Feasibility of the use of a 'barometer of foot health' for arthritis

Acceptability and feasibility of the use of a 'barometer of foot health needs' in primary care to signpost people who have arthritis towards appropriate foot health management.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13564562

Enrollment

Registered

2020-01-22

Start date

2020-01-22

Completion date

Unknown

Last updated

2021-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis Musculoskeletal Diseases Osteoarthritis

Interventions

The OptiFooT study is a feasibility study for a future multi-centred parallel-group randomised superiority trial with 3-month follow-up. The feasibility study has been designed through findings from t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18 or older 2. Accessing their GP practice with an episode of foot pain 3. Have clinician diagnosed OA (ie OA documented as a medical condition affecting their knees, hips, hands or feet). 4. Be literate in English and able to complete the questionnaires and pain diary used in this study 5. Be willing to complete follow up questionnaires at 3 months 6. Living in the Wessex region

Exclusion criteria

Exclusion criteria: 1. Inflammatory arthritis (e.g. rheumatoid arthritis) 2. Foot and/or ankle ulceration 3. Currently under the care of a foot and ankle surgeon or awaiting foot and ankle surgery

Design outcomes

Primary

Measure	Time frame
1. Referral rates and patterns assessed by the total number of referrals, where/who the referrals were to and tests related to foot pain requested by GPs/practice staff throughout the study period. 2. The measurement properties (responsiveness, minimal important difference) of different candidate outcome measures for foot pain, to identify and select the most suitable primary outcome measure for the main trial. Measured using participant self-report questionnaires 3. The acceptability of the ‘optimal foot health services information pack’ intervention, assessed by telephone interview with a subsample (n=2-3) of participants at 6 months (i.e. end of study period) 4. The acceptability of participating GPs delivering the ‘optimal foot health services information pack’ intervention as intended, assessed by debrief study evaluation at end of study period 5. The length of time to run the trial will be evaluated. Three-month follow-up was chosen in this feasibility study to allow sufficient time for referrals to be established, however it may be that 3-months is not long enough to assess clinically meaningful change in foot pain	—

Measure

Time frame

1. Referral rates and patterns assessed by the total number of referrals, where/who the referrals were to and tests related to foot pain requested by GPs/practice staff throughout the study period. 2. The measurement properties (responsiveness, minimal important difference) of different candidate outcome measures for foot pain, to identify and select the most suitable primary outcome measure for the main trial. Measured using participant self-report questionnaires 3. The acceptability of the ‘optimal foot health services information pack’ intervention, assessed by telephone interview with a subsample (n=2-3) of participants at 6 months (i.e. end of study period) 4. The acceptability of participating GPs delivering the ‘optimal foot health services information pack’ intervention as intended, assessed by debrief study evaluation at end of study period 5. The length of time to run the trial will be evaluated. Three-month follow-up was chosen in this feasibility study to allow sufficient time for referrals to be established, however it may be that 3-months is not long enough to assess clinically meaningful change in foot pain

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Secondary

Measure	Time frame
1. The effect of an ‘optimal foot health services information pack’ on foot symptom reduction measured by a self-reported questionnaire at baseline, four weeks and twelve weeks 2. Foot pain and disability measured using the Manchester Foot Pain and Disability Index (MFPDI) at baseline, four weeks and twelve weeks 3. Referral to other clinicians, referral time to be seen, self-reported early life and current foot and knee alignment, footwear type and footwear habits assessed by self-reported questionnaire at baseline, four weeks and twelve weeks 4. Levels of physical activity, effect of osteoarthritis (joint site/s, history, surgical history, and current medications), and any other medical conditions assessed by self-reported questionnaire at baseline, four weeks and twelve weeks	—

Measure

Time frame

1. The effect of an ‘optimal foot health services information pack’ on foot symptom reduction measured by a self-reported questionnaire at baseline, four weeks and twelve weeks 2. Foot pain and disability measured using the Manchester Foot Pain and Disability Index (MFPDI) at baseline, four weeks and twelve weeks 3. Referral to other clinicians, referral time to be seen, self-reported early life and current foot and knee alignment, footwear type and footwear habits assessed by self-reported questionnaire at baseline, four weeks and twelve weeks 4. Levels of physical activity, effect of osteoarthritis (joint site/s, history, surgical history, and current medications), and any other medical conditions assessed by self-reported questionnaire at baseline, four weeks and twelve weeks

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Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026