Condition category
Respiratory
Date applied
17/01/2008
Date assigned
20/03/2008
Last edited
20/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Torbjørn Haugen

ORCID ID

Contact details

HØKH
Akershus Unversitetssykehus HF
Sykehusveien 27
Lørenskog
1478
Norway

Additional identifiers

EudraCT 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

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

Trial setting

Hospitals

Trial 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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/03/2008

Overall trial end date

01/03/2010

Reason abandoned

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

Patient

Age group

Senior

Gender

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

Trial 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

http://www.helse-ost.no

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes