Cardiomyopathy, DiabeticNCT03206294
Impact of Pharmacist in Cardiology Service
A study testing pharmacist assessment in people with Cardiomyopathy, Diabetic, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
The coverage of the diabetes is a multidisciplinary care, with practitioners' implication(hospital and liberal), and other medical and paramedical profession: doctor, pharmacist, male nurse, nutritionist, etc. In fact there is a real importance of link between hospital and general medecine outside. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiomyopathy, Diabetic
- What is being tested?
- pharmacist assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- 8 Mar 2017to 31 Dec 2018
- 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 type 2 patient hospitalized in cardiology service
- Hospitalization more than 24 hours
- with insuline or/and oral anti diabetic
Who cannot join
- diabètes type 1
- iatrogenic hyperglycaemia
- hospitalization for cardia angiography
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
Official title: Presence of a Clinical Pharmacist in a Cardiology Department: What Impact on the Management of Diabetic Patients Within Care Pathways? Example of Inpatient Cardiac Patients at GHPSJ
The coverage of the diabetes is a multidisciplinary care, with practitioners' implication(hospital and liberal), and other medical and paramedical profession: doctor, pharmacist, male nurse, nutritionist, etc. In fact there is a real importance of link between hospital and general medecine outside. That's why the pharmacist's presence during the hospitalization seems to be a good alternative to make the link between hospital and the outside pharmacist where patient take his treatment.
Hospital pharmacis proceed to a treatment conciliation at the entrance and at discharge.
By this conciliation the aim of the study is to show and quantify the impact of pharmacist presence on therapeutic target .
- Conditions
- Cardiomyopathy, Diabetic
- Being tested
- pharmacist assessment
- Medical subject headings
- Diabetic Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pharmacist assessmentOther
St Joseph Hospital pharmacist assess every diabetic patient hospitalized in cardiology service in term of antidiabetic treatment during the hospitalization
| Study group | Role | What they receive |
|---|---|---|
| pharmacist assessment intervention group | Other | St Joseph Hospital pharmacist assess every diabetic patient hospitalized in cardiology service in term of antidiabetic treatment during the hospitalization Receives: Other: pharmacist assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of biological test glycosylated haemoglobin evolution between the entrance and discharge
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start8 Mar 2017
- Primary completion28 Apr 2017
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiomyopathy, DiabeticStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Romain CADOR, MD, Principal investigator, GHPSJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03206294
- Sponsor's protocol ID
- PhCardiab
- Status last verified
- Aug 2018
- First submitted
- 29 Jun 2017
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presence of a Clinical Pharmacist in a Cardiology Department: What Impact on the Management of Diabetic Patients Within Care Pathways? Example of Inpatient Cardiac Patients at GHPSJ
- ClinicalTrials.gov ID
- NCT03206294
- Acronym / sponsor ID
- PhCardiab
- Conditions
- Cardiomyopathy, Diabetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 8 Mar 2017 (actual)
- Primary completion
- 28 Apr 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 2 Jul 2017 (actual)
- 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 coverage of the diabetes is a multidisciplinary care, with practitioners' implication(hospital and liberal), and other medical and paramedical profession: doctor, pharmacist, male nurse, nutritionist, etc. In fact there is a real importance of link between hospital and general medecine outside. That's why the pharmacist's presence during the hospitalization seems to be a good alternative to make the link between hospital and the outside pharmacist where patient take his treatment.
Hospital pharmacis proceed to a treatment conciliation at the entrance and at discharge.
By this conciliation the aim of the study is to show and quantify the impact of pharmacist presence on therapeutic target .
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pharmacist assessment intervention group | Other | Other: pharmacist assessmentSt Joseph Hospital pharmacist assess every diabetic patient hospitalized in cardiology service in term of antidiabetic treatment during the hospitalization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diabetes type 2 patient hospitalized in cardiology service
- Hospitalization more than 24 hours
- with insuline or/and oral anti diabetic
Key exclusion criteria (3 listed)
- diabètes type 1
- iatrogenic hyperglycaemia
- hospitalization for cardia angiography
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 |
|---|---|---|
| pharmacist assessmentSt Joseph Hospital pharmacist assess every diabetic patient hospitalized in cardiology service in term of antidiabetic treatment during the hospitalization | Other | pharmacist assessment intervention group |
Primary outcome
Measurement of biological test glycosylated haemoglobin evolution between the entrance and discharge
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Individual participant dataSharing planned: No
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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.
Romain CADOR, MD principal investigator
GHPSJ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pharmacist assessment in people with Cardiomyopathy, Diabetic, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of biological test glycosylated haemoglobin evolution between the entrance and discharge (time frame: 5 days). 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 4 Feb 2019.