Diabetes Mellitus, Type 2EPPD-ICSNCT01898702
Clinical Trial on Diabetes Expert Patients Programme
A study testing Diabetes expert patients programme in people with Diabetes Mellitus, Type 2, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 3 sites in Spain.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Diabetes expert patients programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 3 sitesSpain
- Study dates
- May 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes mellitus, Type 2
- Older than 18
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
Spain3 sites, 3 recruiting
- Not yet recruiting
Catalan Health Institute, Barcelona District health Authority
Barcelona, Catalonia, 08007
Pere Roura-Poch, MD, MPH, proura@chv.cat
Asunción González-Mestre, RN
- Not yet recruiting
Catalan Health Institute, Sud metropolitan District health Authority
L'Hospitalet de Llobregat, Catalonia, 08908
Pere Roura-Poch, MD, MPH, proura@chv.cat
Rosa M García-Cerdán, RN
- Recruiting
Catalan Health Institute, Catalonia midlands District health Authority
Sant Fruitós de Bages, Catalonia, 08272
Pere Roura-Poch, MD, MPH, +34.93.693.00.40, proura@chv.cat
Carme Boix, RN
About this study
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.
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Diabetes expert patients programme
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes expert patients programmeBehavioural
Nine-weekly informative and educational sessions by a teaching patient who has experience on diabetes
| Study group | Role | What they receive |
|---|---|---|
| Diabetes expert patients programme | Experimental | Diabetes expert patients programme: Participate in a scheduled and standardized expert patients programme course Receives: Behavioral: Diabetes expert patients programme |
| No intervention | Placebo comparator | Don't participate in a scheduled and standardized expert patients programme course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycosylated hemoglobin A
Change in glycosylated hemoglobin A percentage level
Measured: At baseline, and at 8th and 14th months of follow-up
Secondary outcomes (2)
Health related quality of life
Change in scores from Diabetes quality of life questionnaire
Measured: At baseline, and at 8th and 14th months of follow-up
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.
Measured: 12 months before inclusion and 12 months after intervention ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionApr 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Catalan Institute of Health
- Responsible party
- Sponsor
- Investigators
- Carme Boix, RN, Principal investigator, Catalan Institute of HealthPere Roura-Poch, MD, MPH, Study director, Catalan Institute of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01898702
- Sponsor's protocol ID
- EPPD-2012-ICS
- Acronym
- EPPD-ICS
- Status last verified
- Jul 2013
- First submitted
- 10 Jul 2013
- Last updated
- 23 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expert Patients Programme Effectiveness on Diabetes Control. A Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01898702
- Acronym / sponsor ID
- EPPD-ICS / EPPD-2012-ICS
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Catalan Institute of Health
- Study start
- May 2013
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 12 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes expert patients programme | Experimental | Behavioral: Diabetes expert patients programmeDiabetes expert patients programme: Participate in a scheduled and standardized expert patients programme course |
| No intervention | Placebo comparator | –Don't participate in a scheduled and standardized expert patients programme course |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diabetes mellitus, Type 2
- Older than 18
Key exclusion criteria (7 listed)
- Dementia
- Psychosis
- Home nursing
- Mental disabled people
- Subjects unable to express themselves in Spanish or catalan languages
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetes expert patients programmeNine-weekly informative and educational sessions by a teaching patient who has experience on diabetes | Behavioural | Diabetes expert patients programme |
Primary outcome
Glycosylated hemoglobin A
Time frame: At baseline, and at 8th and 14th months of follow-up
Change in glycosylated hemoglobin A percentage level
2 secondary outcomes
Health related quality of life
Time frame: At baseline, and at 8th and 14th months of follow-up
Health services utilization
Time frame: 12 months before inclusion and 12 months after intervention ends
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carme Boix, RN principal investigator
Catalan Institute of Health
Pere Roura-Poch, MD, MPH study director
Catalan Institute of Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes expert patients programme in people with Diabetes Mellitus, Type 2, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pere Roura-Poch, MD, MPH (+34.93.693.00.40, proura@chv.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycosylated hemoglobin A (time frame: At baseline, and at 8th and 14th months of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2013.