Coaching of Diabetic Patients After Hospital Discharge (SORTIDIAB)

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: Type 2 Diabetes

Treatments: Behavioral: Coaching with coordinate care

Study type: Interventional

Funder types: Other

Identifiers

NCT01877213

P110602

2012-A00938-35 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

600 participants in 2 patient groups

Coaching with coordinate care

Experimental group

Description:

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

Treatment:

Behavioral: Coaching with coordinate care

Usual care

No Intervention group

Description:

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