Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Hospital at home care in exacerbations of chronic obstructive pulmonary disease (COPD)
Acronym
HBKOLS
Study hypothesis
Previous studies in other countries indicate that home treatment with nursing support is suitable in selected patients with exacerbations of chronic obstructive pulmonary disease (COPD), presenting to hospital as an emergency.
Hypothesis:
Three days of hospital at home care in mild to moderate exacerbations of COPD is cost saving in the Norwegian health care system and implies at least the same level of disease-related quality of life as traditional hospital care.
Ethics approval(s)
Ethics approval received from the Regional Ethics Committee for Medical Research of East Norway on the 21st December 2007 (ref: 1.2007.2613).
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Chronic obstructive pulmonary disease (COPD)
Intervention
Hospital-at-home group (experimental arm):
Three days organised by the hospitals with specially trained nurses. In the same period of time the patient can contact the lung department at the hospital by phone for advice. Thereafter, if medical follow up is needed, by the primary care system (primary physician, home nurses).
Hospital group (control arm):
As long as needed in the hospital. Thereafter, if needed, by the primary care personnel as for the other group. In contrast to the other group, the length of the in-hospital treatment is not specified.
Follow up for both groups: After 6 weeks, 6 months and 12 months.
Intervention type
Other
Primary outcome measure
Health economy measures.
Time points: 6 weeks, 6 months and 12 months.
Secondary outcome measures
1. Level of disease-related quality of life, measured with the St. George Respiratory Questionnaire
2. Mental health (level of anxiety and depression), measured with the Hospital Anxiety and Depression Scale
Time points: 6 weeks, 6 months and 12 months.
Overall study start date
01/03/2008
Overall study end date
01/03/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients under 80 years of age, either sex, with exacerbation of COPD
2. Presenting to the hospital as an emergency
Participant type(s)
Patient
Age group
Senior
Sex
Both
Target number of participants
180
Participant exclusion criteria
1. Serious exacerbation including impending or actual respiratory failure
2. Serious comorbidity
Recruitment start date
01/03/2008
Recruitment end date
01/03/2010
Locations
Countries of recruitment
Norway
Study participating centre
HØKH
Lørenskog
1478
Norway
Sponsor information
Organisation
Regional Authorities for Hospital Care, South-East Norway (Helse Sør-Øst Norge RHF) (Norway)
Sponsor details
PO Box 404
Hamar
2301
Norway
+47 625 85 500
postmottak@helse-ost.no
Sponsor type
Government
Website
ROR
Funders
Funder type
Government
Funder name
Regional Authorities for Hospital Care, South-Eastern Norway (Helse Sør-Øst RHF) (Norway)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Norwegian Research Council (Norsk Forskningsråd) (Norway)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|