- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02583555
Case Management Study to Reduce Health Care Utilization for Frequent Hospital Care Users
Randomised Case Management Study to Reduce Health Care Utilization for Frequent Hospital Care Users
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants are identified by administrative data and a model predicting high risk of future healthcare utilization. Participants are invited to the study by mail. After informed consent participants are randomized to either active treatment or control 3:1. Active patients have an in depth interview with a specially trained nurse. Further counselling by telephone weekly for 6-9 months.
Quality of Life is measured by SF-36 every 3 months for one year both in active participants and in controls.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Knud Rasmussen, MD DMSci
- Phone Number: +45 60168891
- Email: kra@regionsjaelland.dk
Study Contact Backup
- Name: Ellen B Zacho, Chief Consul
- Phone Number: + 45 24835717
- Email: ellenz@regionsjaelland.dk
Study Locations
-
-
-
Roskilde, Denmark, 4000
- Regional Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient > 18 years
- Recent history of contact with hospital
- Anticipated sustained high visit frequency
Exclusion Criteria:
- Dementia (ICD10: F00-F03 or F051)
- Psychoses (ICD10: F20-F29)
- Drug abuse (ICD10: F10-F19)
- Metastases (ICD10: C77-C80)
- Hearing impairment or language difficulties
- Life expectancy < 1 year No telephone
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Active patient support
Interview followed by frequent telephone support Questionnaire every 3 months
|
Interview followed by telephone support
|
No Intervention: Controls
Questionnaire every 3 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life reported by the participants with use of Short Form 36
Time Frame: Questionaire Short Form-36 Every 3 months for one year
|
Questionaire Short Form-36 Every 3 months for one year
|
|
Health Care Utilization - Admissions to and days in hospital
Time Frame: One year
|
The use of different health care systems will be recorded
|
One year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Knud Rasmussen, MD DMSci, Research Consultant
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SJ-499
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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