Diabetes Mellitus, Type 2 Clinical Trial
Official title:
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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