Case Management - Active Telephone Support to Patients With COLD

Active Support to Patient With COLD

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

Study Overview

• Status: Unknown
• Conditions: COLD
• Intervention / Treatment: Behavioral: Lifestyle behavioral. Health plan, telephone support

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.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Roskilde, Denmark, 4000
    • Recruiting
    • Regional Research
    • Contact: Knud Rasmussen, MD DMSci; Phone Number: +45 60168891; Email: kra@regionsjaelland.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Only SF-36 and CAT
Active Comparator: Active; Lifestyle behavioral. Health plan, telephone support	Behavioral: Lifestyle behavioral. Health plan, telephone support; 'Lifestyle behavioral. Health plan, telephone support'

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Region Sjælland
• Collaborators: Health Navigator, Sweden
• Investigators: Principal Investigator: Knud Rasmussen, MD DMSci, Region of Zealand

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): October 1, 2015
• Study Completion (Anticipated): April 1, 2016

Study Registration Dates

• First Submitted: April 23, 2015
• First Submitted That Met QC Criteria: May 26, 2015
• First Posted (Estimate): May 29, 2015

Study Record Updates

• Last Update Posted (Estimate): May 29, 2015
• Last Update Submitted That Met QC Criteria: May 26, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: CM1