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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07175961
Registration number
NCT07175961
Ethics application status
Date submitted
29/08/2025
Date registered
16/09/2025
Date last updated
16/09/2025
Titles & IDs
Public title
Improving Survivorship for Critically Ill Patients Aged 65 and Over
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Scientific title
Improving Survivorship for Critically Ill Patients Aged 65 and Over
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Secondary ID [1]
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ANZIC-RC/CH007
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Universal Trial Number (UTN)
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Trial acronym
IMPROVE-65
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Critical Illness
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Recovery Outcomes
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Care Coordination
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Multicomponent telehealth care coordination
No intervention: Control: Standard care - Paticipants randomised to the control group will not receive the intervention. They will be contacted by the study team to collect data on access to primary health care services post hospital discharge and will be contacted at D90 and D180 by outcome assessors to collected patient reported outcomes.
Experimental: Intervention - Participants randomised into this group will receive tailored care coordination and support to develop recovery goals post hospital discharge.
Other interventions: Multicomponent telehealth care coordination
Participants randomised into the intervention group will be assigned a recovery navigator prior to discharge from hospital. The recovery navigator will provide the participant with a study tailored discharge summary, arrange the patients first appointment with their general practitioner and will ensure medications are reconciled prior to hospital discharge. The recovery coordinator will arrange weekly calls with the participant for the first 4 weeks and then fortnightly until week 12 to set recovery goals and assess recovery goals and navigator further primary care support if required. Participants will also be called at Day 90 and 180 by outcome assessors to collected patient reported outcomes.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Hierarchical composite endpoint of death, avoidable hospital readmission and new global disability measured using the World Health Organisation Disability Schedule (WHODAS) 2.0 12L at 90 days after randomisation.
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Assessment method [1]
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The hierarchical outcome of interest is a combination of out-of-hospital mortality, need for hospital readmission and WHODAS 2.0 score. The primary composite endpoint will be analysed using the win odds to account for ties.
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Timepoint [1]
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From randomisation until 90 days post randomisation.
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Secondary outcome [1]
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All-cause mortality to day 180
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Assessment method [1]
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Timepoint [1]
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From randomisation until Day 180 outcome assessment is completed.
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Secondary outcome [2]
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Avoidable acute hospital readmissions to day 90
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Assessment method [2]
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Measured by reviewing the number of emergency admissions to hospital participants had between randomisation and day 90.
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Timepoint [2]
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From randomisation until day 90 post randomisation
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Secondary outcome [3]
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Patient Activation Measure (PAM) at day 90
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Assessment method [3]
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Timepoint [3]
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From randomisation until Day 90 post randomisation.
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Secondary outcome [4]
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Activities of Daily Living at Day 90
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Assessment method [4]
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Measured with the EuroQoL 5-Dimension, 5-Level (EQ-5D-5L). Five questions are asked relating to mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each question has five response options from 1 (no problems) to 5 (extreme problems).
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Timepoint [4]
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From randomisation until Day 90 outcome assessment is completed.
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Secondary outcome [5]
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Self-rated health at Day 90
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Assessment method [5]
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Measured using the EQ-Visual Analogue Scale (EQ-VAS) at Day 180. Measured on a scale of 0 to 100. The participant is asked to rate their health on the day of the assessment with 0 being the worst health and 100 being the best.
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Timepoint [5]
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From randomisation until Day 90
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Secondary outcome [6]
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Activities of Daily Living at Day 180
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Assessment method [6]
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Measured with the EuroQoL 5-Dimension, 5-Level (EQ-5D-5L). Five questions are asked relating to mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each question has five response options from 1 (no problems) to 5 (extreme problems).
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Timepoint [6]
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From randomisation until Day 180
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Secondary outcome [7]
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Self-rated health at Day 180
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Assessment method [7]
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Measured using the EQ-Visual Analogue Scale (EQ-VAS) at Day 180. Measured on a scale of 0 to 100. The participant is asked to rate their health on the day of the assessment with 0 being the worst health and 100 being the best.
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Timepoint [7]
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From randomisation to Day 180
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Secondary outcome [8]
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New disability at Day 90
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Assessment method [8]
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Measured with the World Health Organization Disability Assessment Schedule 2.0 Proxy Administered. (WHODAS 2.0 12L). New disability is considered a change in WHODAS \>10% from baseline). The participant is asked 12 questions relating to cognition, mobility, self-care, interacting with people, life activities and participation. Each question is ranked on a 5-point Likert scale from 0 (None) to 4 (Extreme or cannot do). The total score is the sum of all 12 question and can range from 0 to 48 with a higher score indicating a greater degree of disability or function.
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Timepoint [8]
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From randomisation to D90 outcome assessment is completed.
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Secondary outcome [9]
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New disability at Day 180
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Assessment method [9]
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Measured with the World Health Organization Disability Assessment Schedule 2.0 Proxy Administered. (WHODAS 2.0 12L). New disability is considered a change in WHODAS \>10% from baseline). The participant is asked 12 questions relating to cognition, mobility, self-care, interacting with people, life activities and participation. Each question is ranked on a 5-point Likert scale from 0 (None) to 4 (Extreme or cannot do). The total score is the sum of all 12 question and can range from 0 to 48 with a higher score indicating a greater degree of disability or function.
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Timepoint [9]
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From randomisation until Day 180 assessment is complete
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Secondary outcome [10]
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Activities of daily living at day 90
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Assessment method [10]
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Measured using the Katz Index of Independence in Activities of Daily Living (ADL) which assesses basic activities of daily living. The participant is asked about 6 categories of daily living and given a score of 0 or 1 based on their ability to complete the task either independently or with support. A final score between 0 and 6 is calculated, with the higher score indicating greater independence.
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Timepoint [10]
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From randomisation until Day 90
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Secondary outcome [11]
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Activities of daily living at day 180
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Assessment method [11]
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Measured using the Katz Index of Independence in Activities of Daily Living (ADL) which assesses basic activities of daily living. The participant is asked about 6 categories of daily living and given a score of 0 or 1 based on their ability to complete the task either independently or with support. A final score between 0 and 6 is calculated, with the higher score indicating greater independence.
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Timepoint [11]
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From randomisation until day 180
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Secondary outcome [12]
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Instrumental activities of daily living at day 90
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Assessment method [12]
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Measured using the Lawton Instrumental Activities of Daily Living Scale. Eight categories of daily activities are asked, and the participant is scored for each category with either a 0 or a 1 based on the highest functional level for each activity. The overall score will be between 0 and 8 with higher scores indicating greater functional independence.
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Timepoint [12]
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From randomisation until day 90
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Secondary outcome [13]
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Instrumental activities of daily living at day 180
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Assessment method [13]
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Measured using the Lawton Instrumental Activities of Daily Living Scale. Eight categories of daily activities are asked, and the participant is scored for each category with either a 0 or a 1 based on the highest functional level for each activity. The overall score will be between 0 and 8 with higher scores indicating greater functional independence.
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Timepoint [13]
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From randomisation until day 180
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Secondary outcome [14]
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Anxiety and Depression at day 180
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Assessment method [14]
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Measured using the Hospital Anxiety and Depression scale (HADs) which is a 14 item scale that consists of two seven item sub-scales; seven questions for anxiety and seven questions for depression. The scale is measured with each item measured on a four point Likert scale (0 to 3). The higher the score indicating the greater the severity.
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Timepoint [14]
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From randomisation until D180 outcome assessment is completed.
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Secondary outcome [15]
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Participant cognition at day 180
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Assessment method [15]
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Measured using the Montreal Cognitive Assessment Blind (MOCA-Blind)
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Timepoint [15]
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At day 180 from randomisation
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Secondary outcome [16]
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Post traumatic stress disorder at day 180
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Assessment method [16]
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Measured using the Impact of Events Scale 6 Items that consists of 6 questions all measured on a 5-point Likert scale from 0 to 4 with the higher the score indicating greater severity. 0 - Not at all; 1 - A little bit; 2 - Moderately; 3 - Quite a bit; 4 - Extremely
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Timepoint [16]
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Measured at Day 180 after randomisation
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Secondary outcome [17]
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Cost-effectiveness of the intervention at day 180
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Assessment method [17]
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The primary cost-effectiveness analysis will be conducted from the Australian healthcare payer's perspective using an analytical time horizon of 6-months. Post discharge costs will be determined using patient-level data linkage to determine long-term health care use (including readmission to hospital and emergency department presentation). Quality-adjusted life years (QALYs) will be calculated using information from the Euroqol 5-dimension 5 level (EQ-5D-5L) assessed at day 180 post randomisation, combined with information on vital status. We will calculate incremental cost-effectiveness ratios, including the cost per additional QALY for the intervention versus standard care. To increase the robustness of the sampling, we will use non-parametric bootstrapping with unrestricted random sampling to produce cost and effectiveness replications, and confidence intervals for the cost-effectiveness ratios.
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Timepoint [17]
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From randomisation until D180.
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Eligibility
Key inclusion criteria
* Was admitted to ICU for at least 48 hours
* is aged 65 years or older at the time of hospital admission
* Is alive and ready for hospital discharge
* Is expected to survive for 6 months beyond hospital discharge (e.g. not discharged on palliative care)
* Has new disability at hospital discharge measured using the global disability scale
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Minimum age
65
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Is not expected to reside in Australia for 3 months following randomisation.
* Is not expected to be living at home within 2 weeks of acute hospital discharge (e.g. prolonged inpatient rehabilitation)
* Is unable to identify a GP or GP clinic and/or are unable or unwilling to attend a GP appointment scheduled by the recovery navigator.
* Has an existing recovery or nurse navigator as part of their routine clinical care to assist with planning their care after hospital discharge
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/11/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/02/2028
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Actual
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Sample size
Target
300
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Cabrini Hospital Malvern - Melbourne
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Recruitment hospital [2]
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Monash Health - Melbourne
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Recruitment postcode(s) [1]
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3144 - Melbourne
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Recruitment postcode(s) [2]
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3168 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Australian and New Zealand Intensive Care Research Centre
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
IMPROVE-65 is a randomised control trial designed specifically for people aged over 65 who have survived critical illness. It aims to support patients and general practitioners by providing timely, personalised information to help them work together to make informed goals and decisions about their care after hospital discharge. The aim of the study is to improve recovery and avoid preventable hospital readmissions.
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Trial website
https://clinicaltrials.gov/study/NCT07175961
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Carol Hodgson, Professor
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Address
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Monash University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Anne Mather
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Address
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Country
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Phone
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+61 3 9903 0263
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
At the conclusion of the study, the study management committee will consider requests from researchers who provide a methodologically sound scientific proposal as per the Data Sharing Policy set out in the ANZIC Research Centre Terms of Reference.
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT07175961
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