Type 2 DiabetesSORTIDIABNCT01877213
Coaching of Diabetic Patients After Hospital Discharge
A study testing Coaching with coordinate care in people with Type 2 Diabetes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
One third of the costs of medical care for people with diabetes are related to hospitalization." Difficult" diabetic patient, i.e. those with very high HbA1c, patients > 75y, those with diabetic foot ulcers, or those with a recent cardiovascular event have a high rate of readmission when discharged at home after an… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Coaching with coordinate care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2013to Jun 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
- type 1 or type 2 diabetes AND AT LEAST ONE of the following criteria:
- admission for more than 5 days
- unplanned admission
- at least one urgent care/emergency room visit in the 6 previous months, whatever its cause
- HbA1c > 10% on admission
- cardiovascular event in the previous year : cardiac failure, myocardial infarction, coronary or peripheral revascularization procedure, stage IV peripheral arteriopathy, stroke.
- occurence during the previous year of a foot lesion requiring an admission or lasting more than one month (foot lesion risk stage 3)
Who cannot join
- patients with one of the following co-morbidity: cancer in active phase of treatment, Parkinson's disease treated, severe chronic respiratory failure,
- refusal of signing the consent,
- patients non affiliated to Social Security,
- pregnant women,
- people who do not understand French (except if accompanied by somebody able to translate),
- renal dialysis,
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- patients aged less than 18 years,
- patients already in a similar type of trial
- the arisen of a pregnancy or a cancer will cause the stop of the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance Publique - Hôpitaux de Paris, Bicêtre Hospital
Le Kremlin-Bicêtre, 94 275
Philippe CHANSON, MD, PhD, + 33 1 45 21 37 08, philippe.chanson@bct.aphp.fr
Philippe CHANSON, MD, PhD
About this study
Official title: Coaching of Difficult Diabetic Patients by a Care Coordinating Team After Hospital Discharge
One third of the costs of medical care for people with diabetes are related to hospitalization." Difficult" diabetic patient, i.e. those with very high HbA1c, patients > 75y, those with diabetic foot ulcers, or those with a recent cardiovascular event have a high rate of readmission when discharged at home after an initial hospitalization related to diabetes or its complications. The objective of the study is to test if a coaching with a care coordinating team after hospital discharge would decrease diabetes-related rehospitalization rate compared with usual care.
Read the detailed description
Patients with type 1 (T1D) or type 2 diabetes (T2D) hospitalized (>24h) and presenting at least a risk factor for readmission after discharge at home, will be randomized, at time of discharge, between 2 groups: an "intervention" group and a control group (usual management). Intervention will consist in optimized organization of discharge at home followed by a ambulatory individualized coaching by a nurse including an initial situation assessment, a consultation meeting with the patient's GP in order to propose a Health Personalized Plan, then a follow up program with a face to face session each trimester in order to remind the objectives, to assess compliance to the plan, to evaluate difficulties encountered and to help to find solutions. Final data collection will be done in both groups by questioning the patient's general practitioner (GP) and by collecting data on potential hospitalization. Expected duration : 3 years. Readmission rate, duration and causes of hospitalization will be compared between both groups. Impact of the results : Reduction of costs, improved use of hospital specialized resources.
- Conditions
- Type 2 Diabetes
- Being tested
- Coaching with coordinate care
- Keywords
- coaching, therapeutic education, hospital admission, quality improvement strategies, management program, nurse follow up, discharge planning, rehospitalization
- 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.
Coaching with coordinate careBehavioural
The coordinator nurse will manage ambulatory care with the patient's GP and participate to patient's education.
| Study group | Role | What they receive |
|---|---|---|
| Coaching with coordinate care | Experimental | After discharge from hospital, patients randomized in the coaching group will be coached by a coordinator nurse. Receives: Behavioral: Coaching with coordinate care |
| Usual care | No intervention | After discharge from hospital, patients randomized in the no intervention group will be managed as usually. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes-related readmissions
Recording of all readmissions and analysis of files and reports for determining if this readmission was related to diabetes or not.
Measured: Up to 1 year
Secondary outcomes (2)
Causes of rehospitalizations
Each admission to hospital (type of department, duration, direct admission or via Emergency room…) will be recorded. All efforts will be made to record the cause of hospitalization.
Measured: Up to 1 year
Duration of rehospitalizations
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe CHANSON, MD, PhD, Principal investigator, Assistance Publique Hôpitaux de Paris - Bicêtre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01877213
- Sponsor's protocol ID
- P110602
- Other IDs
- 2012-A00938-35
- Acronym
- SORTIDIAB
- Status last verified
- Apr 2017
- First submitted
- 11 Jun 2013
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coaching of Difficult Diabetic Patients by a Care Coordinating Team After Hospital Discharge
- ClinicalTrials.gov ID
- NCT01877213
- Acronym / sponsor ID
- SORTIDIAB / P110602
- Conditions
- Type 2 Diabetes
- Keywords
- coaching, therapeutic education, hospital admission, quality improvement strategies, management program, nurse follow up, discharge planning, rehospitalization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 13 Jun 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.
One third of the costs of medical care for people with diabetes are related to hospitalization." Difficult" diabetic patient, i.e. those with very high HbA1c, patients > 75y, those with diabetic foot ulcers, or those with a recent cardiovascular event have a high rate of readmission when discharged at home after an initial hospitalization related to diabetes or its complications. The objective of the study is to test if a coaching with a care coordinating team after hospital discharge would decrease diabetes-related rehospitalization rate compared with usual care.
Detailed description
Patients with type 1 (T1D) or type 2 diabetes (T2D) hospitalized (>24h) and presenting at least a risk factor for readmission after discharge at home, will be randomized, at time of discharge, between 2 groups: an "intervention" group and a control group (usual management). Intervention will consist in optimized organization of discharge at home followed by a ambulatory individualized coaching by a nurse including an initial situation assessment, a consultation meeting with the patient's GP in order to propose a Health Personalized Plan, then a follow up program with a face to face session each trimester in order to remind the objectives, to assess compliance to the plan, to evaluate difficulties encountered and to help to find solutions. Final data collection will be done in both groups by questioning the patient's general practitioner (GP) and by collecting data on potential hospitalization. Expected duration : 3 years. Readmission rate, duration and causes of hospitalization will be compared between both groups. Impact of the results : Reduction of costs, improved use of hospital specialized resources.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coaching with coordinate care | Experimental | Behavioral: Coaching with coordinate careAfter discharge from hospital, patients randomized in the coaching group will be coached by a coordinator nurse. |
| Usual care | No intervention | –After discharge from hospital, patients randomized in the no intervention group will be managed as usually. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- type 1 or type 2 diabetes AND AT LEAST ONE of the following criteria:
Key exclusion criteria (9 listed)
- patients with one of the following co-morbidity: cancer in active phase of treatment, Parkinson's disease treated, severe chronic respiratory failure,
- refusal of signing the consent,
- patients non affiliated to Social Security,
- pregnant women,
- people who do not understand French (except if accompanied by somebody able to translate),
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 |
|---|---|---|
| Coaching with coordinate careThe coordinator nurse will manage ambulatory care with the patient's GP and participate to patient's education. | Behavioural | Coaching with coordinate care |
Primary outcome
Diabetes-related readmissions
Time frame: Up to 1 year
Recording of all readmissions and analysis of files and reports for determining if this readmission was related to diabetes or not.
2 secondary outcomes
Causes of rehospitalizations
Time frame: Up to 1 year
Duration of rehospitalizations
Time frame: Up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
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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.
Philippe CHANSON, MD, PhD principal investigator
Assistance Publique Hôpitaux de Paris - Bicêtre Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coaching with coordinate care in people with Type 2 Diabetes, run by Assistance Publique - Hôpitaux de Paris 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 7 inclusion and 9 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 3 May 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe CHANSON, MD, PhD (+33 1 45 21 37 08, philippe.chanson@bct.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes-related readmissions (time frame: Up to 1 year). 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 3 May 2017.