NCT02649595

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

May 30, 2018

Status Verified

May 1, 2018

Enrollment Period

2.2 years

First QC Date

January 6, 2016

Last Update Submit

May 28, 2018

Conditions

HomelessnessRespite Care

Keywords

HomelessHomelessnessRespite careEQ-5DQuality of life questionnaireEconomic evaluationCost-utility analysis

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (5)

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

    3 months

  • Health economic costs

    6 months

  • Elective health care costs

    3 and 6 months

  • Acute health care costs

    3 and 6 months

  • Social costs

    3 and 6 months

Study Arms (2)

Red Cross respite care

OTHER

A 2 week free stay at a Red Cross respite center after hospitalization.

Other: Red Cross Respite care

Streets/communal programmes

NO INTERVENTION

Homeless being discharged from hospital to the streets and communal programmes.

Interventions

Red Cross Respite careOTHER

See detailed description.

Also known as: Omsorgscenter Thorsgade
Red Cross respite care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical research Centre, Amager Hvidovre hospital

Hvidovre, 2650, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 32503545DERIVED

Study Officials

  • Ove Andersen, PhD, MD

    Clinical Research Centre, University Hospital of Copenhagen, Hvidovre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Director

Study Record Dates

First Submitted

January 6, 2016

First Posted

January 7, 2016

Study Start

April 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

May 30, 2018

Record last verified: 2018-05

Locations

DK(1)