Individualised patient education as supportive lung infection protective technique among patients with acute leukaemia

ISRCTN	ISRCTN36674014
DOI	https://doi.org/10.1186/ISRCTN36674014
Secondary identifying numbers	N/A

Submission date: 09/12/2009
Registration date: 18/05/2010
Last edited: 16/12/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Tom Møller (Moeller)
Scientific

The University Hospitals Centre for Nursing and Care Research UCSF
Rigshospitalet afsnit 7331
Blegdamsvej 9
Copenhagen
2100
Denmark

Phone	+45 (0)3545 7336
Email	ucsf@ucsf.dk

Study information

Study design	Randomised controlled clinical intervention study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/10/2008
Completion date	01/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	100
Key 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.
Key exclusion criteria	1. non-Danish speaking 2. Psychotic patients 3. Patients requiring care in Intensive Care Units (ICUs)
Date of first enrolment	01/10/2008
Date of final enrolment	01/12/2010

Locations

Countries of recruitment

Denmark

Study participating centre

The University Hospitals Centre for Nursing and Care Research UCSF

Copenhagen
2100
Denmark

Sponsor information

Lundbeck Foundation (Denmark)
Charity

Universitetshospitalernes Center for Sygepleje- og Omsorgsforskning
Rigshospitalet afsnit 7331
Blegdamsvej 9
2100 København Ø
Copenhagen
2100
Denmark

Phone	+45 (0)35457336
Email	bente@ucsf.dk
Website	http://www.ucsf.dk/
"ROR"	https://ror.org/03hz8wd80

Funders

Funder type

Charity

Lundbeck Foundation (Denmark) (ref: FP 28/2007)
Private sector organisation / Other non-profit organizations

Alternative name(s): Lundbeckfonden
Location: Denmark

Copenhagen University Hospital Rigshospitalet (Denmark)

No information available

Wedell-Wedellsborg Foundation (Denmark) (ref: 381668/933)

No information available

ANCOTRANS (Denmark) - Donation

No information available

Familien Hede Nielsens Foundation (Denmark)

No information available

Ole Wissing's Foundation for Research in Leukaemia (Denmark)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2016		Yes	No