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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05292989
Registration number
NCT05292989
Ethics application status
Date submitted
1/03/2022
Date registered
23/03/2022
Titles & IDs
Public title
A Personalised Approach Utilising the Frailty Index to Empower Consumers
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Scientific title
A Personalised Approach Utilising the Frailty Index to Empower Consumers to Make Informed Decisions About Having a Colonoscopy to Avoid Low Value Care. A Prospective Randomized Controlled Trial.
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Secondary ID [1]
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Frailty Study
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal Diseases
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Frailty Assessment
Other interventions - Standard Care
Experimental: Group 1- Personalised tailored approach - If patients are assigned to this group they will be asked to complete a frailty assessment which includes the Fraility Index short form, an assessment of grip strength, time to complete 5 sit-to-stands, balance test, and gait speed along with some questionnaires on comorbid medical condition. The treating Gastroenterologist will then go through the results of the frailty assessment with the patient and based on this information will discuss the benefits and risks associated with having a surveillance colonoscopy. The patient will then decide if they would like to go ahead with a surveillance colonoscopy and the treating Gastroenterologist will provide further advice as required. The frailty assessment is intended to be done at the time of the appointment with the specialist. However, operational requirements may dictate that e.g. a telehealth delivered occasion of service is done at a separate date.
Placebo comparator: Group 2- Standard Care - Patients assigned to this group will discuss the benefits and risks associated with having a surveillance colonoscopy with the treating Gastroenterologist and will decide whether to proceed with the colonoscopy.
Other interventions: Frailty Assessment
Personalised (tailored) approach that includes assessment of frailty and structured information provided to the consumer
Other interventions: Standard Care
Standard care practice
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Satisfaction with the respective outpatient service.
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Assessment method [1]
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'Based only upon your recent experience when you received a consultation in relation to a potential future endoscopic test, how likely are you to recommend the respective health care organization (PAH or RWBH) to a friend, family member or colleague?.'
Please rate your experience on a scale of 1 to 10, where 1 is extremely unlikely and 10 extremely likely.
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Timepoint [1]
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Week 0
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Primary outcome [2]
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Patient satisfaction questions
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Assessment method [2]
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Patients will be asked
Overall, how would you rate the care you received? 1. Very good 2. Good 3. Adequate 4. Poor 5. Very poor
Were you involved as much as you wanted to be in decisions about your care and treatment? 1. Yes, definitely 2. Yes, to some extent 3. No, not enough
How much information about your condition or treatment was given to you? 1. The right amount 2. Too much 3. Not enough
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Timepoint [2]
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Week 0
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Primary outcome [3]
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Comprehensive Endoscopy Satisfaction Tool
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Assessment method [3]
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This captures the overall satisfaction with the service events (endoscopic procedure and relevant components including the pre-procedure assessment). Higher scores greater satisfaction
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Timepoint [3]
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Week 2-4 After colonoscopy procedure
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Primary outcome [4]
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Percentage of consumers in the intervention and control group that are referred for a surveillance colonoscopies who decide not have the procedure based upon the information provided.
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Assessment method [4]
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• Percentage of consumers in the intervention and control group that are referred for a surveillance colonoscopies who decide not have the procedure based upon the information provided.
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Timepoint [4]
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Week 0-2 after consultation with doctor
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Secondary outcome [1]
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Number of participants with colorectal cancer related morbidity
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Assessment method [1]
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The number of participants with colorectal cancer related morbidity within 5 years of the referral- including number of patients with clinical diagnoses, hospitalizations, emergency presentations, surgeries, medications
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Timepoint [1]
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Colorectal cancer related morbidity within 5 years of the referral
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Secondary outcome [2]
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Number of participants with non colorectal cancer related mortality information within 5 years of the referral
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Assessment method [2]
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The number of participants with non colorectal cancer related mortality information within 5 years of the referral - including number of patients with clinical diagnoses, hospitalizations, outpatient visits, emergency presentations, surgeries
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Timepoint [2]
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Non colorectal cancer related mortality information within 5 years of the referral
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Eligibility
Key inclusion criteria
* Patients aged over 65 years of age
* Ability to understand the study instructions and answering questionnaires
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Minimum age
65
Years
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Maximum age
100
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Inability to consent or participate in the assessments (e.g. frailty assessment) that are required as part of this project.
* Lack of informed consent
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/08/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
26/10/2024
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment postcode(s) [1]
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4212 - Woolloongabba
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Funding & Sponsors
Primary sponsor type
Other
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Name
Princess Alexandra Hospital, Brisbane, Australia
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Frailty is a common clinical syndrome in older adults that may carry an increased risk for poor health outcomes including falls, hospitalisation, and mortality. Having a colonoscopy can be associated with potential adverse outcomes in frail patients. At present, however, frailty is not routinely assessed in gastroenterological clinical practice. In a prospective randomised controlled study consenting patients over 65 years at the Princess Alexandra Hospital will receive either a) personalised (tailored) approach that includes assessment of frailty and structured information provided to the consumer or b) current standard practice in regards to having a surveillance colonoscopy to determine the effects on patient satisfaction and percentage of colonoscopies avoided.
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Trial website
https://clinicaltrials.gov/study/NCT05292989
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05292989