Contact information
Type
Scientific
Primary contact
Mr Tom Møller (Moeller)
ORCID ID
Contact details
The University Hospitals Centre for Nursing and Care Research UCSF
Rigshospitalet afsnit 7331
Blegdamsvej 9
Copenhagen
2100
Denmark
+45 (0)3545 7336
ucsf@ucsf.dk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Patient education as a complementary non-pharmacological intervention towards hospital acquired lung infection among patients with acute myeloid leukaemia and chemotherapy induced neutropenia
Acronym
Study hypothesis
Individualised structured patient education including clinical procedures for self-measurement of Lung Capacity / Spirometry in combination with Positive Expiratory pressure (PEP) can reduce hospital acquired pneumonia.
Ethics approval
1. The Ethical Scientific Committee of Copenhagen Region, 19/06/2008, ref: H-D-2008-025
2. The Danish Data Protection Agency, 22/01/2008, ref: 2008-41-1728
Study design
Randomised controlled clinical intervention study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Acute Myeloid Leukaemia (AML); lung infection prevention
Intervention
Patient education and training to perform self-measurement of lung capacity and mechanical lung traning with Positive Expiratory Pressure (PEP).
Patients are included when diagnosed with AML and chemotherapy has commenced. Follow-up period is planned to 3 months after inclusion.
The intervention is nurse-led and consists of a structured three level based patient education program given individually to each patient. One program given to both control and intervention group is used for patients training in self-measurement of lung capacity / spirometry twice a day with an electronic pocket monitor, 'PiKo-6'. The time spent by the clinical nurse specialist for initial instruction and education in spirometry varies within 1.5 - 2.5 hours per patient.
The second program is provided only to the intervention group and deals with lung training consisting Positive Expiratory Pressure (PEP) using a PEP-flute twice to four times daily depending on values from lung capacity measurement. Time used for initial instruction varies from 30 mins to 1 hour per patient.
Both programs describe focus, actions and aims on each of the three levels in the forms. Patients are left in charge when completing the 3 levels based on appraisal from the clinical nurse specialist. Patients are seen as inpatients or outpatients every 7 - 14 days to discuss patients assessments and visualize their lung capacity on an EDB-based monitor.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Incidence of X-ray verified lung infiltrates during the 3 month follow up period
2. Forced Expiratory Volume in 1 second (FEV1) as predictive diagnostic tool for pneumonia
Secondary outcome measures
1. Quality of Life (QOL) - EORTC-QLQ-C30
2. SF36 short form
3. Hospital Anxiety Depression (HAD)
4. Self-efficacy
5. Coping - Mini Mental Adjustment to Cancer (Mini-MAC)
Above outcomes measured at baseline and at 3 month follow up
6. Qualitative findings derived from semi-structured interviews conducted at the end of 3 month follow up.
Overall trial start date
01/10/2008
Overall trial end date
01/12/2010
Reason abandoned
Eligibility
Participant inclusion criteria
Patients (>18 years) with Acute Myeloid Leukaemia (AML) and Myelodysplatic Syndrome demanding intensive intravenous chemotherapy and diagnosed at the Copenhagen University Hospitales Rigshospitalet and Herlev Hospital.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. non-Danish speaking
2. Psychotic patients
3. Patients requiring care in Intensive Care Units (ICUs)
Recruitment start date
01/10/2008
Recruitment end date
01/12/2010
Locations
Countries of recruitment
Denmark
Trial participating centre
The University Hospitals Centre for Nursing and Care Research UCSF
Copenhagen
2100
Denmark
Sponsor information
Organisation
Lundbeck Foundation (Denmark)
Sponsor details
Universitetshospitalernes Center for Sygepleje- og Omsorgsforskning
Rigshospitalet afsnit 7331
Blegdamsvej 9
2100 København Ø
Copenhagen
2100
Denmark
+45 (0)35457336
bente@ucsf.dk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Lundbeck Foundation (Denmark) (ref: FP 28/2007)
Alternative name(s)
Lundbeck Foundation
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
Denmark
Funder name
Copenhagen University Hospital Rigshospitalet (Denmark)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Wedell-Wedellsborg Foundation (Denmark) (ref: 381668/933)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
ANCOTRANS (Denmark) - Donation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Familien Hede Nielsens Foundation (Denmark)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Ole Wissing's Foundation for Research in Leukaemia (Denmark)
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
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26661344