A Personalised Approach Utilising the Frailty Index to Empower Consumers

NCT ID: NCT05292989

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-14
• Study Completion Date: 2026-02-01

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.

Detailed Description

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. It is expected that engagement with patients and clinicians in regards to frailty will address expectations and subsequently support the ability of patients/consumers and clinicians to make informed decisions that minimise risks and maximise benefits in regards to surveillance colonoscopies.

Conditions

Gastrointestinal Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Frailty Assessment

Intervention Type: OTHER

Personalised (tailored) approach that includes assessment of frailty and structured information provided to the consumer

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.

Group Type: PLACEBO_COMPARATOR

Standard Care

Intervention Type: OTHER

Standard care practice

Interventions

Frailty Assessment

Personalised (tailored) approach that includes assessment of frailty and structured information provided to the consumer

Intervention Type: OTHER

Standard Care

Standard care practice

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Princess Alexandra Hospital, Brisbane, Australia

OTHER

Sponsor Role: lead

Responsible Party

Gerald Holtmann

Director of Gastroenterology & Hepatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Site Status: RECRUITING

Countries

Australia

Facility Contacts

Natasha Koloski, PhD

Role: primary

Natasha.Koloski@newcastle.edu.au

0407126897

Gerald Holtmann, MD

Role: backup

Gerald.Holtmann@health.qld.gov.au

61 7 3176 2613

Other Identifiers

Frailty Study

Identifier Type: -

Identifier Source: org_study_id