Acute Combined Care for Seniors in Southern Denmark | NCT02422849

Studies
Acute Combined Care for Seniors in Southern Denmark

NCT02422849

Sponsor

University of Southern Denmark

Status

Completed

Last Update Posted

Feb 17, 2016Estimated

Enrollment

131Actual

Phase

Not Applicable

Conditions

Acute Medical Conditions

Interventions

hospital specialist
General Practitioner

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Feb 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Mar 27, 2015

First Submission Date that Met QC Criteria

Apr 16, 2015

First Posted Date

Apr 21, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2016

Last Update Posted Date

Feb 17, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Christian Backer Mogensen, associate professor, University of Southern DenmarkPrincipal Investigator

Lead Sponsor

University of Southern DenmarkOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

the elderly population (+ 65 years) is increasing. Acute medical conditions often leads to hospital admissions in this age group. However hospital admission is linked to adverse events. like confusion, medication errors or new infections.

the ACCESS project aims to examine alternatives to acute admissions for senior medical patients.

the aims are:

How many patients will be admitted to hospital due to acute medical conditions if cared for by their own General Practitioner (GP) versus a hospital intern specialist ?
how many patients will be admitted to hospital due to acute medical conditions if cared for by acute team in their home versus in specialised care centres ?

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

131Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
own GP	Other	The patient is cared for by own General Practitioner in the acute stage	Other: General Practitioner
Hospital specialist	Other	The patient is cared for by a hospital specialist in the acute stage	Other: hospital specialist

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hospital specialist	Other		Hospital specialist
General Practitioner

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of participants with hospital admission		3 months after inclusion

Secondary Outcomes

Measure	Description	Time Frame
change from baseline in De Morton Mobility Index (DEMMI)		3 months after inclusion
change from baseline in quality of life (EQ5D scale)		3 months after inclusion

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

acute medical condition requiring immediate intervention.

Exclusion Criteria:

GP not available next days
absolutely admission requiring condition
no informed consent obtainable
nursing home resident
inclusion in ACCESS within the last 3 months
home care capacity limit reached

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aabenraa Sygehus Emergency Department		Aabenraa		6200	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D058005	General Practitioners

Ancestor Terms

ID	Term
D010820	Physicians
D006282	Health Personnel
D005159	Health Care Facilities Workforce and Services

Browse Leaves

Not provided

Browse Branches

Not provided