RecruitingNot Applicable

A Personalised Approach Utilising the Frailty Index to Empower Consumers

Australia200 participantsStarted 2023-08-14

Plain-language 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.

Who can participate

Age range

65 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients aged over 65 years of age * Ability to understand the study instructions and answering questionnaires 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Satisfaction with the respective outpatient service.

Timeframe: Week 0

Patient satisfaction questions

Timeframe: Week 0

Comprehensive Endoscopy Satisfaction Tool

Timeframe: Week 2-4 After colonoscopy procedure

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.

Timeframe: Week 0-2 after consultation with doctor

Trial details

NCT IDNCT05292989

SponsorPrincess Alexandra Hospital, Brisbane, Australia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-01

View on ClinicalTrials.gov More Gastrointestinal Diseases trials

Plain-language summary

Who can participate

Age range

65 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Satisfaction with the respective outpatient service.

Timeframe: Week 0

Patient satisfaction questions

Timeframe: Week 0

Comprehensive Endoscopy Satisfaction Tool

Timeframe: Week 2-4 After colonoscopy procedure

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.

Timeframe: Week 0-2 after consultation with doctor