Case Management - Active Telephone Support to Patients With COLD

COLD Clinical Trial

Official title:

Active Support to Patient With COLD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02457533
• Other study ID #: CM1
• Status: Recruiting
• Phase: N/A
• First received: April 23, 2015
• Last updated: May 26, 2015
• Start date: April 2015
• Est. completion date: April 2016

Study information

• Verified date: May 2015
• Source: Region Sjælland
• Contact: Knud Rasmussen, MD DMSci
• Phone: +45 60168891
• Email: kra[@]regionsjaelland.dk
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: April 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• COLD

Intervention

Behavioral:
• Lifestyle behavioral. Health plan, telephone support
'Lifestyle behavioral. Health plan, telephone support'

Locations

Country	Name	City	State
Denmark	Regional Research	Roskilde

Sponsors (2)

Lead Sponsor	Collaborator
Region Sjælland	Health Navigator, Sweden

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life questionnaire SF-36 (Short-Form Health Survey)		Participants will be followed an expected avarage of 6 months	No
Secondary	Analysis of patients use of Health Care system		1 year	No