HomelessnessBCNCT02649595
Bridge Copenhagen - Respite Care for Homeless People
A study testing Red Cross Respite care in people with Homelessness and Respite Care, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The aim of this study is to determine the effect of a two week respite program (Red Cross) for homeless people just discharged from hospitals in the capital region of Denmark. The study is a randomized controlled trial and an economic evaluation. The intervention is a 2 week stay at a Red Cross respite care center. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Homelessness, Respite Care
- What is being tested?
- Red Cross Respite care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2014to Jun 2016
- 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
- Homeless or functional homeless who is self-reliant and not ill enough to stay in the hospital but to sick or frail to live on the streets.
Who cannot join
- People who has cognitive problems understanding the information about the study.
- People who does not speak and understands at least one of the following languages: Danish, english, polish, romanian, german and french.
- People who have planned to leave Denmark within 6 month of inclusion in the study.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Clinical research Centre, Amager Hvidovre hospital
Hvidovre, 2650
About this study
The aim of this study is to determine the effect of a two week respite program (Red Cross) for homeless people just discharged from hospitals in the capital region of Denmark.
The study is a randomized controlled trial and an economic evaluation. The intervention is a 2 week stay at a Red Cross respite care center. The intervention is intended for homeless people or functional homeless, who has been admitted to hospital and received standard medical care and treatment at the hospital. Under normal circumstances the homeless patients would be discharged to live on the street and receive care from programs in the municipalities. The respite center offers standard nursing care, rest with a place to sleep, food and help dealing with social problems such as economy and housing. The respite care center is led by a nurse who is represented during daytime from Monday to Friday and besides that, volunteers are used as staff.
Read more
The control group is receiving usual care and is discharged to the street and the usual communal programs.
The study examines whether a 2 week stay is cost effective and whether it can improve the health related quality of live (HRQoL). The hypothesis is that a respite care stay will result in a 25 % reduction in health care costs and increase the HRQoL.
Read the detailed description
The study is a randomized controlled trial with an economic evaluation of a Red Cross respite care stay for homeless people, who have just been discharged from hospital in the capitol region of Denmark.
The effect of a respite care stay for homeless people has never been investigated in Denmark.
Intervention:
The intervention consists of a 2 week stay at a Red Cross respite center. The intervention is intended for homeless or the functional homeless who is not ill enough to stay in the hospital, but to sick or frail to live on the streets. The homeless patients have received the standard medical care and treatment at the hospital and would under normal circumstances be discharged to live on the street and receive care from programs in the municipalities. The respite care center offers a free stay with a place to sleep, food three times a day, help with nursing tasks and help dealing with social problems such as economy and housing. The place is led by a nurse who is working during daytime from Monday to Friday and besides that, volunteers are used as staff.
The control group is discharged from hospital to the street and the usual programs in the municipalities.
Outcome:
The primary outcome is the difference in health economic costs measured in DKK over a period of 3 months. The secondary outcomes are difference in Quality adjusted life-years (QALY) over a period of 3 month, health economic costs over a period of 6 months, difference in elective health care costs, difference in acute health care costs and difference in social costs.
Quality adjusted life-years can be calculated by using the EQ-5D-5l questionnaire that measures health related quality of life (HRQoL). The answers from the questionnaire can be converted to an index value and is used to calculate QALY's. Quality Adjusted Life-Years is also used as the outcome measure of the cost-utility analysis (CUA).
Data collection:
Data about health economic costs for the CUA is going to be extracted from the National Patient Registry, Civil Registration System, The National Health Insurance Service Registry, communal databases and from the operational costs of the respite center.
HRQoL is measured by using the questionnaire EQ-5D-5L. All participants answer the questionnaire at baseline at the hospital before randomization, then 2 weeks later and again 3 month from baseline. The answers from the questionnaire can be converted to an index value and is used to calculate Quality Adjusted Life-years (QALY). In this way it can be investigated whether there has been an increase or decrease in QALY's and clarify if there is any difference between the two groups.
Variables:
There will be collected information on following variables, demographics, mental illness (reported from latest hospital admission by the social nurses), physical health by Charlson score, self-reported substance abuse and duration of homelessness. Moreover records from the Red Cross respite center will be reviewed and information about what the individuals received help with is registered.
Analyses:
Regarding the primary outcome, an analysis of variance is performed to determine the difference between the costs of the intervention and control group. Furthermore analysis of variance is performed to compare the development in QALY's in both groups. Both the analysis for the primary and secondary outcome is performed as an intention to treat analysis.
The economic evaluation is performed like a CUA. Results from the CUA will be presented as an incremental cost-effectiveness ratio (ICER).
In case of a skew distribution between intervention and control group in possible confounders like the variables mentioned above, the analysis will also be adjusted for these.
Sample size:
With a power of 80 %, p- values=0,05, an estimated health economic costs in the control group on 100.000 DKK and a standard deviation of 39.243 DKK. To detect a difference between the groups of minimum 25.000 DKK, a total of 96 participants are needed in the study. That includes 20 % drop-out for data regarding the questionnaires.
- Conditions
- Homelessness, Respite Care
- Being tested
- Red Cross Respite care
- Keywords
- Homeless, Homelessness, Respite care, EQ-5D, Quality of life questionnaire, Economic evaluation, Cost-utility analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red Cross Respite careOther
Also called Omsorgscenter Thorsgade
See detailed description.
| Study group | Role | What they receive |
|---|---|---|
| Red Cross respite care | Other | A 2 week free stay at a Red Cross respite center after hospitalization. Receives: Other: Red Cross Respite care |
| Streets/communal programmes | No intervention | Homeless being discharged from hospital to the streets and communal programmes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health economic costs
All costs related to health extracted from the National Patient Registry, Civil Registration System, The National Health Insurance Service Registry, databases from the municipality and from information about costs from the Red Cross respite center. Hereby it can be investigatet if there is any difference in health economic costs between the two groups.
Measured: 3 months
Secondary outcomes (5)
Health Related Quality of Life (EQ-5D-5L)
HRQoL is measured by using the questionnaire EQ-5D-5L. All participants answer the questionnaire at baseline at the hospital, 2 weeks later and again 3 month from baseline. The answers from the questionnaire can be converted to an index value and is used to calculate Quality Adjusted Life-years (QALY). In this way it can be investigated if there is difference in QALY's between the two groups.
Measured: 3 months
Health economic costs
All costs related to health extracted from the National Patient Registry, Civil Registration System, The National Health Insurance Service Registry, databases from the municipality and from information about the budget of the Red Cross respite center. Hereby it can be investigatet if there is any difference in health economic costs between the two groups.
Measured: 6 months
Elective health care costs
Data on elective health costs will be retrieved from the National Patient Registry, The National Health Insurance Service Registry and databases from the municipalities to see if there is a difference between the control group and the intervention group
Measured: 3 and 6 months
Acute health care costs
Data on acute health care costs will be retrieved from the National Patient Registry, The National Health Insurance Service Registry and databases from the municipalities to see if there is a difference between the control group and the intervention group
Measured: 3 and 6 months
Social costs
Data on social costs will be retrieved from the National Patient Registry, The National Health Insurance Service Registry and databases from the municipalities to see if there is a difference between the control group and the intervention group
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startApr 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HomelessnessStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Red Cross Copenhagen, Region Capital Denmark, Copenhagen Municipality, Denmark
- Responsible party
- Principal investigator, Ove Andersen, Hvidovre University Hospital
- Investigators
- Ove Andersen, PhD, MD, Principal investigator, Clinical Research Centre, University Hospital of Copenhagen, Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02649595
- Sponsor's protocol ID
- 15000708
- Other IDs
- 04173 AHH-2015-090
- Acronym
- BC
- Status last verified
- May 2018
- First submitted
- 6 Jan 2016
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bring C, Kruse M, Ankarfeldt MZ, Brunes N, Pedersen M, Petersen J, Andersen O. Post-hospital medical respite care for homeless people in Denmark: a randomized controlled trial and cost-utility analysis. BMC Health Serv Res. 2020 Jun 5;20(1):508. doi: 10.1186/s12913-020-05358-4.
PubMed 32503545
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bridge Copenhagen - Respite Care for Homeless People
- ClinicalTrials.gov ID
- NCT02649595
- Acronym / sponsor ID
- BC / 15000708
- Conditions
- Homelessness, Respite Care
- Keywords
- Homeless, Homelessness, Respite care, EQ-5D, Quality of life questionnaire, Economic evaluation, Cost-utility analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Red Cross Copenhagen, Region Capital Denmark, Copenhagen Municipality, Denmark
- Study start
- Apr 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 7 Jan 2016 (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 aim of this study is to determine the effect of a two week respite program (Red Cross) for homeless people just discharged from hospitals in the capital region of Denmark.
The study is a randomized controlled trial and an economic evaluation. The intervention is a 2 week stay at a Red Cross respite care center. The intervention is intended for homeless people or functional homeless, who has been admitted to hospital and received standard medical care and treatment at the hospital. Under normal circumstances the homeless patients would be discharged to live on the street and receive care from programs in the municipalities. The respite center offers standard nursing care, rest with a place to sleep, food and help dealing with social problems such as economy and housing. The respite care center is led by a nurse who is represented during daytime from Monday to Friday and besides that, volunteers are used as staff.
The control group is receiving usual care and is discharged to the street and the usual communal programs.
The study examines whether a 2 week stay is cost effective and whether it can improve the health related quality of live (HRQoL). The hypothesis is that a respite care stay will result in a 25 % reduction in health care costs and increase the HRQoL.
Detailed description
The study is a randomized controlled trial with an economic evaluation of a Red Cross respite care stay for homeless people, who have just been discharged from hospital in the capitol region of Denmark.
The effect of a respite care stay for homeless people has never been investigated in Denmark.
Intervention:
The intervention consists of a 2 week stay at a Red Cross respite center. The intervention is intended for homeless or the functional homeless who is not ill enough to stay in the hospital, but to sick or frail to live on the streets. The homeless patients have received the standard medical care and treatment at the hospital and would under normal circumstances be discharged to live on the street and receive care from programs in the municipalities. The respite care center offers a free stay with a place to sleep, food three times a day, help with nursing tasks and help dealing with social problems such as economy and housing. The place is led by a nurse who is working during daytime from Monday to Friday and besides that, volunteers are used as staff.
The control group is discharged from hospital to the street and the usual programs in the municipalities.
Outcome:
The primary outcome is the difference in health economic costs measured in DKK over a period of 3 months. The secondary outcomes are difference in Quality adjusted life-years (QALY) over a period of 3 month, health economic costs over a period of 6 months, difference in elective health care costs, difference in acute health care costs and difference in social costs.
Quality adjusted life-years can be calculated by using the EQ-5D-5l questionnaire that measures health related quality of life (HRQoL). The answers from the questionnaire can be converted to an index value and is used to calculate QALY's. Quality Adjusted Life-Years is also used as the outcome measure of the cost-utility analysis (CUA).
Data collection:
Data about health economic costs for the CUA is going to be extracted from the National Patient Registry, Civil Registration System, The National Health Insurance Service Registry, communal databases and from the operational costs of the respite center.
HRQoL is measured by using the questionnaire EQ-5D-5L. All participants answer the questionnaire at baseline at the hospital before randomization, then 2 weeks later and again 3 month from baseline. The answers from the questionnaire can be converted to an index value and is used to calculate Quality Adjusted Life-years (QALY). In this way it can be investigated whether there has been an increase or decrease in QALY's and clarify if there is any difference between the two groups.
Variables:
There will be collected information on following variables, demographics, mental illness (reported from latest hospital admission by the social nurses), physical health by Charlson score, self-reported substance abuse and duration of homelessness. Moreover records from the Red Cross respite center will be reviewed and information about what the individuals received help with is registered.
Analyses:
Regarding the primary outcome, an analysis of variance is performed to determine the difference between the costs of the intervention and control group. Furthermore analysis of variance is performed to compare the development in QALY's in both groups. Both the analysis for the primary and secondary outcome is performed as an intention to treat analysis.
The economic evaluation is performed like a CUA. Results from the CUA will be presented as an incremental cost-effectiveness ratio (ICER).
In case of a skew distribution between intervention and control group in possible confounders like the variables mentioned above, the analysis will also be adjusted for these.
Sample size:
With a power of 80 %, p- values=0,05, an estimated health economic costs in the control group on 100.000 DKK and a standard deviation of 39.243 DKK. To detect a difference between the groups of minimum 25.000 DKK, a total of 96 participants are needed in the study. That includes 20 % drop-out for data regarding the questionnaires.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Red Cross respite care | Other | Other: Red Cross Respite careA 2 week free stay at a Red Cross respite center after hospitalization. |
| Streets/communal programmes | No intervention | –Homeless being discharged from hospital to the streets and communal programmes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Homeless or functional homeless who is self-reliant and not ill enough to stay in the hospital but to sick or frail to live on the streets.
Key exclusion criteria (3 listed)
- People who has cognitive problems understanding the information about the study.
- People who does not speak and understands at least one of the following languages: Danish, english, polish, romanian, german and french.
- People who have planned to leave Denmark within 6 month of inclusion in the study.
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 |
|---|---|---|
| Red Cross Respite careAlso: Omsorgscenter ThorsgadeSee detailed description. | Other | Red Cross respite care |
Primary outcome
Health economic costs
Time frame: 3 months
All costs related to health extracted from the National Patient Registry, Civil Registration System, The National Health Insurance Service Registry, databases from the municipality and from information about costs from the Red Cross respite center. Hereby it can be investigatet if there is any difference in health economic costs between the two groups.
5 secondary outcomes
Health Related Quality of Life (EQ-5D-5L)
Time frame: 3 months
Health economic costs
Time frame: 6 months
Elective health care costs
Time frame: 3 and 6 months
Acute health care costs
Time frame: 3 and 6 months
Social costs
Time frame: 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
- Derived from this study: PubMed 32503545Bring C, Kruse M, Ankarfeldt MZ, Brunes N, Pedersen M, Petersen J, Andersen O. Post-hospital medical respite care for homeless people in Denmark: a randomized controlled trial and cost-utility analysis. BMC Health Serv Res. 2020 Jun 5;20(1):508. doi: 10.1186/s12913-020-05358-4.
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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.
Ove Andersen, PhD, MD principal investigator
Clinical Research Centre, University Hospital of Copenhagen, Hvidovre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red Cross Respite care in people with Homelessness and Respite Care, run by Hvidovre University Hospital 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 30 May 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health economic costs (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02649595, which also lists 1 linked publication.
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 30 May 2018.