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A Personalised Approach Utilising the Frailty Index to Empower Consumers

RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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
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    Eligibility

    Age eligible for study : 65 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2023-08-14

    Primary completion: 2024-09-30

    Study completion finish: 2024-10-26

    study type

    Study type

    SCREENING

    phase

    Phase

      NA

    trial

    Trial ID

    NCT05292989

    Intervention or treatment

    OTHER: Frailty Assessment

    OTHER: Standard Care

    Conditions

    • Gastrointestinal Diseases
    Image related to Gastrointestinal Diseases
    • Condition: Gastrointestinal Diseases

    • OTHER: Frailty Assessment and other drugs

    • Woolloongabba, Queensland, Australia

    • Sponsor: Princess Alexandra Hospital, Brisbane, Australia

    Find a site

    Closest Location:

    Princess Alexandra Hospital

    Research sites nearby

    Select from list below to view details:

    • Princess Alexandra Hospital

      Woolloongabba, Queensland, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    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.
    OTHER: Frailty Assessment
    • Personalised (tailored) approach that includes assessment of frailty and structured information provided to the consumer
    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: Standard Care
    • Standard care practice

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    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 questionsPatients 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 enoughWeek 0
    Comprehensive Endoscopy Satisfaction ToolThis captures the overall satisfaction with the service events (endoscopic procedure and relevant components including the pre-procedure assessment). Higher scores greater satisfactionWeek 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 outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Number of participants with colorectal cancer related morbidityThe number of participants with colorectal cancer related morbidity within 5 years of the referral- including number of patients with clinical diagnoses, hospitalizations, emergency presentations, surgeries, medicationsColorectal cancer related morbidity within 5 years of the referral
    Number of participants with non colorectal cancer related mortality information within 5 years of the referralThe number of participants with non colorectal cancer related mortality information within 5 years of the referral - including number of patients with clinical diagnoses, hospitalizations, outpatient visits, emergency presentations, surgeriesNon colorectal cancer related mortality information within 5 years of the referral

    Frequently Asked Questions

    Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

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    References

    Clinical Trials Gov: A Personalised Approach Utilising the Frailty Index to Empower Consumers

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