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Clinical Trial on Diabetes Expert Patients Programme

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01898702
Acronym
EPPD-ICS
Enrollment
500
Registered
2013-07-12
Start date
2013-05-31
Completion date
2015-12-31
Last updated
2013-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

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.

Interventions

BEHAVIORALDiabetes expert patients programme

Nine-weekly informative and educational sessions by a teaching patient who has experience on diabetes

Sponsors

Catalan Institute of Health
CollaboratorOTHER_GOV
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Glycosylated hemoglobin AAt baseline, and at 8th and 14th months of follow-upChange in glycosylated hemoglobin A percentage level

Secondary

MeasureTime frameDescription
Health related quality of lifeAt baseline, and at 8th and 14th months of follow-upChange in scores from Diabetes quality of life questionnaire
Health services utilization12 months before inclusion and 12 months after intervention endsNumber 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.

Countries

Spain

Contacts

Primary ContactPere Roura-Poch, MD, MPH
proura@chv.cat+34.93.693.00.40
Backup ContactDolores Álamo-Junquera, MD, MPH
mdalamo.cc.ics@gencat.cat+34.93.693.00.40

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026