Quality of LifeNCT02583555
Case Management Study to Reduce Health Care Utilization for Frequent Hospital Care Users
A study testing Interview followed by frequent telephone support in people with Quality of Life, run by Region Sjælland at 1 site in Denmark.
Trial summary
The purpose of this study is to identify persons with high risk of frequent hospital admissions and by counselling by one in depth interview followed by frequent telephone contacts improve their quality of life and reduce their healthcare utilization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life
- What is being tested?
- Interview followed by frequent telephone support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2015to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient > 18 years
- Recent history of contact with hospital
- Anticipated sustained high visit frequency
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Case Management Study to Reduce Health Care Utilization for Frequent Hospital Care Users
The purpose of this study is to identify persons with high risk of frequent hospital admissions and by counselling by one in depth interview followed by frequent telephone contacts improve their quality of life and reduce their healthcare utilization.
Read the 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.
- Conditions
- Quality of Life
- Being tested
- Interview followed by frequent telephone support
- Keywords
- Quality of Life, Health Care Utilization
- Medical subject headings
- Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interview followed by frequent telephone supportBehavioural
Interview followed by telephone support
| Study group | Role | What they receive |
|---|---|---|
| Active patient support | Active comparator | Interview followed by frequent telephone support Questionnaire every 3 months Receives: Behavioral: Interview followed by frequent telephone support |
| Controls | No intervention | Questionnaire every 3 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life reported by the participants with use of Short Form 36
Measured: Questionaire Short Form-36 Every 3 months for one year
Health Care Utilization - Admissions to and days in hospital
The use of different health care systems will be recorded
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2016 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Sjælland
- Sponsor type
- University, hospital or other
- Collaborators
- Health Navigator
- Responsible party
- Principal investigator, Knud Rasmussen, MD, DMSci, Region Sjælland
- Investigators
- Knud Rasmussen, MD DMSci, Principal investigator, Research Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583555
- Sponsor's protocol ID
- SJ-499
- Status last verified
- Oct 2015
- First submitted
- 20 Oct 2015
- Last updated
- 22 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Case Management Study to Reduce Health Care Utilization for Frequent Hospital Care Users
- ClinicalTrials.gov ID
- NCT02583555
- Acronym / sponsor ID
- SJ-499
- Conditions
- Quality of Life
- Keywords
- Quality of Life, Health Care Utilization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Region SjællandUniversity, hospital or other
- Collaborators
- Health Navigator
- Study start
- Nov 2015
- Primary completion
- Nov 2016 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 22 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to identify persons with high risk of frequent hospital admissions and by counselling by one in depth interview followed by frequent telephone contacts improve their quality of life and reduce their healthcare utilization.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active patient support | Active comparator | Behavioral: Interview followed by frequent telephone supportInterview followed by frequent telephone support Questionnaire every 3 months |
| Controls | No intervention | –Questionnaire every 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient > 18 years
- Recent history of contact with hospital
- Anticipated sustained high visit frequency
Key exclusion criteria (6 listed)
- Dementia (ICD10: F00-F03 or F051)
- Psychoses (ICD10: F20-F29)
- Drug abuse (ICD10: F10-F19)
- Metastases (ICD10: C77-C80)
- Hearing impairment or language difficulties
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interview followed by frequent telephone supportInterview followed by telephone support | Behavioural | Active patient support |
Primary outcome
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
Health Care Utilization - Admissions to and days in hospital
Time frame: One year
The use of different health care systems will be recorded
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Knud Rasmussen, MD DMSci principal investigator
Research Consultant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interview followed by frequent telephone support in people with Quality of Life, run by Region Sjælland at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Knud Rasmussen, MD DMSci (+45 60168891, kra@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2015.