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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02457533
Other study ID # CM1
Secondary ID
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


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
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