Clinical Trial on Diabetes Expert Patients Programme

Diabetes Mellitus, Type 2 Clinical Trial

— EPPD-ICS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01898702
• Other study ID #: EPPD-2012-ICS
• Status: Recruiting
• Phase: N/A
• First received: July 10, 2013
• Last updated: July 21, 2013
• Start date: May 2013
• Est. completion date: December 2015

Study information

• Verified date: July 2013
• Source: Jordi Gol i Gurina Foundation
• Contact: Pere Roura-Poch, MD, MPH
• Phone: +34.93.693.00.40
• Email: proura[@]chv.cat
• Is FDA regulated: No
• Health authority: Spain: Departament de Salut de la Generalitat de Catalunya
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Diabetes expert patients programme
Nine-weekly informative and educational sessions by a teaching patient who has experience on diabetes

Locations

Country	Name	City	State
Spain	Catalan Health Institute, Barcelona District health Authority	Barcelona	Catalonia
Spain	Catalan Health Institute, Sud metropolitan District health Authority	L'Hospitalet de Llobregat	Catalonia
Spain	Catalan Health Institute, Catalonia midlands District health Authority	Sant Fruitós de Bages	Catalonia

Sponsors (2)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation	Catalan Institute of Health

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycosylated hemoglobin A	Change in glycosylated hemoglobin A percentage level	At baseline, and at 8th and 14th months of follow-up	No
Secondary	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	No
Secondary	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	No