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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
Date last updated
3/04/2024

Titles & IDs
Public title
A Personalised Approach Utilising the Frailty Index to Empower Consumers
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.
Secondary ID [1] 0 0
Frailty Study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal Diseases 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Satisfaction with the respective outpatient service.
Timepoint [1] 0 0
Week 0
Primary outcome [2] 0 0
Patient satisfaction questions
Timepoint [2] 0 0
Week 0
Primary outcome [3] 0 0
Comprehensive Endoscopy Satisfaction Tool
Timepoint [3] 0 0
Week 2-4 After colonoscopy procedure
Primary outcome [4] 0 0
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.
Timepoint [4] 0 0
Week 0-2 after consultation with doctor
Secondary outcome [1] 0 0
Number of participants with colorectal cancer related morbidity
Timepoint [1] 0 0
Colorectal cancer related morbidity within 5 years of the referral
Secondary outcome [2] 0 0
Number of participants with non colorectal cancer related mortality information within 5 years of the referral
Timepoint [2] 0 0
Non colorectal cancer related mortality information within 5 years of the referral

Eligibility
Key inclusion criteria
* Patients aged over 65 years of age
* Ability to understand the study instructions and answering questionnaires
Minimum age
65 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
26/10/2024
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
4212 - Woolloongabba

Funding & Sponsors
Primary sponsor type
Other
Name
Princess Alexandra Hospital, Brisbane, Australia
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT05292989
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05292989