CClinicalTrials.gg
Status unknownNCT01898702EPPD-ICSUpdated Jul 23, 2013

Clinical Trial on Diabetes Expert Patients Programme

An interventional study of Diabetes expert patients programme in Diabetes Mellitus, Type 2, sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina. Status unknown at 3 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-07-23.

Sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Jul 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 500 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina is the lead sponsor of 158 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diabetes mellitus, Type 2
  • Older than 18

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
500 participants (estimated)

Study arms

  • Experimental
    Diabetes expert patients programme

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

    Behavioral: Diabetes expert patients programme

  • Placebo comparator
    No intervention

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

Interventions

  • BehavioralDiabetes expert patients programme

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

06

What researchers measure

Primary outcomes

  1. Glycosylated hemoglobin A

    Change in glycosylated hemoglobin A percentage level

    Time frame: At baseline, and at 8th and 14th months of follow-up

Secondary outcomes

  1. Health related quality of life

    Change in scores from Diabetes quality of life questionnaire

    Time frame: At baseline, and at 8th and 14th months of follow-up

  2. Health services utilization

    Number 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.

    Time frame: 12 months before inclusion and 12 months after intervention ends

07

Study locations

1 of 3 sites recruiting
  • Catalan Health Institute, Barcelona District health Authority
    Barcelona, Catalonia 08007, Spain
    • Pere Roura-Poch, MD, MPH · Contact · proura@chv.cat
    • Asunción González-Mestre, RN · Sub investigator
    • Paloma Amil, RN · Sub investigator
    • Claustre Solé, RN · Sub investigator
    • Ester Gil, RN · Sub investigator
    Not yet recruiting
  • Catalan Health Institute, Sud metropolitan District health Authority
    L'Hospitalet de Llobregat, Catalonia 08908, Spain
    • Pere Roura-Poch, MD, MPH · Contact · proura@chv.cat
    • Rosa M García-Cerdán, RN · Sub investigator
    Not yet recruiting
  • Catalan Health Institute, Catalonia midlands District health Authority
    Sant Fruitós de Bages, Catalonia 08272, Spain
    • Pere Roura-Poch, MD, MPH · Contact · proura@chv.cat · +34.93.693.00.40
    • Carme Boix, RN · Principal investigator
    • Pere Roura-Poch, MD, MPH · Sub investigator
    • Dolores Álamo-Junquera, MD, MPH · Sub investigator
    • Núria Sala, RN, MPH · Sub investigator
    • Joan P Millet, MD, MPH, PhD · Sub investigator
    • Joan Tobías, MD · Sub investigator
    • Marta A Palou, RN · Sub investigator
    • Montserrat Sallés, RN · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01898702
Lead sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Catalan Institute of Health
Responsible party
Sponsor
First posted
Jul 12, 2013
Start date
May 2013
Primary completion
Apr 2015 (estimated)
Completion
Dec 2015 (estimated)
Last update
Jul 23, 2013

Study contacts

Pere Roura-Poch, MD, MPH
Contact
proura@chv.cat
+34.93.693.00.40
Dolores Álamo-Junquera, MD, MPH
Contact
mdalamo.cc.ics@gencat.cat
+34.93.693.00.40
Carme Boix, RN
principal investigator · Catalan Institute of Health
Pere Roura-Poch, MD, MPH
study director · Catalan Institute of Health

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion