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

NCT01642394 | Completed

• 1 other identifier: KRONIK11/036
• Study Type: interventional
• Target: 594
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Mellitus

Keywords

Diabetes Mellitus; Chronic Disease; Education; Primary Care; Self care; Self Management

Outcome Measures

Primary Outcomes (1)

• Change in Glycated hemoglobin

  The investigators are going to measure the diference between basal Glycated Hemoglobin and 6,12 and 24 months Glycated Hemoglobin.

  Measurements will be carried out before intervention and 6, 12 and 24 months after intervention

Secondary Outcomes (16)

• Change in Cardiovascular risk

  Measurements will be carried out before intervention and 6, 12 and 24 months after intervention

• Change in quality of life

  Measurements will be carried out before intervention and 6, 12 and 24 months after intervention

• Change in self efficacy

  Measurements will be carried out before intervention and 6, 12 and 24 months after intervention

• Change in health services utilization

  Measurements will be carried out before intervention and 6, 12 and 24 months after intervention

• Introduction or removal of hypoglycaemic drugs

  Measurements will be carried out before intervention and 6, 12 and 24 months after intervention

Study Arms (2)

Standardized care

NO INTERVENTION

The control group will receive usual care for secondary prevention of type 2 diabetes according to usual care in Osakidetza's primary care.

Self-management education programme

EXPERIMENTAL

Attendees will receive the Diabetes Self-Management Programme in spanish version (Manejo personal de la diabetes).

Behavioral: Diabetes Self-Management Program

Interventions

Diabetes Self-Management Program BEHAVIORAL

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.

Also known as: Diabetes Self-Management Programme

Self-management education programme

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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".

You may not qualify if:

• 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.

Sponsors & Collaborators

• Osakidetza: lead
• Kronikgune-- Association Centre of International Excellence in Research on Chronicity: collaborator
• Department of Health Basque Government: collaborator
• Fondo de Investigacion Sanitaria: collaborator

Study Sites (1)

Osakidetza

Vitoria-Gasteiz, Alava, 01006, Spain

Location

Related Publications (3)

• Gamboa Moreno E, Mateo-Abad M, Ochoa de Retana Garcia L, Vrotsou K, Del Campo Pena E, Sanchez Perez A, Martinez Carazo C, Arbonies Ortiz JC, Rua Portu MA, Pinera Elorriaga K, Zenarutzabeitia Pikatza A, Urquiza Bengoa MN, Mendez Sanpedro T, Oses Portu A, Aguirre Sorondo MB, Rotaeche Del Campo R; Osakidetza Active Patient Research Group. Efficacy of a self-management education programme on patients with type 2 diabetes in primary care: A randomised controlled trial. Prim Care Diabetes. 2019 Apr;13(2):122-133. doi: 10.1016/j.pcd.2018.10.001. Epub 2018 Nov 6.

  PMID: 30409669 DERIVED

• Gamboa Moreno E, Ochoa de Retana Garcia L, Del Campo Pena ME, Sanchez Perez A, Martinez Carazo C, Arbonies Ortiz JC, Rua Portu MA, Pinera Elorriaga K, Zenarutzabeitia Pikatza A, Urquiza Bengoa MN, Mendez Sanpedro T, Oses Portu A, Gorostidi Fano L, Aguirre Sorondo MB, Vrotsou K, Rotaeche Del Campo R. A Pilot Study to Assess the Feasibility of the Spanish Diabetes Self-Management Program in the Basque Country. J Diabetes Res. 2016;2016:9145673. doi: 10.1155/2016/9145673. Epub 2016 Dec 29.

  PMID: 28119932 DERIVED

• Gamboa Moreno E, Sanchez Perez A, Vrotsou K, Arbonies Ortiz JC, Del Campo Pena E, Ochoa de Retana Garcia L, Rua Portu MA, Pinera Elorriaga K, Zenarutzabeitia Pikatza A, Urquiza Bengoa MN, Sanz Echave R, Mendez Sampedro T, Oses Portu A, Gorostidi Fano L, Aguirre Sorondo MB, Rotaeche Del Campo R; Osakidetza Active Patient Research Group. Impact of a self-care education programme on patients with type 2 diabetes in primary care in the Basque Country. BMC Public Health. 2013 May 29;13:521. doi: 10.1186/1471-2458-13-521.

  PMID: 23718222 DERIVED

Related Links

• In this URL you can read more information about the self-management program we are using.

MeSH Terms

Conditions

Diabetes Mellitus; Chronic Disease

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Estibaliz Gamboa Moreno, Nurse

  Osakidetza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Diploma of Nursing

Model Details: Intervention group The complete intervention consists of group sessions (8 to 15 people) lasting 2.5 hours, once a week for six weeks. These sessions are structured with the aim of enabling participants to acquire knowledge and skills related to the disease and its management, placing a strong emphasis on proactive tools to achieve healthier lifestyles (in terms of diet, physical exercise, management of emotions, and correct use of medication, among others). Control group Patients assigned to the control group will receive usual care for secondary prevention of DM2 in accordance with the Osakidetza primary care protocols, which are based on clinical practice guidelines.

Study Record Dates

• First Submitted: May 16, 2012
• First Posted: July 17, 2012
• Study Start: October 1, 2011
• Primary Completion: December 30, 2014
• Study Completion: December 1, 2016
• Last Updated: November 17, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)