A Personalised Approach Utilising the Frailty Index to Empower Consumers

NCT05292989 | Recruiting DMC

• 1 other identifier: Frailty Study
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Diseases

Keywords

colonoscopy surveillance

Outcome Measures

Primary Outcomes (4)

• Satisfaction with the respective outpatient service.

  '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.

  Week 0

• Patient satisfaction questions

  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

  Week 0

• Comprehensive Endoscopy Satisfaction Tool

  This captures the overall satisfaction with the service events (endoscopic procedure and relevant components including the pre-procedure assessment). Higher scores greater satisfaction

  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.

  • 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.

  Week 0-2 after consultation with doctor

Secondary Outcomes (2)

• Number of participants with colorectal cancer related morbidity

  Colorectal cancer related morbidity within 5 years of the referral

• Number of participants with non colorectal cancer related mortality information within 5 years of the referral

  Non colorectal cancer related mortality information within 5 years of the referral

Study Arms (2)

Group 1- Personalised tailored approach

EXPERIMENTAL

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.

Other: Frailty Assessment

Group 2- Standard Care

PLACEBO COMPARATOR

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: Standard Care

Interventions

Frailty Assessment OTHER

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

Group 1- Personalised tailored approach

Standard Care OTHER

Standard care practice

Group 2- Standard Care

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients aged over 65 years of age
• Ability to understand the study instructions and answering questionnaires

You may not qualify if:

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

Sponsors & Collaborators

• Princess Alexandra Hospital, Brisbane, Australia: lead

Study Sites (1)

Princess Alexandra Hospital

Woolloongabba, Queensland, 4212, Australia

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Diseases

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Deidentified data
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gastroenterology & Hepatology

Model Details: Prospective randomized controlled trial design

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: March 23, 2022
• Study Start: August 14, 2023
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)