Clinical trial NCT01898702: Clinical Trial on Diabetes Expert Patients Programme
Official title: Expert Patients Programme Effectiveness on Diabetes Control. A Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Catalan Institute of Health
First posted: 2013-07-12
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Glycosylated hemoglobin A
timeFrame: At baseline, and at 8th and 14th months of follow-up
Secondary outcomes:
measure: Health related quality of life
timeFrame: At baseline, and at 8th and 14th months of follow-up
measure: Health services utilization
timeFrame: 12 months before inclusion and 12 months after intervention ends
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Catalan Health Institute, Barcelona District health Authority
state: Catalonia
city: L'Hospitalet de Llobregat
country: Spain
facility: Catalan Health Institute, Sud metropolitan District health Authority
state: Catalonia
city: Sant Fruitós de Bages
country: Spain
facility: Catalan Health Institute, Catalonia midlands District health Authority
state: Catalonia
Study officials:
affiliation: Catalan Institute of Health
name: Carme Boix, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Catalan Institute of Health
name: Pere Roura-Poch, MD, MPH
role: STUDY_DIRECTOR
References: