Case Management - Active Telephone Support to Patients With COLD

NCT ID: NCT02457533

Last Updated: 2015-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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COLD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control

Only SF-36 and CAT

Group Type NO_INTERVENTION

No interventions assigned to this group

Active

Lifestyle behavioral. Health plan, telephone support

Group Type ACTIVE_COMPARATOR

Lifestyle behavioral. Health plan, telephone support

Intervention Type BEHAVIORAL

'Lifestyle behavioral. Health plan, telephone support'

Interventions

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Lifestyle behavioral. Health plan, telephone support

'Lifestyle behavioral. Health plan, telephone support'

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Health Navigator, Sweden

UNKNOWN

Sponsor Role collaborator

Region Sjælland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Knud Rasmussen, MD DMSci

Role: PRINCIPAL_INVESTIGATOR

Region of Zealand

Locations

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Regional Research

Roskilde, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Knud Rasmussen, MD DMSci

Role: CONTACT

Phone: +45 60168891

Email: [email protected]

Mahad Huniche, Director

Role: CONTACT

Phone: +45 51200187

Email: [email protected]

Facility Contacts

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Knud Rasmussen, MD DMSci

Role: primary

Other Identifiers

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CM1

Identifier Type: -

Identifier Source: org_study_id