Skip to main content
OpenTrials
Completed

NCT Number: NCT02649595

Bridge Copenhagen - Respite Care for Homeless People

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical research Centre, Amager Hvidovre hospital

Hvidovre, 2650, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Red Cross Respite care

Other

See detailed description.

Other names: Omsorgscenter Thorsgade

Primary outcomes

  1. 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.

Secondary outcomes

  1. Health Related Quality of Life (EQ-5D-5L)

    Time frame: 3 months

    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.

  2. Health economic costs

    Time frame: 6 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 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.

  3. Elective health care costs

    Time frame: 3 and 6 months

    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

  4. Acute health care costs

    Time frame: 3 and 6 months

    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

  5. Social costs

    Time frame: 3 and 6 months

    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

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Collaborators

  • Copenhagen Municipality, Denmark
  • Red Cross Copenhagen
  • Region Capital Denmark

Registry information

Acronym: BC

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 7, 2016
Registry last updated
May 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.