Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000177459
Ethics application status
Approved
Date submitted
5/03/2007
Date registered
21/03/2007
Date last updated
11/12/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Educating carers of patients with advanced pulmonary disease
Scientific title
Health, economic, psychological and social impact of educating carers of patients with advanced pulmonary disease (APD).
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Health, economic, psychological and social costs associated with caring for patients with APD 1695 0
Condition category
Condition code
Respiratory 1787 1787 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The second home visit will occur 6 - 8 weeks after the first home visit.
Intervention code [1] 1618 0
Other interventions
Comparator / control treatment
Control intervention
The control group will receive usual care which includes a face-to-face education session conducted by the CRN with the patient (and carer if present) in hospital (lasting 30-60 minutes). They willl be given a detailed brochure on HOT at that time. Patients will receive a home visit (up to one hour in duration) within 24-48 hours of commencing HOT. 3 monthly telephone calls are made by the CRN to ask if they would like another home visit (lasting up to one hour). These 3 monthly telephone calls (and follow-up home visits if requested) continue while the patient is receiving HOT.
Control group
Active

Outcomes
Primary outcome [1] 2499 0
All cause mortality
Timepoint [1] 2499 0
At 12 months after randomisation
Primary outcome [2] 2500 0
Hospital readmission
Timepoint [2] 2500 0
At 12 months after randomisation
Primary outcome [3] 2501 0
Admission to residential care
Timepoint [3] 2501 0
At 12 months after randomisation
Secondary outcome [1] 4310 0
Health care resource use associated with carer education, oxygen therapy costs, hospital re-admission, General Practitioner (GP) and specialist Medicare Benefits Scheme (MBS) costs, Pharmaceutical Benefits Scheme (PBS) drug use, and carer time.
Timepoint [1] 4310 0
Prospectively collected at a patient level in each trial arm over the 12 month follow up period.
Secondary outcome [2] 4311 0
Patient with APD: health related quality of life and disability using SF-36.
Timepoint [2] 4311 0
At baseline and at 3, 6 and 12, months after intervention commencement.
Secondary outcome [3] 4312 0
Carers of patients with APD: perceived carer burden
Timepoint [3] 4312 0
At baseline and at 3, 6 and 12, months after intervention commencement
Secondary outcome [4] 4313 0
Carers of patients with APD: social support using the Anticipated and Received Social Support Scale
Timepoint [4] 4313 0
At baseline and at 3, 6 and 12, months after intervention commencement
Secondary outcome [5] 4314 0
Carers of patients with APD: degree of mastery or personal control using the Mastery Scale
Timepoint [5] 4314 0
At baseline and at 3, 6 and 12, months after intervention commencement
Secondary outcome [6] 4315 0
Carers of patients with APD: self-esteem using the Self-Esteem Scale
Timepoint [6] 4315 0
At baseline and at 3, 6 and 12, months after intervention commencement
Secondary outcome [7] 4316 0
Carers of patients with APD: ability to conduct lifestyle activties such as domestic chores, household maintenance, service to others and social activities using the Adelaide Activties Profile scale.
Timepoint [7] 4316 0
At baseline and at 3, 6 and 12, months after intervention commencement
Secondary outcome [8] 5606 0
Patients with APD: level of dyspnoea, fatigue, mood and energy using the self-administered Chronic Respiratory Questionnaire
Timepoint [8] 5606 0
At baseline and at 3, 6 and 12 months after intervention commenced
Secondary outcome [9] 5607 0
Carers of patients with APD: level of fatigue using the Identity Consequence Fatigue Scale
Timepoint [9] 5607 0
At baseline and at 3, 6 and 12 months after intervention commenced

Eligibility
Key inclusion criteria
Patient inclusion criteria: patients who are receiving HOT (this includes those already on HOT and any new patients to commence HOT during the study period) and who live in independent accommodation; have at least one carer and receive informal care; are in a stable phase of pulmonary disease with no other life limiting illness.
Carer inclusion criteria: primary care giver of the patient; able to complete written assessments.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient exclusion criteria: are patients receiving palliative oxygen for severe heart disease or for terminal cancer; and those patients who use oxygen for emergency use in life-threatening asthma. There will be no exclusion criteria for carers.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes. Clinical trial staff within the Pharmacy Department at FMC will hold the envelopes. Allocation will involve the Clinical Research Nurses contacting Pharmacy staff to open the sealed envelope and reveal the allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The Clinical Respiratory Nurses who will continue to deliver the usual care to all patients throughout the duration of the study will be blinded to allocation. The assessor conducting the assessment measurements at entry to the study, and at 3, 6 and 12 months following randomisation will be blinded to allocation.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 205 0
5042

Funding & Sponsors
Funding source category [1] 1938 0
Government body
Name [1] 1938 0
National Health and Medical Research Council (NH&MRC) Project grant
Country [1] 1938 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
GPO Box 2100, Adelaide, South Australia 5001
Country
Australia
Secondary sponsor category [1] 1749 0
None
Name [1] 1749 0
Nil
Address [1] 1749 0
Country [1] 1749 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3615 0
Flinders Medical Centre Ethics Committee
Ethics committee address [1] 3615 0
Ethics committee country [1] 3615 0
Australia
Date submitted for ethics approval [1] 3615 0
Approval date [1] 3615 0
01/09/2007
Ethics approval number [1] 3615 0
125/067
Ethics committee name [2] 3616 0
Repatriation General Hospital Ethics Committee
Ethics committee address [2] 3616 0
Ethics committee country [2] 3616 0
Australia
Date submitted for ethics approval [2] 3616 0
Approval date [2] 3616 0
15/09/2007
Ethics approval number [2] 3616 0
RGH 09/07
Ethics committee name [3] 258272 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [3] 258272 0
Ethics committee country [3] 258272 0
Australia
Date submitted for ethics approval [3] 258272 0
21/05/2008
Approval date [3] 258272 0
17/06/2008
Ethics approval number [3] 258272 0
080606
Ethics committee name [4] 258273 0
Australian Government Department of Veterans' Affairs
Ethics committee address [4] 258273 0
Ethics committee country [4] 258273 0
Australia
Date submitted for ethics approval [4] 258273 0
17/12/2007
Approval date [4] 258273 0
04/04/2008
Ethics approval number [4] 258273 0
125/067

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27552 0
Address 27552 0
Country 27552 0
Phone 27552 0
Fax 27552 0
Email 27552 0
Contact person for public queries
Name 10807 0
Dr Ruth Sladek
Address 10807 0
Department of Medicine, Level 6
Flinders Medical Centre
Flinders Drive
Bedford Park, SA 5042
Country 10807 0
Australia
Phone 10807 0
+61 8 82045329
Fax 10807 0
+61 8 82046383
Email 10807 0
Ruth.Sladek@health.sa.gov.au
Contact person for scientific queries
Name 1735 0
Professor Peter Frith
Address 1735 0
Southern Respiratory Services Repatriation General Hospital Daws Road Daw Park SA 5041
Country 1735 0
Australia
Phone 1735 0
+61 8 82751671
Fax 1735 0
Email 1735 0
peter.frith@health.sa.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePragmatic randomised controlled trial of a personalised intervention for carers of people requiring home oxygen therapy.2020https://dx.doi.org/10.1177/1479973119897277
N.B. These documents automatically identified may not have been verified by the study sponsor.