NCT01877213

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2013

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

May 3, 2017

Status Verified

April 1, 2017

Enrollment Period

4 years

First QC Date

June 11, 2013

Last Update Submit

May 2, 2017

Conditions

Type 2 Diabetes

Keywords

coachingtherapeutic educationhospital admissionquality improvement strategiesmanagement programnurse follow updischarge planningrehospitalization

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Causes of rehospitalizations

    Up to 1 year

  • Duration of rehospitalizations

    Up to 1 year

Study Arms (2)

Coaching with coordinate care

EXPERIMENTAL

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

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.

Interventions

Coaching with coordinate careBEHAVIORAL

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

Coaching with coordinate care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique - Hôpitaux de Paris, Bicêtre Hospital

Le Kremlin-Bicêtre, 94 275, France

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Philippe CHANSON, MD, PhD

    Assistance Publique Hôpitaux de Paris - Bicêtre Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe CHANSON, MD, PhD

CONTACT

+33 1 45 21 37 08philippe.chanson@bct.aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2013

First Posted

June 13, 2013

Study Start

June 1, 2013

Primary Completion

June 1, 2017

Study Completion

June 1, 2018

Last Updated

May 3, 2017

Record last verified: 2017-04

Locations

FR(1)