Actively Recruiting

Phase Not Applicable
Age: 65Years - 100Years
All Genders
ID05292989

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.

Led by Princess Alexandra Hospital, Brisbane, Australia · Updated on 2025-08-01

200

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Frailty is a common condition in older adults that can increase the risk of poor health outcomes such as falls, hospital stays, and death. This research aims to study how assessing frailty before a colonoscopy might affect patient satisfaction and the number of colonoscopies avoided. The study is a prospective randomized controlled trial involving patients over 65 years old at Princess Alexandra Hospital, comparing a personalized approach using a frailty assessment to standard care. Participants will be randomly assigned to one of two groups. One group will receive a personalized approach that includes a frailty assessment using tests like grip strength, sit-to-stand timing, balance, and gait speed, along with questionnaires about medical conditions. The gastroenterologist will discuss the results and risks with the patient to help decide about having a surveillance colonoscopy. The other group will receive standard care, which involves discussing the benefits and risks of colonoscopy without the frailty assessment. During the study, participants will complete satisfaction questionnaires at the time of consultation and within weeks after any colonoscopy procedure. Researchers will track how many patients choose to avoid colonoscopy after receiving information and will monitor colorectal cancer-related complications and other causes of death within five years. The study will assess how the personalized approach may impact decision-making and patient satisfaction with outpatient services related to colonoscopy care.

CONDITIONS

Brief Title

A Personalised Approach Utilising the Frailty Index to Empower Consumers

Who Can Participate

Age: 65Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged over 65 years of age
  • Ability to understand the study instructions and answering questionnaires
Not Eligible

You will not qualify if you...

  • Inability to consent or participate in the assessments (e.g. frailty assessment) that are required as part of this project.
  • Lack of informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person or telehealth)

Surveillance

Duration - Up to 2 weeks after consultation

Participants receive either a personalised frailty assessment with structured information to support decision-making about surveillance colonoscopy, or standard care discussions about colonoscopy benefits and risks.

1 consultation visit with the treating Gastroenterologist

Long-term Monitoring

Duration - Up to 5 years

Participants are monitored for colorectal cancer related morbidity and non-colorectal cancer related mortality for up to 5 years after referral.

Follow-up assessments as per routine care

Trial Site Locations

Total: 1 location

1

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia, 4212

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SCREENING

Number of Arms

2

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