Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001479594
Ethics application status
Approved
Date submitted
31/07/2024
Date registered
18/12/2024
Date last updated
29/06/2025
Date data sharing statement initially provided
18/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
FUNCAP-27 (Functional Capacity), A Repeat Measure Study (FARMS), A survey to establish the utility of the FUNCAP-27 for serial measurements in Myalgic Encephalomyelitis, Chronic Fatigue Syndrome (ME/CFS) and Long Covid
Scientific title
FUNCAP-27 (Functional Capacity), A Repeat Measure Study (FARMS), A validation study utilising a modified FUNCAP 27 for instantaneous serial measurements in the assessment of Myalgic Encephalomyelitis, Chronic Fatigue Syndrome (ME/CFS) and Long Covid
Secondary ID [1] 312664 0
nil
Universal Trial Number (UTN)
U1111-1311-3978
Trial acronym
FARMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ME/CFS (Myalgic Encephalomyelitis / Chronic Fatigue Syndrome) 334637 0
Long Covid 334638 0
Condition category
Condition code
Other 331220 331220 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
Infection 331280 331280 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The current FUNCAP 27 has established validation at 4 week intervals. We wish to determine if this questionnaire is useful as a reliable, instantaneous and repeatable measure of perceived functional energy utilisation and consequence capacity.

Assessment will take place over 2 situations. The first questionnaire will be completed when experiencing PEM (post exertional malaise) while the second will be completed once returned to baseline level of health and function.

This project should take between 30 minutes and 1 hour 20 minutes in total and is comprised of 16 questions at enrolment, 48 questions when in crash or PEM (post exertional malaise) state and 71 questions on the follow up recovered (when well) questionnaire.
Participation in this project involves completing an enrolment questionnaire followed by a modified version of the FUNCAP 27 to reflect the measurement of perceived functional capacity, questions about your social and medical circumstances.

Questionnaires will be delivered electronically via REDCap software and can be completed by smart phone, tablet or computer. We aim to recruit 1000 participants for this study and encourage the use of carers to assist in completion of the questionnaire. We are hoping to collect answers from all participants over 6 months
Intervention code [1] 329184 0
Not applicable
Comparator / control treatment
This observational trial will compare the FUNCAP 27 (FUNctional CAPacity) to the VASF (Visual analog scale for fatigue) which will be complete in tandem at both crash and well states.
Control group
Active

Outcomes
Primary outcome [1] 338994 0
Bland altman analysis between FUNCAP27 (functional capacity 27) and VASF (visual analogue scale for fatigue) to determine validity of the FUNCAP - 27
Timepoint [1] 338994 0
A maximum of 6 weeks following the initial completion of the crashed (PEM) questionnaire with which to complete the recovered (when well) questionnaire. Participants will have 6 months to complete their first PEM questionnaire
Secondary outcome [1] 438201 0
Composite of carer hours and productivity with FUNCAP 27 scores
Timepoint [1] 438201 0
hour logs and production over the preceding 24 hours from questionnaire completion

Eligibility
Key inclusion criteria
An existing diagnosis of ME/CFS and/or Long Covid
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. English language not considered to be at a proficient level
2. Not meeting all aspects of the NICE guidelines as below:
a. Debilitating fatigue that is worsened by activity, is not caused by excessive cognitive, physical, emotional or social exertion, and is not significantly relieved by rest.
b. Post-exertional malaise after activity in which the worsening of symptoms: is often delayed in onset by hours or days, is disproportionate to the activity, and has a prolonged recovery time that may last hours, day or weeks.
c. Unrefreshing sleep and sleep disturbance (or both), which may include: feeling exhausted, feeling flu-like and stiff on waking, broken or shallow sleep, altered sleep pattern or hypersomnia (increased sleepiness affecting performance and function)
d. Cognitive difficulties (sometimes described as 'brain fog'), which may include: problems finding words or numbers, difficulty in speaking, slowed responsiveness, short-term memory problems, and difficulty concentrating or multitasking.

Study design
Purpose
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Results will be analysed by examining the bland altman correlation to assess to concordance between the changes in disease states and their correlation of FUNCAP 27 scores to VASF scores

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/06/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
28/02/2026
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 317101 0
Government body
Name [1] 317101 0
Australian Government Research Training Program Scholarship
Country [1] 317101 0
Australia
Funding source category [2] 317100 0
University
Name [2] 317100 0
The University of Melbourne
Country [2] 317100 0
Australia
Funding source category [3] 317099 0
Charities/Societies/Foundations
Name [3] 317099 0
Open Medicine Foundation
Country [3] 317099 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 319356 0
None
Name [1] 319356 0
Address [1] 319356 0
Country [1] 319356 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315848 0
University of Melbourne Central Human Research Ethics Committee
Ethics committee address [1] 315848 0
Ethics committee country [1] 315848 0
Australia
Date submitted for ethics approval [1] 315848 0
31/07/2024
Approval date [1] 315848 0
25/11/2024
Ethics approval number [1] 315848 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135986 0
Dr Chris Armstrong
Address 135986 0
Level 2, Bio21 Institute, 30 Flemington Road The University of Melbourne, Victoria 3052
Country 135986 0
Australia
Phone 135986 0
+61421500027
Fax 135986 0
Email 135986 0
[email protected]
Contact person for public queries
Name 135987 0
David Fineberg
Address 135987 0
Level 2, Bio21 Institute, 30 Flemington Road The University of Melbourne, Victoria 3052
Country 135987 0
Australia
Phone 135987 0
+61 395271216
Fax 135987 0
Email 135987 0
[email protected]
Contact person for scientific queries
Name 135988 0
David Fineberg
Address 135988 0
Level 2, Bio21 Institute, 30 Flemington Road The University of Melbourne, Victoria 3052
Country 135988 0
Australia
Phone 135988 0
+61 395271216
Fax 135988 0
Email 135988 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    farms approval hrec.pdf


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.