Clinical Trial on Diabetes Expert Patients Programme (EPPD-ICS)

Expert Patients Programme Effectiveness on Diabetes Control. A Controlled Clinical Trial

The purpose of this study is to determine whether participation in a diabetes expert patients programme course is effective in self-management of a chronic condition such as diabetes, if it reduces Haemoglobin A glycosylated levels, improves patient's quality of life, and prevents the use of some health services.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: Diabetes expert patients programme

Detailed Description

The intervention consists in taking part in a diabetes expert patients programme course led by a teaching patient who has experience on chronic disease since he also suffers diabetes. The course is intended for 10 to 15 patients and it is scheduled on 9-weekly sessions (about two hours each session). A nurse supervises the group and observes it without taking part neither on dialogs nor presentations; this nurse helps teaching patient only on logistic needs.

First session main contents are on group operation rules (informed consent expression, confidentiality rules, ...), on reasons and expected results of this kind of self-care support programmes and on general aims and purposes. After explanations, patients are invited to answer a set of validated questionnaires on social, demographic and clinical data (including treatments and comorbidities), diabetes knowledge, self-care and self-assessment and quality of life. In this session body weight, arterial pressure and waist perimeter are also measured and registered. The most recent value (until three months before inclusion) of Haemoglobin A glycosylated will be collected from the lab information system.

The following sessions (from second to ninth) will approach several disease aspects like: what diabetes is, its diagnostic and treatment, acute and chronic complications, food and eating habits, physical exercise and healthy lifestyles, treatment (drugs and insulin) and disease self-control and self-care.

When intervention finishes, a follow-up period starts. At eighth and at 14th month from inclusion, participants will be summoned to provide again answers to questionnaires on knowledge, self-care, and quality of life. At both times, levels of Haemoglobin A glycosylated are also measured.

Patients assigned at control branch are summoned at inclusion to obtain complete baseline data, and also at month 8th and at month 14th. On these three occasions, these subjects answer the same questionnaires (including clinical, morbidity data and lab information) administered to intervention group patients.

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pere Roura-Poch, MD, MPH; Phone Number: +34.93.693.00.40; Email: proura@chv.cat
• Study Contact Backup: Name: Dolores Álamo-Junquera, MD, MPH; Phone Number: +34.93.693.00.40; Email: mdalamo.cc.ics@gencat.cat

Study Locations

• Spain
  • Catalonia
    • Barcelona, Catalonia, Spain, 08007
      • Not yet recruiting
      • Catalan Health Institute, Barcelona District health Authority
      • Contact: Pere Roura-Poch, MD, MPH; Email: proura@chv.cat
      • Sub-Investigator: Asunción González-Mestre, RN
      • Sub-Investigator: Paloma Amil, RN
      • Sub-Investigator: Claustre Solé, RN
      • Sub-Investigator: Ester Gil, RN
    • L'Hospitalet de Llobregat, Catalonia, Spain, 08908
      • Not yet recruiting
      • Catalan Health Institute, Sud metropolitan District health Authority
      • Contact: Pere Roura-Poch, MD, MPH; Email: proura@chv.cat
      • Sub-Investigator: Rosa M García-Cerdán, RN
    • Sant Fruitós de Bages, Catalonia, Spain, 08272
      • Recruiting
      • Catalan Health Institute, Catalonia midlands District health Authority
      • Contact: Pere Roura-Poch, MD, MPH; Phone Number: +34.93.693.00.40; Email: proura@chv.cat
      • Principal Investigator: Carme Boix, RN
      • Sub-Investigator: Pere Roura-Poch, MD, MPH
      • Sub-Investigator: Dolores Álamo-Junquera, MD, MPH
      • Sub-Investigator: Núria Sala, RN, MPH
      • Sub-Investigator: Joan P Millet, MD, MPH, PhD
      • Sub-Investigator: Joan Tobías, MD
      • Sub-Investigator: Marta A Palou, RN
      • Sub-Investigator: Montserrat Sallés, RN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diabetes mellitus, Type 2
• Older than 18

Exclusion Criteria:

• Dementia
• Psychosis
• Home nursing
• Mental disabled people
• Subjects unable to express themselves in Spanish or catalan languages
• Health professionals
• Subjects included simultaneously in other lifestyle counseling or health education programmes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diabetes expert patients programme; Diabetes expert patients programme: Participate in a scheduled and standardized expert patients programme course	Behavioral: Diabetes expert patients programme; Nine-weekly informative and educational sessions by a teaching patient who has experience on diabetes
Placebo Comparator: No intervention; Don't participate in a scheduled and standardized expert patients programme course

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycosylated hemoglobin A	Change in glycosylated hemoglobin A percentage level	At baseline, and at 8th and 14th months of follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health related quality of life	Change in scores from Diabetes quality of life questionnaire	At baseline, and at 8th and 14th months of follow-up
Health services utilization	Number of general practitioner consultations, number of outpatient visits, number of emergency department visits, number of hospital admissions and length of stay. All of them diabetes related.	12 months before inclusion and 12 months after intervention ends

Collaborators and Investigators

• Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Collaborators: Catalan Institute of Health
• Investigators: Principal Investigator: Carme Boix, RN, Catalan Institute of Health; Study Director: Pere Roura-Poch, MD, MPH, Catalan Institute of Health

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Anticipated): April 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: July 10, 2013
• First Submitted That Met QC Criteria: July 11, 2013
• First Posted (Estimate): July 12, 2013

Study Record Updates

• Last Update Posted (Estimate): July 23, 2013
• Last Update Submitted That Met QC Criteria: July 21, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: EPPD-2012-ICS