Coaching of Diabetic Patients After Hospital Discharge

Type 2 Diabetes Clinical Trial

— SORTIDIAB  

Official title:

Coaching of Difficult Diabetic Patients by a Care Coordinating Team After Hospital Discharge

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01877213
• Other study ID #: P110602
• Secondary ID: 2012-A00938-35
• Status: Recruiting
• Phase: N/A
• First received: June 11, 2013
• Last updated: May 2, 2017
• Start date: June 2013
• Est. completion date: June 2018

Study information

• Verified date: April 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Philippe CHANSON, MD, PhD
• Phone: +33 1 45 21 37 08
• Email: philippe.chanson[@]bct.aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: June 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Behavioral:
• Coaching with coordinate care
The coordinator nurse will manage ambulatory care with the patient's GP and participate to patient's education.

Locations

Country	Name	City	State
France	Assistance Publique - Hôpitaux de Paris, Bicêtre Hospital	Le Kremlin-bicetre

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diabetes-related readmissions	Recording of all readmissions and analysis of files and reports for determining if this readmission was related to diabetes or not.	Up to 1 year
Secondary	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.	Up to 1 year
Secondary	Duration of rehospitalizations		Up to 1 year