Registration form

Expression of Interest and Eligibility questionnaire

Thank you for your interest in taking part in the TIPTOE trial. This trial will evaluate the effectiveness of a personalised support package for individuals living with knee and/or hip Osteoarthritis and other long-term conditions, compared to usual care currently available from the NHS.

Please review the Participant Information Sheet for further information about the study if you have any questions or concerns about taking part.

REDCap variable: crf01a_desctext1

Please confirm you have read the participant information sheet

REDCap variable: eoi1pis

*required field

Please take your time to read through the participant information sheet.

REDCap variable: eoi1pis_warn

Branching logic: [eoi1pis] = '2'

Please complete the following questions to confirm whether you are eligible for the TIPTOE trial

Inclusion Criteria

REDCap variable: crf01a_desctext2

1. I am aged 70 years or over.

REDCap variable: eoi2elig1

1. I am aged 65 years or over.

REDCap variable: eoi2elig1_1

*required field

Thank you for your interest in taking part in the TIPTOE trial. Unfortunately you need to be 65 years of age or over to take part in the trial.

REDCap variable: eoi2elig1_warn

Branching logic: [eoi2elig1_1] = '0'

2. I am living in the community independently, or with carer support or in assisted living.

REDCap variable: eoi3elig2

*required field

Thank you for your interest in the TIPTOE trial. Unfortunately you do not meet the criteria to take part in the trial.

REDCap variable: eoi3elig2_warn

Branching logic: [eoi3elig2] = '0'

3. I have knee and/or hip pain in the Osteoarthritis affected joint, which is impacting upon daily living.

REDCap variable: eoi4elig3

*required field

Thank you for your interest in the TIPTOE trial. Unfortunately you do not meet the criteria to take part in the trial.

REDCap variable: eoi4elig3_warn

Branching logic: [eoi4elig3] = '0'

If Yes, please select which joint is affected

REDCap variable: oajoint

Branching logic: [eoi4elig3]=1

*required field

Please proceed to Other Health Conditions

REDCap variable: oajoint_warn1

Branching logic: [eoi2elig1_1]=1 and [eoi3elig2]=1 and [eoi4elig3]=1

Thank you for your interest in the TIPTOE trial. Unfortunately you do not meet the criteria to take part in the trial.

REDCap variable: oajoint_warn2

Branching logic: [eoi2elig1_1]=0 or [eoi3elig2]=0 or [eoi4elig3]=0

Please answer questions about your Other Health Conditions

Self Administered Co-morbidity questionnaire

The following is a list of common problems. Please indicate if you have any co-existing health problems in addition to your knee and/or hip osteoarthritis.

If you have the problem, please indicate if you receive medication or some other type of treatment for it and if the problem limits your activities.

At the end of the form, you can list any other medical conditions that are not listed under "other medical problems"

REDCap variable: scq_desctext1

Do you have heart disease?

REDCap variable: heart

*required field

If Yes (i.e you have heart disease), do you receive treatment for it?

REDCap variable: hrttrx

Branching logic: [heart] = '1'

*required field

If Yes (i.e you have heart disease), does it limit your activities

REDCap variable: htlim

Branching logic: [heart] = '1'

*required field

Do you have high blood pressure?

REDCap variable: bpres

*required field

If Yes (i.e you have high blood pressure), do you receive treatment for it?

REDCap variable: bptrx

Branching logic: [bpres] = '1'

*required field

If Yes (i.e you have high blood pressure), does it limit your activities

REDCap variable: bplim

Branching logic: [bpres] = '1'

*required field

Do you have lung disease?

REDCap variable: lung

*required field

If Yes (i.e you have lung disease), do you receive treatment for it?

REDCap variable: lungtrx

Branching logic: [lung] = '1'

*required field

If Yes (i.e you have lung disease), does it limit your activities

REDCap variable: lunglim

Branching logic: [lung] = '1'

*required field

Do you have diabetes?

REDCap variable: diab

*required field

If Yes (i.e you have diabetes), do you receive treatment for it?

REDCap variable: diabtrx

Branching logic: [diab] = '1'

*required field

If Yes (i.e you have diabetes), does it limit your activities

REDCap variable: diablim

Branching logic: [diab] = '1'

*required field

Do you have an ulcer or stomach disease?

REDCap variable: ulcer

*required field

If Yes (i.e you have an ulcer or stomach disease), do you receive treatment for it?

REDCap variable: ulctrx

Branching logic: [ulcer] = '1'

*required field

If Yes (i.e you have an ulcer or stomach disease), does it limit your activities

REDCap variable: ulclim

Branching logic: [ulcer] = '1'

*required field

Do you have kidney disease?

REDCap variable: kidney

*required field

If Yes (i.e you have kidney disease), do you receive treatment for it?

REDCap variable: kidtrx

Branching logic: [kidney] = '1'

*required field

If Yes (i.e you have kidney disease), does it limit your activities

REDCap variable: kidlim

Branching logic: [kidney] = '1'

*required field

Do you have liver disease?

REDCap variable: liver

*required field

If Yes (i.e you have liver disease), do you receive treatment for it?

REDCap variable: livtrx

Branching logic: [liver] = '1'

*required field

If Yes (i.e you have liver disease), does it limit your activities

REDCap variable: livlim

Branching logic: [liver] = '1'

*required field

Do you have anaemia or other blood disease?

REDCap variable: anblood

*required field

If Yes (i.e you have anaemia or other blood disease), do you receive treatment for it?

REDCap variable: anbloodtrx

Branching logic: [anblood] = '1'

*required field

If Yes (i.e you have anaemia or other blood disease), does it limit your activities

REDCap variable: anbloodlim

Branching logic: [anblood] = '1'

*required field

Do you have cancer?

REDCap variable: cancer

*required field

If Yes (i.e you have cancer), do you receive treatment for it?

REDCap variable: canctrx

Branching logic: [cancer] = '1'

*required field

If Yes (i.e you have cancer), does it limit your activities

REDCap variable: canclim

Branching logic: [cancer] = '1'

*required field

Do you have depression?

REDCap variable: dep

*required field

If Yes (i.e you have depression), do you receive treatment for it?

REDCap variable: deptrx

Branching logic: [dep] = '1'

*required field

If Yes (i.e you have depression), does it limit your activities

REDCap variable: deplim

Branching logic: [dep] = '1'

*required field

Do you have osteoarthritis in any joint other than your knees or hips?

REDCap variable: oa

*required field

If Yes (i.e you have osteoarthritis in any joint other than your knees or hips), do you receive treatment for it?

REDCap variable: oatrx

Branching logic: [oa] = '1'

*required field

If Yes (i.e you have osteoarthritis in any joint other than your knees or hips), does it limit your activities

REDCap variable: oalim

Branching logic: [oa] = '1'

*required field

Do you have back or widespread pain?

REDCap variable: bp

*required field

If Yes (i.e you have back or widespread pain), do you receive treatment for it?

REDCap variable: bpaintrx

Branching logic: [bp] = '1'

*required field

If Yes, (i.e you have back or widespread pain), does it limit your activities?

REDCap variable: bpainlim

Branching logic: [bp] = '1'

*required field

Do you have rheumatoid arthritis?

REDCap variable: ra

*required field

If Yes (i.e you have rheumatoid arthritis), do you receive treatment for it?

REDCap variable: ratrx

Branching logic: [ra] = '1'

*required field

If Yes (i.e you have rheumatoid arthritis), does it limit your activities

REDCap variable: ralim

Branching logic: [ra] = '1'

*required field

Do you have other medical problems?

REDCap variable: othprob

*required field

REDCap variable: otmedn

Branching logic: [othprob] = '1'

*required field

If Yes (i.e you have other medical problems), do you receive treatment for it?

REDCap variable: otmedtrx

Branching logic: [othprob] = '1'

*required field

If Yes (i.e you have other medical problems), does it limit your activities

REDCap variable: otmedlim

Branching logic: [othprob] = '1'

*required field

Do you have other medical problems?

REDCap variable: othprob1

Branching logic: [othprob] = '1'

*required field

REDCap variable: otmedn1

Branching logic: [othprob1] = '1'

*required field

If Yes (i.e you have other medical problems), do you receive treatment for it?

REDCap variable: otmedtrx1

Branching logic: [othprob1] = '1'

*required field

If Yes (i.e you have other medical problems), does it limit your activities

REDCap variable: otmedlim1

Branching logic: [othprob1] = '1'

*required field

Do you have other medical problems?

REDCap variable: othprob2

Branching logic: [othprob1] = '1'

*required field

REDCap variable: otmedn2

Branching logic: [othprob2] = '1'

*required field

If Yes (i.e you have other medical problems), do you receive treatment for it?

REDCap variable: otmedtrx2

Branching logic: [othprob2] = '1'

*required field

If Yes (i.e you have other medical problems), does it limit your activities

REDCap variable: otmedlim2

Branching logic: [othprob2] = '1'

*required field

Do you have other medical problems?

REDCap variable: othprob3

Branching logic: [othprob2] = '1'

*required field

REDCap variable: otmedn3

Branching logic: [othprob3] = '1'

*required field

If Yes (i.e you have other medical problems), do you receive treatment for it?

REDCap variable: otmedtrx3

Branching logic: [othprob3] = '1'

*required field

If Yes (i.e you have other medical problems), does it limit your activities

REDCap variable: otmedlim3

Branching logic: [othprob3] = '1'

*required field

Do you have other medical problems?

REDCap variable: othprob4

Branching logic: [othprob3] = '1'

*required field

REDCap variable: otmedn4

Branching logic: [othprob4] = '1'

*required field

If Yes (i.e you have other medical problems), do you receive treatment for it?

REDCap variable: otmedtrx4

Branching logic: [othprob4] = '1'

*required field

If Yes (i.e you have other medical problems), does it limit your activities

REDCap variable: otmedlim4

Branching logic: [othprob4] = '1'

*required field

Please proceed to the Exclusion criteria

REDCap variable: scq_warn1

Branching logic: sum([heart],[bpres],[lung],[diab],[ulcer],[kidney],[liver],[anblood],[cancer],[dep],[bp],[ra],[othprob],[othprob1],[othprob2],[othprob3],[othprob4])>=1

Thank you for your interest in the TIPTOE trial. Unfortunately you do not meet the criteria to take part in the trial.

REDCap variable: scq_warn2

Branching logic: sum([heart],[bpres],[lung],[diab],[ulcer],[kidney],[liver],[anblood],[cancer],[dep],[bp],[ra],[othprob],[othprob1],[othprob2],[othprob3],[othprob4])=0

Exclusion Criteria

REDCap variable: crf01a_desctext4

4. I have joint pain associated with a malignant condition.

REDCap variable: eoi6elig4

*required field

Thank you for your interest in the TIPTOE trial. Unfortunately, you do not meet the criteria to take part in the trial.

REDCap variable: eoi6elig4_warn

Branching logic: [eoi6elig4] = '1'

5. I have had knee and/or hip surgery or joint replacement in the joint causing me the most pain within the last 12 months

REDCap variable: eoi7elig5

*required field

Thank you for your interest in the TIPTOE trial. Unfortunately, you do not meet the criteria to take part in the trial.

REDCap variable: eoi7elig5_warn

Branching logic: [eoi7elig5] = '1'

6. I am living in a care home (residential or nursing care).

REDCap variable: eoi8elig6

*required field

Thank you for your interest in the TIPTOE trial. Unfortunately, you do not meet the criteria to take part in the trial.

REDCap variable: eoi8elig6_warn

Branching logic: [eoi8elig6] = '1'

Your Contact Details

REDCap variable: crf01a_desctext5

REDCap variable: eoi8fname

*required field

Enter a date in d/m/y format, e.g. 01/02/2001, or click the calendar button

REDCap variable: eoi9dob

*required field

REDCap variable: derived_age_01a

Calculated field: datediff("today",[eoi9dob],"y")

Cannot be less than 65 years in the past

REDCap variable: eoi9dob_warn

Branching logic: [derived_age_01a]<65

REDCap variable: eoi10email

*required field

What is your preferred method of contact?

REDCap variable: eoi11contact

*required field

REDCap variable: eoi12phone

*required field

REDCap variable: eoi13add

*required field

REDCap variable: eoi14postcode

*required field

Please could you tell us how you heard about the TIPTOE study?

REDCap variable: eoi15heard

*required field

REDCap variable: eoi15aother

Branching logic: [eoi15heard] = '6'

*required field

Would you like to discuss anything with the study team at this stage?

REDCap variable: eoi16discuss

*required field

A member of the study team will be in touch via email shortly.

REDCap variable: eoi16discuss_warn_2

Branching logic: [eoi16discuss]=1

REDCap variable: eoi16adisc

Branching logic: [eoi16discuss] = '1'

*required field

By completing this expression of interest and eligibility, I confirm that I would like to progress to consent to participate in the TIPTOE trial. I am aware that there is a chance that I will be contacted by the TIPTOE trial team if any additional clarifications are required.

REDCap variable: eoi17confirm1

*required field

I agree the information I have provided in response to the questions will be used by the TIPTOE trial team in reporting the trial results. I am aware that the team will delete all personal data stored in the online system if I do not take part in the trial.

REDCap variable: eoi18confirm2

*required field

Thank you for completing the TIPTOE trial Expression of Interest & Eligibility form. We may contact you shortly, by telephone, if any additional clarifications are required.

REDCap variable: crf01a_desctext6

REDCap variable: crf01a_inclusion_sum

Calculated field: sum([eoi2elig1_1],[eoi3elig2],[eoi4elig3])

REDCap variable: crf01a_exclusion_sum

Calculated field: sum([eoi6elig4],[eoi7elig5],[eoi8elig6])

REDCap variable: crf01a_elig

Calculated field: if([crf01a_inclusion_sum]=3 and [crf01a_exclusion_sum]=0,1,0)

REDCap variable: scqsum

Calculated field: sum([heart],[bpres],[lung],[diab],[ulcer],[kidney],[liver],[anblood],[cancer],[dep],[bp],[ra],[othprob],[othprob1],[othprob2],[othprob3],[othprob4])

REDCap variable: elig_final

Calculated field: if([crf01a_elig]=1 and [scqsum]>=1,1,0)

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Contact the TIPTOE study team:
Email us at: tiptoe@cardiff.ac.uk
Call us on: 02920 688 303
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