investigacion Sanitaria
Information provided by (Responsible Party):
Estibaliz Gamboa Moreno, Osakidetza
ClinicalTrials.gov Identifier:
NCT01642394
First received: May 16, 2012
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

Main objective:To evaluate the effectiveness of the "Diabetes Self-Management Programme" (DSMP) on the metabolic control, cardiovascular risk reduction, quality of life and self-efficacy in adult patients with type 2 diabetes, compared with current standard care of patients with type 2 diabetes, in the context of Osakidetza's Primary Care network.

Secondary objectives:

  • To evaluate the impact of the implementation of DSMP in the use of health services.
  • To assess the impact of DSMP in the cost of treatment of the involved population.
  • To evaluate the improvement in physical activity and diet patterns among the participants.
  • To describe the feasibility of implementing the DSMP in the Basque Country's primary health care system Methodology: Randomized clinical trial in which patients diagnosed with type 2 diabetes aged between 18 and 80 years pertaining to 4 primary regions of the Basque country, who agree to participate in the study, will be randomly assigned to two groups: the intervention group (the DSMP programme) and the control group. The intervention will be performed by trained patients with type 2 diabetes and health professionals and it will consist in 6 group sessions of two and a half hours each, on a weekly basis with a overall duration of 6 weeks. The session content includes techniques for dealing with problems, promotion of exercise, nutrition concepts, proper use of medication, effective communication and basic knowledge about diabetes and its complications. The sessions are supported with educational material. The main outcome is the improvement of HbA1c (glycated hemoglobin) levels. Secondary outcomes are reduction of cardiovascular risk, increase of quality of life and self-efficacy. The results will be analyzed at 6, 12 and 24 months after the intervention.

Hypothesis: An educational intervention on patients with type 2 diabetes mellitus based on the program DSMP conducted by previously trained lay persons and health professionals, improve metabolic control as measured on a 0.5% decrease in Hb A1c (Clar, 2010),compared to regular health education. On the other hand, it is expected to see improvements in the quality of life for these patients. The intervention may reduce the weight and cardiovascular risk due to changes in the physical activity and diet patterns, getting to a more appropriate use of health services and medication. It is expected that changes in the variables occur 6 months after the intervention and remain over the time


Condition Intervention Phase
Diabetes Mellitus
Behavioral: Diabetes Self-Management Program
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Impact of Self-care Education Program "Active Patient" in Metabolic Control, Cardiovascular Risk and Quality of Life in Patients With Type 2 Diabetes in Primary Care in the Basque Country: Randomized Clinical Trial of 2 Years of Follow up

Resource links provided by NLM:


Further study details as provided by Osakidetza:

Primary Outcome Measures:
  • Change in Glycated hemoglobin [ Time Frame: Measurements will be carried out before intervention and 6, 12 and 24 months after intervention ] [ Designated as safety issue: No ]
    We are going to measure the diference between basal Glycated Hemoglobin and 6,12 and 24 months Glycated Hemoglobin.


Secondary Outcome Measures:
  • Change in Cardiovascular risk [ Time Frame: Measurements will be carried out before intervention and 6, 12 and 24 months after intervention ] [ Designated as safety issue: No ]
    We´ll use the Framingham-Regicor function

  • Change in quality of life [ Time Frame: Measurements will be carried out before intervention and 6, 12 and 24 months after intervention ] [ Designated as safety issue: No ]
    We´ll use the ADDQoL-19

  • Change in self efficacy [ Time Frame: Measurements will be carried out before intervention and 6, 12 and 24 months after intervention ] [ Designated as safety issue: No ]
    We´ll use the Stanford Spanish diabetes self-efficacy survey

  • Change in health services utilization [ Time Frame: Measurements will be carried out before intervention and 6, 12 and 24 months after intervention ] [ Designated as safety issue: No ]
  • Introduction or removal of new hypoglycaemic drugs [ Time Frame: Measurements will be carried out before intervention and 6, 12 and 24 months after intervention ] [ Designated as safety issue: No ]
  • Introduction or removal of new antiplatelet drugs [ Time Frame: Measurements will be carried out before intervention and 6, 12 and 24 months after intervention ] [ Designated as safety issue: No ]
  • Introduction or removal of new antihypertensive drugs [ Time Frame: Measurements will be carried out before intervention and 6, 12 and 24 months after intervention ] [ Designated as safety issue: No ]
  • Introduction or removal of new lipid drugs [ Time Frame: Measurements will be carried out before intervention and 6, 12 and 24 months after intervention ] [ Designated as safety issue: No ]
  • Variation in medications daily cost [ Time Frame: Measurements will be carried out before intervention and 6, 12 and 24 months after intervention ] [ Designated as safety issue: No ]
  • Change in the percentage of patients with HbA1c less than 7% [ Time Frame: Measurements will be carried out before intervention and 6, 12 and 24 months after intervention ] [ Designated as safety issue: No ]
  • Change in BMI [ Time Frame: Measurements will be carried out before intervention and 6, 12 and 24 months after intervention ] [ Designated as safety issue: No ]
    BMI (Body mass index)

  • Change in blood pressure [ Time Frame: Measurements will be carried out before intervention and 6, 12 and 24 months after intervention ] [ Designated as safety issue: No ]
  • Change in percentage of patients with SBP <140 and DBP <80 [ Time Frame: Measurements will be carried out before intervention and 6, 12 and 24 months after intervention ] [ Designated as safety issue: No ]
  • Change in the value of total cholesterol [ Time Frame: Measurements will be carried out before intervention and 6, 12 and 24 months after intervention ] [ Designated as safety issue: No ]
  • Change in the value of HDL-cholesterol [ Time Frame: Measurements will be carried out before intervention and 6, 12 and 24 months after intervention ] [ Designated as safety issue: No ]
  • Change in physical activity [ Time Frame: Measurements will be carried out before intervention and 6, 12 and 24 months after intervention ] [ Designated as safety issue: No ]
    We´ll use the 7 day Physical Activity Recall

  • Change in the diet composition [ Time Frame: Measurements will be carried out before intervention and 6, 12 and 24 months after intervention ] [ Designated as safety issue: No ]
    We´ll use the PREDIMED study survey. And we´ll study the percentage of people who declaring eat 5 or more daily pieces of fruit and vegetables.


Estimated Enrollment: 556
Study Start Date: September 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standardized care
The control group will receive usual care for secondary prevention of type 2 diabetes according to usual care in Osakidetza's primary care.
Experimental: Self-management education programme
Attendees will receive the Diabetes Self-Management Programme in spanish version (Manejo personal de la diabetes).
Behavioral: Diabetes Self-Management Program

The intervention will be performed by patients with type 2 diabetes and health professionals and it will be divided in 6 group sessions for two and a half hours each, on a weekly basis for 6 weeks. The session content includes techniques for dealing with problems in general, promotion of exercise, nutrition concepts, proper use of medication, effective communication and basic knowledge about diabetes and its complications. The sessions are supported with educational material.

Two leaders, previously trained in the DSMP, will lead each group. The leading status (patient or health care professional) is obtained after attending a 6-week structured program of training, a successful completion of 4 days of training sessions, and taking part in a full course for patients with a proven leader.

Other Name: Diabetes Self-Management Programme

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults over 18 years from four primary regions of the Basque Country: Araba, Bidasoa, Ezkerraldea- Enkarterri, Ekialde, with type 2 diabetes who have agreed to participate in the "Active Patient".

Exclusion Criteria:

  • Adults over 80 years or patients with mental disorder that distorts reality (schizophrenia, bipolar disorder, Alzheimer's disease, psychosis, dementia) or morbidity which can interfere with the course, like chronic patients at home.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01642394

Locations
Spain
Osakidetza
Vitoria, Alava, Spain, 01006
Sponsors and Collaborators
Osakidetza
Kronikgune-- Association Centre of International Excellence in Research on Chronicity
Department of Health Basque Government
Fondo de Investigacion Sanitaria
Investigators
Principal Investigator: Estibaliz Gamboa Moreno, Nurse Osakidetza
  More Information

Additional Information:
No publications provided by Osakidetza

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Estibaliz Gamboa Moreno, Diploma of Nursing, Osakidetza
ClinicalTrials.gov Identifier: NCT01642394     History of Changes
Other Study ID Numbers: KRONIK11/036
Study First Received: May 16, 2012
Last Updated: March 6, 2014
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Osakidetza:
Diabetes Mellitus
Chronic Disease
Education
Primary Care
Self care
Self Management

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 26, 2014