Case Management - Active Telephone Support to Patients Wi... | NCT02457533

Studies
Case Management - Active Telephone Support to Patients With COLD

NCT02457533

Sponsor

Region Sjælland

Status

Unknown status

Last Update Posted

May 29, 2015Estimated

Enrollment

400Estimated

Phase

Not Applicable

Conditions

COLD

Interventions

Lifestyle behavioral. Health plan, telephone support

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

May 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

Oct 2015Estimated

Completion Date

Apr 2016Estimated

First Submitted Date

Apr 23, 2015

First Submission Date that Met QC Criteria

May 26, 2015

First Posted Date

May 29, 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

May 26, 2015

Last Update Posted Date

May 29, 2015Estimated

Name	Class
Health Navigator, Sweden	UNKNOWN

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

To investigate the effects of patient counseling by telephone on Quality of Life and the use of Health care system.

Detailed Description

By analyzing patient data, patients with risk of high consumption of the Health system are identified.

These patients are invited to take part in the study. If the patient accept the invitation, oral and written information of the study is given. If the patient give informed consent to participate, the inclusion and exclusion criteria and the patient record are examined.

If the patient meet the criteria the patient is randomized to active treatment or control 1:1.

Patient in the Intervention Group have a in depth interview of Health and social status and possible interventions are planned. Following that, the patient is contacted by telephone on weekly intervals for 6 to 9 months.

Patients in both Groups fill out questionaire Short-Form Health Survey-36 (SF-36) and COPD Assessment Test (COPD) and the consumption of Health care is monitored.

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

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention	Only SF-36 and CAT
Active	Active Comparator	Lifestyle behavioral. Health plan, telephone support	Behavioral: Lifestyle behavioral. Health plan, telephone support

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lifestyle behavioral. Health plan, telephone support	Behavioral	'Lifestyle behavioral. Health plan, telephone support'	Active

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality of Life questionnaire SF-36 (Short-Form Health Survey)		Participants will be followed an expected avarage of 6 months

Secondary Outcomes

Measure	Description	Time Frame
Analysis of patients use of Health Care system		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient living in The Zealand Region.
A COLD-related contact with hospital with-in 6 months.
Predicted to be in high risk of new hospital admission.

Exclusion Criteria:

Dementia.
Psychosis.
Drug-addiction.
Cancer with metastasis.
Terminal illness.
Language difficulties demanding translator.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Knud Rasmussen, MD DMSci	Contact	+45 60168891		kra@regionsjaelland.dk
Mahad Huniche, Director	Contact	+45 51200187		mahu@regionsjaelland.dk

Overall Officials

Name	Affiliation	Role
Knud Rasmussen, MD DMSci	Region of Zealand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Regional Research	Recruiting	Roskilde		4000	Denmark