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

F

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Status

Unknown

Conditions

Diabetes Mellitus, Type 2

Treatments

Behavioral: Diabetes expert patients programme

Study type

Interventional

Funder types

Other

Identifiers

NCT01898702
EPPD-2012-ICS

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

500 participants in 2 patient groups, including a placebo group

Diabetes expert patients programme
Experimental group
Description:
Diabetes expert patients programme: Participate in a scheduled and standardized expert patients programme course
Treatment:
Behavioral: Diabetes expert patients programme
No intervention
Placebo Comparator group
Description:
Don't participate in a scheduled and standardized expert patients programme course

Trial contacts and locations

3

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Central trial contact

Dolores Álamo-Junquera, MD, MPH; Pere Roura-Poch, MD, MPH

Data sourced from clinicaltrials.gov

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