Coaching of Diabetic Patients After Hospital Discharge

NCT ID: NCT01877213

Last Updated: 2017-05-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2018-06-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Coaching with coordinate care

After discharge from hospital, patients randomized in the coaching group will be coached by a coordinator nurse.

Group Type: EXPERIMENTAL

Coaching with coordinate care

Intervention Type: BEHAVIORAL

The coordinator nurse will manage ambulatory care with the patient's GP and participate to patient's education.

Usual care

After discharge from hospital, patients randomized in the no intervention group will be managed as usually.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Coaching with coordinate care

The coordinator nurse will manage ambulatory care with the patient's GP and participate to patient's education.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe CHANSON, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique Hôpitaux de Paris - Bicêtre Hospital

Locations

Assistance Publique - Hôpitaux de Paris, Bicêtre Hospital

Le Kremlin-Bicêtre, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Philippe CHANSON, MD, PhD

Role: CONTACT

philippe.chanson@bct.aphp.fr

+33 1 45 21 37 08

Facility Contacts

Philippe CHANSON, MD, PhD

Role: primary

philippe.chanson@bct.aphp.fr

+ 33 1 45 21 37 08

Other Identifiers

2012-A00938-35

Identifier Type: OTHER

Identifier Source: secondary_id

P110602

Identifier Type: -

Identifier Source: org_study_id