Clinical Trial on Diabetes Expert Patients Programme

NCT ID: NCT01898702

Last Updated: 2013-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Diabetes expert patients programme

Diabetes expert patients programme: Participate in a scheduled and standardized expert patients programme course

Group Type EXPERIMENTAL

Diabetes expert patients programme

Intervention Type BEHAVIORAL

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

No intervention

Don't participate in a scheduled and standardized expert patients programme course

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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Diabetes expert patients programme

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Catalan Institute of Health

OTHER_GOV

Sponsor Role collaborator

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carme Boix, RN

Role: PRINCIPAL_INVESTIGATOR

Catalan Institute of Health

Pere Roura-Poch, MD, MPH

Role: STUDY_DIRECTOR

Catalan Institute of Health

Locations

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Catalan Health Institute, Barcelona District health Authority

Barcelona, Catalonia, Spain

Site Status NOT_YET_RECRUITING

Catalan Health Institute, Sud metropolitan District health Authority

L'Hospitalet de Llobregat, Catalonia, Spain

Site Status NOT_YET_RECRUITING

Catalan Health Institute, Catalonia midlands District health Authority

Sant Fruitós de Bages, Catalonia, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Pere Roura-Poch, MD, MPH

Role: CONTACT

+34.93.693.00.40

Dolores Álamo-Junquera, MD, MPH

Role: CONTACT

+34.93.693.00.40

Facility Contacts

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Pere Roura-Poch, MD, MPH

Role: primary

Pere Roura-Poch, MD, MPH

Role: primary

Pere Roura-Poch, MD, MPH

Role: primary

+34.93.693.00.40

Other Identifiers

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EPPD-2012-ICS

Identifier Type: -

Identifier Source: org_study_id

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