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Coaching of Diabetic Patients After Hospital Discharge (SORTIDIAB)

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ClinicalTrials.gov Identifier: NCT01877213
Recruitment Status : Recruiting
First Posted : June 13, 2013
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Coaching with coordinate care Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Coaching of Difficult Diabetic Patients by a Care Coordinating Team After Hospital Discharge
Study Start Date : June 2013
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Coaching with coordinate care
After discharge from hospital, patients randomized in the coaching group will be coached by a coordinator nurse.
Behavioral: Coaching with coordinate care
The coordinator nurse will manage ambulatory care with the patient's GP and participate to patient's education.

No Intervention: Usual care
After discharge from hospital, patients randomized in the no intervention group will be managed as usually.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Causes of rehospitalizations [ Time Frame: Up to 1 year ]
    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.

  2. Duration of rehospitalizations [ Time Frame: Up to 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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,
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01877213


Contacts
Contact: Philippe CHANSON, MD, PhD +33 1 45 21 37 08 philippe.chanson@bct.aphp.fr

Locations
France
Assistance Publique - Hôpitaux de Paris, Bicêtre Hospital Recruiting
Le Kremlin-bicetre, France, 94 275
Contact: Philippe CHANSON, MD, PhD    + 33 1 45 21 37 08    philippe.chanson@bct.aphp.fr   
Principal Investigator: Philippe CHANSON, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Philippe CHANSON, MD, PhD Assistance Publique Hôpitaux de Paris - Bicêtre Hospital

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01877213     History of Changes
Other Study ID Numbers: P110602
2012-A00938-35 ( Other Identifier: IRB number )
First Posted: June 13, 2013    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: April 2017

Keywords provided by Assistance Publique - Hôpitaux de Paris:
coaching
therapeutic education
hospital admission
quality improvement strategies
management program
nurse follow up
discharge planning
rehospitalization