ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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

18/12/2024

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]

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)

Long Covid

Condition category

Condition code

Other

Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Infection

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]

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]

Bland altman analysis between FUNCAP27 (functional capacity 27) and VASF (visual analogue scale for fatigue) to determine validity of the FUNCAP - 27

Timepoint [1]

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]

Composite of carer hours and productivity with FUNCAP 27 scores

Timepoint [1]

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?

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

31/12/2024

Actual

Date of last participant enrolment

Anticipated

31/12/2024

Actual

Date of last data collection

Anticipated

31/07/2025

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]

Charities/Societies/Foundations

Name [1]

Open Medicine Foundation

Address [1]

Country [1]

Australia

Funding source category [2]

University

Name [2]

The University of Melbourne

Address [2]

Country [2]

Australia

Funding source category [3]

Government body

Name [3]

Australian Government Research Training Program Scholarship

Address [3]

Country [3]

Australia

Primary sponsor type

University

Name

The University of Melbourne

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Melbourne Central Human Research Ethics Committee

Ethics committee address [1]

https://research.unimelb.edu.au/work-with-us/ethics-and-integrity/our-ethics-committees

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

31/07/2024

Approval date [1]

25/11/2024

Ethics approval number [1]

Summary

Brief summary

This is a study to determine if the FUNCAP 27 can be used as an instantaneous measure of perceived functional capacity in those with ME/CFS and Long Covid when at baseline and in a state of PEM(Post Exertional Malaise). We are doing this to establish a measure that can detect short term fluctuations in health that will be used in later interventional clinical trials. We aim to recruit 1000 participants for 2 questionnaires and 1 enrolment survey taking 6-20 minutes at enrolment (including reading the consent forms), 15-35 minutes when well and 10 -20 minutes in PEM. The questionnaire can be completed with the aid of a carer and paused for completion at a later time.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Chris Armstrong

Address

Level 2, Bio21 Institute, 30 Flemington Road The University of Melbourne, Victoria 3052

Country

Australia

Phone

+61421500027

Fax

christopher.armstrong@unimelb.edu.au

Contact person for public queries

Name

David Fineberg

Address

Level 2, Bio21 Institute, 30 Flemington Road The University of Melbourne, Victoria 3052

Country

Australia

Phone

+61407522094

Fax

dlfineberg@student.unimelb.edu.au

Contact person for scientific queries

Name

David Fineberg

Address

Level 2, Bio21 Institute, 30 Flemington Road The University of Melbourne, Victoria 3052

Country

Australia

Phone

+61407522094

Fax

dlfineberg@student.unimelb.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
24386	Ethical approval					388232-(Uploaded-05-12-2024-21-51-52)-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.

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