Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000678897
Ethics application status
Approved
Date submitted
21/06/2012
Date registered
25/06/2012
Date last updated
20/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Standardised assessment and management of frailty in elderly respiratory patients
Scientific title
Elderly respiratory patients with chronic obstructive pulmonary disease (COPD) or asthma undergoing standardised assessment and management of frailty with comprehensive geriatric assessment, compared to those with no frailty management in terms of health outcomes at 12 months.
Secondary ID [1] 280695 0
Nil
Universal Trial Number (UTN)
U1111-1131-9186
Trial acronym
SAFER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frailty 286727 0
Chronic obstructive pulmonary disease (COPD) 286728 0
Asthma 286729 0
Condition category
Condition code
Respiratory 287027 287027 0 0
Chronic obstructive pulmonary disease
Respiratory 287028 287028 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Best practice respiratory care as well as standardised assessment for frailty. If found to be pre-frail or frail, refer for comprehensive geriatric assessment.

Best practice respiratory care at the study site involves 6 monthly one-on-one 30-minute consultations with a respiratory consultant. Over the study period, each participant will attend at least two consultations, (more if needed by participant). Spirometry and 6 min walk tests will be performed before each consultation to monitor respiratory function. Consultations will be tailored to the participant's needs and may include assessing new-onset symptoms, optimising medications for symptom management, referral to pulmonary rehabilitation programs or treatment of exacerbations.

Frailty assessment will be performed using two validated screening tools: the Clinical Frailty Scale (Rockwood, 2005) and the Study of Osteoporotic Frailty Scale (Ensrud, 2008). Comprehensive geriatric assessment will include multidimensional assessment of the patient's medical, psychological and social well-being, RUDAS dementia screen, and construction of a management plan.
Intervention code [1] 285107 0
Early detection / Screening
Comparator / control treatment
Best practice respiratory care only.

Best practice respiratory care at the study site involves 6 monthly one-on-one 30-minute consultations with a respiratory consultant.
Control group
Active

Outcomes
Primary outcome [1] 287366 0
Acute health care utilisation, patient-reported in weekly diary card
Timepoint [1] 287366 0
Weekly monitor for 12 months
Primary outcome [2] 287373 0
Frequency of exacerbations
Timepoint [2] 287373 0
Weekly monitor for 12 months using COPD Assessment Test (CAT)
Primary outcome [3] 287374 0
Health-related quality of life
Timepoint [3] 287374 0
baseline, 6 months, 12 months, measured by Assessment of Quality of Life (AQOL), self-administered questionnaire
Secondary outcome [1] 298022 0
Spirometry (FEV1, FEV1/FVC), to assess severity of airway disease
Timepoint [1] 298022 0
baseline, 6 months, 12 months
Secondary outcome [2] 298023 0
6-minute walk test, a standardised respiratory function test assessing functional capacity
Timepoint [2] 298023 0
baseline, 6 months, 12 months
Secondary outcome [3] 298024 0
Grip strength
Timepoint [3] 298024 0
baseline, 6 months, 12 months; measured by hand-held dynamometers. Dominant hand, best of two attempts
Secondary outcome [4] 298025 0
Change in frailty status
Timepoint [4] 298025 0
baseline, 6 months, 12 months; assessment using Clinical Frailty Scale
Secondary outcome [5] 298026 0
Institutionalisation into a facilitated living residence or nursing home.
Timepoint [5] 298026 0
At 12 months, the participant will be asked if they are still living at home, or have moved into a facilitated living residence or nursing home.
Secondary outcome [6] 298078 0
Mortality
Timepoint [6] 298078 0
At 12 months; as registered on the hospital's administrative patient database, or from follow-up when participant fails to attend respiratory outpatient clinic.

Eligibility
Key inclusion criteria
Symptomatic COPD or asthma
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Currently in a residential care facility
Have previously seen a geriatrician in the past 12 months
Presence of other significant respiratory conditions (eg. lung cancer)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment. Randomisation occurs after recruitment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random numbers
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/07/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285470 0
Self funded/Unfunded
Name [1] 285470 0
Country [1] 285470 0
Australia
Primary sponsor type
Individual
Name
Ms Amy Hsiao
Address
The Prince Charles Hospital
Rode Rd, Chermside
Brisbane
QLD 4032
Country
Australia
Secondary sponsor category [1] 284323 0
Individual
Name [1] 284323 0
A/Prof Ian Yang
Address [1] 284323 0
The Prince Charles Hospital
Rode Rd, Chermside
Brisbane
QLD 4032
Country [1] 284323 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287482 0
TPCH Human research Ethics Committee
Ethics committee address [1] 287482 0
Ethics committee country [1] 287482 0
Australia
Date submitted for ethics approval [1] 287482 0
23/04/2012
Approval date [1] 287482 0
14/06/2012
Ethics approval number [1] 287482 0
HREC/12/QPCH/85

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

Contacts
Principal investigator
Name 34331 0
Address 34331 0
Country 34331 0
Phone 34331 0
Fax 34331 0
Email 34331 0
Contact person for public queries
Name 17578 0
Ms Amy Hsiao
Address 17578 0
The Prince Charles Hospital
Rode Rd, Chermside
Brisbane
QLD 4032
Country 17578 0
Australia
Phone 17578 0
+61 4 12391 052
Fax 17578 0
Email 17578 0
[email protected]
Contact person for scientific queries
Name 8506 0
A/Prof Ian Yang
Address 8506 0
The Prince Charles Hospital
Rode Rd, Chermside QLD 4032, Australia
Country 8506 0
Australia
Phone 8506 0
+61 (0)7 3139 4000
Fax 8506 0
Email 8506 0
[email protected]

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
No additional documents have been identified.