Arthritis KneeNCT06596031
Health Coaching for Patients Waiting for Total Hip or Knee Replacements
A study testing Health coaching and Digital toolkit in people with Arthritis Knee and Arthritis of Hip, run by Sheffield Hallam University at 1 site in United Kingdom.
Trial summary
This pilot study aims to evaluate the feasibility of collecting objective data on physical performance to measure the impact of health coaching in addition to a digital resource (Active Wait) and enable sample size calculation for a larger scale RCT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis Knee, Arthritis of Hip
- What is being tested?
- Health coaching and Digital toolkit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Feb 2025to Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scheduled on the waitlist for a total joint replacement surgery for hip/knee, ie clinically and radiographically diagnosed, symptomatic knee/hip osteoarthritis deemed suitable for surgical intervention;
- have access to the internet and the ability to navigate web-based programs;
- able and willing to travel to Advanced Wellbeing Research Centre for baseline and follow-up assessments;
- able to comprehend the requirements and purpose of the study and give informed consent
Who cannot join
- other musculoskeletal lower limb or back conditions requiring assessment or treatment by a health professional in the last 6 months;
- neurological impairment or condition affecting lower limb function; conditions listed as both absolute and relative contraindications for physical activities by the American College of Sports Medicine (ACSM), such as unstable angina, uncontrolled diabetes;
- systemic inflammatory disease (e.g. rheumatoid arthritis);
- previous total joint replacement surgery (hip or knee)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Advanced Wellbeing Research Centre
Sheffield, S9 3TU
About this study
Official title: Health Coaching in Addition to a Digital Resource to Promote Self-management for Patients Waiting for Total Hip or Knee Replacements: A Randomised Feasibility Trial
This pilot study aims to evaluate the feasibility of collecting objective data on physical performance to measure the impact of health coaching in addition to a digital resource (Active Wait) and enable sample size calculation for a larger scale RCT.
- Conditions
- Arthritis Knee, Arthritis of Hip
- Being tested
- Health coaching, Digital toolkit
- Keywords
- joint replacement surgery, digital resource, health coaching, telehealth, self management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health coachingBehavioural
The core belief in coaching is that people are resourceful and that the participant knows what is best for themselves. If the participants are assigned to the health coaching group, they will have access to a health coach with a physiotherapist background. Instead of offering physiotherapy advice, however, the health coaching will work with the participant to come up with ideas that work the best for them to manage their health and wellness to prepare for surgery, including addressing some difficulties the participant are facing when using the online resource.
Digital toolkitBehavioural
This intervention provides, via a website, self-management support of preoperative rehabilitation for hip or knee replacement based on NICE guidelines Joint replacement (primary): hip and knee. This includes guidance for patients to undertake a strengthening programme that will aid recovery, lifestyle behaviours including weight management, diet and smoking cessation, and maximising functional independence and quality of life before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Health coaching | Experimental | Participants randomized to the intervention group will receive access to the Active Wait program, which includes remote, self-paced (asynchronous) education, exercise, and nutritional advice delivered via a web-based platform. The participants in the intervention group will have access to the program, in conjunction with health coaching.
Patients undertaking health coaching will be assigned a personal health coach who will provide support to increase their ability to self-manage through self- regulation principles of behaviour change. Health coaching sessions will be delivered remotely (via telephone or video conferencing) a maximum of 8-times during a 12-week intervention period. Sessions are limited to 1 hour, offering education, self-management strategies, barrier and facilitator identification, support and encouragement, goal setting, action planning and self-monitoring with the intention to facilitate positive and sustainable lifestyle and behaviour changes. Receives: Behavioral: Health coaching |
| Digital toolkit | Active comparator | Patients in the active-comparator group will be given a link to the same Digital Toolkit. The digital toolkit is a 12-week non-contact programme titled Active Wait, which offers education, self-management techniques and an unsupervised strength programme. The website Active Wait can be accessed via the link: https://protect-au.mimecast.com/s/8_5gCP7yRZiWn3q3FzwqnS?domain=sheffieldachesandpains.com/ Receives: Behavioral: Digital toolkit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global rating of change
Bowens Framework - acceptability (Perceived benefits) 7-point likert scale global rating of change (GROC) with -3 being worse, 0 being no change and 3 being better
Measured: 12 weeks
Perceived Satisfaction
Bowens Framework - acceptability (Perceived satisfaction). How satisfied were you with the overall information, level of support, and ease of use of the program? Measured on a numeric rating scale, where 0 means not satisfied, 10 means significant satisfaction.
Measured: 12 weeks
Rate of retention
Bowens Framework - acceptability, percentage of participants progressing from baseline, to midpoint and post-intervention assessments
Measured: 12 weeks
Drop out rate
Bowens Framework - acceptability, percentage of people discontinuing in both groups
Measured: 12 weeks
Adverse events
Bowens Framework- practicality, measured by number, type and severity of adverse events
Measured: 12 weeks
Rate of service utilisation
Bowens Framework - implementation, measured by the number of attended sessions (health coaching) number of days during the week using the active wait website
Measured: 12 weeks
Rates of recruitment
Bowens Framework - demand, measured by n number of recruitment per week.
Measured: 12 weeks
Secondary outcomes (12)
Demographics
height and weight aggregated to arrive at one reported value BMI, in units kg/m^2
Measured: 12 weeks
Arthritis Self-Efficacy Scale (ASES-8)
Self efficacy questionnaire. Contains 8 items, each measured on a scale from 1-10. Higher score indicates greater self-efficacy.
Measured: 12 weeks
International physical activity questionnaire-short form (IPAQ-SF)
Physical activity level is measured in three categories, walking, moderate-intensity activities, vigorous-intensity activities, in addition to sitting. Their score is then expressed as MET-min per week.
Measured: 12 weeks
EuroQoL Group's 5-dimension (EQ-5D-5L)
Health related quality of life questionnaire. Each dimension of the EQ-5D has 5 levels from 1-5. 1 indicates full health state, 5 indicates worse the problem. The last question, EQ-5D health scale is a scale between 0-100, where 0 indicates worst health, 100 indicates best health.
Measured: 12 week
Visual Analogue Scale
VAS 10 point scale for self report of pain level. With 1 being no pain and 10 being maximal pain.
Measured: 12 week
Oxford knee/hip score
Joint specific function questionnaire. The questionnaire contains 6 questions. Each question ranges from 0 to 4, with 4 being the best outcome. The highest score is 48.
Measured: 12 week
Knee flexion/extension strength
Biodex for isometric strength testing, peak torque will be calculated in N.m
Measured: 12 week
4 x 10m walk test
The average time taken to complete a 10m lap (s)
Measured: 12 week
12 steps test
Time taken to complete 1 flight of 12 steps (s)
Measured: 12 week
Time up and go
Amount of time taken to complete a lap from sitting to standing, walking for 3 m, turn around a marker and return to sitting position (s)
Measured: 12 week
Sit to stand test
Number of full repetitions from sitting to standing in a 30s period
Measured: 12 week
Minutes in sedentary activities
Wearable tracking using ActivPAL
Measured: 1 week baseline and 1 week at completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start27 Feb 2025
- Primary completionAug 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Arthritis KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot study of a single-blinded, randomised controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Hallam University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596031
- Sponsor's protocol ID
- ER68359613
- Status last verified
- May 2025
- First submitted
- 4 Sep 2024
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a pilot study assessing the feasibility of conducting a larger scale randomised control trial. Limited efficacy is the secondary outcome only.
Publications
Abbott JH, Schmitt J. Minimum important differences for the patient-specific functional scale, 4 region-specific outcome measures, and the numeric pain rating scale. J Orthop Sports Phys Ther. 2014 Aug;44(8):560-4. doi: 10.2519/jospt.2014.5248. Epub 2014 May 14.
PubMed 24828475Bowen DJ, Kreuter M, Spring B, Cofta-Woerpel L, Linnan L, Weiner D, Bakken S, Kaplan CP, Squiers L, Fabrizio C, Fernandez M. How we design feasibility studies. Am J Prev Med. 2009 May;36(5):452-7. doi: 10.1016/j.amepre.2009.02.002.
PubMed 19362699Bull FC, Al-Ansari SS, Biddle S, Borodulin K, Buman MP, Cardon G, Carty C, Chaput JP, Chastin S, Chou R, Dempsey PC, DiPietro L, Ekelund U, Firth J, Friedenreich CM, Garcia L, Gichu M, Jago R, Katzmarzyk PT, Lambert E, Leitzmann M, Milton K, Ortega FB, Ranasinghe C, Stamatakis E, Tiedemann A, Troiano RP, van der Ploeg HP, Wari V, Willumsen JF. World Health Organization 2020 guidelines on physical activity and sedentary behaviour. Br J Sports Med. 2020 Dec;54(24):1451-1462. doi: 10.1136/bjsports-2020-102955.
PubMed 33239350Dobson F, Hinman RS, Roos EM, Abbott JH, Stratford P, Davis AM, Buchbinder R, Snyder-Mackler L, Henrotin Y, Thumboo J, Hansen P, Bennell KL. OARSI recommended performance-based tests to assess physical function in people diagnosed with hip or knee osteoarthritis. Osteoarthritis Cartilage. 2013 Aug;21(8):1042-52. doi: 10.1016/j.joca.2013.05.002. Epub 2013 May 13.
PubMed 23680877Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004 May;10(2):307-12. doi: 10.1111/j..2002.384.doc.x.
PubMed 15189396Lee PH, Macfarlane DJ, Lam TH, Stewart SM. Validity of the International Physical Activity Questionnaire Short Form (IPAQ-SF): a systematic review. Int J Behav Nutr Phys Act. 2011 Oct 21;8:115. doi: 10.1186/1479-5868-8-115.
PubMed 22018588Lienhard K, Lauermann SP, Schneider D, Item-Glatthorn JF, Casartelli NC, Maffiuletti NA. Validity and reliability of isometric, isokinetic and isoinertial modalities for the assessment of quadriceps muscle strength in patients with total knee arthroplasty. J Electromyogr Kinesiol. 2013 Dec;23(6):1283-8. doi: 10.1016/j.jelekin.2013.09.004. Epub 2013 Sep 23.
PubMed 24113423Lorig K, Chastain RL, Ung E, Shoor S, Holman HR. Development and evaluation of a scale to measure perceived self-efficacy in people with arthritis. Arthritis Rheum. 1989 Jan;32(1):37-44. doi: 10.1002/anr.1780320107.
PubMed 2912463Lyden K, Keadle SK, Staudenmayer J, Freedson PS. The activPALTM Accurately Classifies Activity Intensity Categories in Healthy Adults. Med Sci Sports Exerc. 2017 May;49(5):1022-1028. doi: 10.1249/MSS.0000000000001177.
PubMed 28410327Norman R, Cronin P, Viney R. A pilot discrete choice experiment to explore preferences for EQ-5D-5L health states. Appl Health Econ Health Policy. 2013 Jun;11(3):287-98. doi: 10.1007/s40258-013-0035-z.
PubMed 23649892Sarabon N, Ceh T, Kozinc Z, Smajla D. Adapted protocol of rate of force development and relaxation scaling factor for neuromuscular assessment in patients with knee osteoarthritis. Knee. 2020 Dec;27(6):1697-1707. doi: 10.1016/j.knee.2020.09.023. Epub 2020 Nov 13.
PubMed 33197807Sekhon M, Cartwright M, Francis JJ. Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC Health Serv Res. 2017 Jan 26;17(1):88. doi: 10.1186/s12913-017-2031-8.
PubMed 28126032Wallis JA, Webster KE, Levinger P, Taylor NF. What proportion of people with hip and knee osteoarthritis meet physical activity guidelines? A systematic review and meta-analysis. Osteoarthritis Cartilage. 2013 Nov;21(11):1648-59. doi: 10.1016/j.joca.2013.08.003. Epub 2013 Aug 12.
PubMed 23948979Wilcox S, Schoffman DE, Dowda M, Sharpe PA. Psychometric properties of the 8-item english arthritis self-efficacy scale in a diverse sample. Arthritis. 2014;2014:385256. doi: 10.1155/2014/385256. Epub 2014 Aug 21.
PubMed 25215233
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Coaching in Addition to a Digital Resource to Promote Self-management for Patients Waiting for Total Hip or Knee Replacements: A Randomised Feasibility Trial
- ClinicalTrials.gov ID
- NCT06596031
- Acronym / sponsor ID
- ER68359613
- Conditions
- Arthritis Knee, Arthritis of Hip
- Keywords
- joint replacement surgery, digital resource, health coaching, telehealth, self management
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Sheffield Hallam UniversityUniversity, hospital or other
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study aims to evaluate the feasibility of collecting objective data on physical performance to measure the impact of health coaching in addition to a digital resource (Active Wait) and enable sample size calculation for a larger scale RCT.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pilot study of a single-blinded, randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Health coaching | Experimental | Behavioral: Health coachingParticipants randomized to the intervention group will receive access to the Active Wait program, which includes remote, self-paced (asynchronous) education, exercise, and nutritional advice delivered via a web-based platform. The participants in the intervention group will have access to the program, in conjunction with health coaching. Patients undertaking health coaching will be assigned a personal health coach who will provide support to increase their ability to self-manage through self- regulation principles of behaviour change. Health coaching sessions will be delivered remotely (via telephone or video conferencing) a maximum of 8-times during a 12-week intervention period. Sessions are limited to 1 hour, offering education, self-management strategies, barrier and facilitator identification, support and encouragement, goal setting, action planning and self-monitoring with the intention to facilitate positive and sustainable lifestyle and behaviour changes. |
| Digital toolkit | Active comparator | Behavioral: Digital toolkitPatients in the active-comparator group will be given a link to the same Digital Toolkit. The digital toolkit is a 12-week non-contact programme titled Active Wait, which offers education, self-management techniques and an unsupervised strength programme. The website Active Wait can be accessed via the link: https://protect-au.mimecast.com/s/8_5gCP7yRZiWn3q3FzwqnS?domain=sheffieldachesandpains.com/ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients scheduled on the waitlist for a total joint replacement surgery for hip/knee, ie clinically and radiographically diagnosed, symptomatic knee/hip osteoarthritis deemed suitable for surgical intervention;
- have access to the internet and the ability to navigate web-based programs;
- able and willing to travel to Advanced Wellbeing Research Centre for baseline and follow-up assessments;
- able to comprehend the requirements and purpose of the study and give informed consent
Key exclusion criteria (4 listed)
- other musculoskeletal lower limb or back conditions requiring assessment or treatment by a health professional in the last 6 months;
- neurological impairment or condition affecting lower limb function; conditions listed as both absolute and relative contraindications for physical activities by the American College of Sports Medicine (ACSM), such as unstable angina, uncontrolled diabetes;
- systemic inflammatory disease (e.g. rheumatoid arthritis);
- previous total joint replacement surgery (hip or knee)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health coachingThe core belief in coaching is that people are resourceful and that the participant knows what is best for themselves. If the participants are assigned to the health coaching group, they will have access to a health coach with a physiotherapist background. Instead of offering physiotherapy advice, however, the health coaching will work with the participant to come up with ideas that work the best for them to manage their health and wellness to prepare for surgery, including addressing some difficulties the participant are facing when using the online resource. | Behavioural | Health coaching |
| Digital toolkitThis intervention provides, via a website, self-management support of preoperative rehabilitation for hip or knee replacement based on NICE guidelines Joint replacement (primary): hip and knee. This includes guidance for patients to undertake a strengthening programme that will aid recovery, lifestyle behaviours including weight management, diet and smoking cessation, and maximising functional independence and quality of life before surgery. | Behavioural | Digital toolkit |
Primary outcome
Global rating of change
Time frame: 12 weeks
Bowens Framework - acceptability (Perceived benefits) 7-point likert scale global rating of change (GROC) with -3 being worse, 0 being no change and 3 being better
Perceived Satisfaction
Time frame: 12 weeks
Bowens Framework - acceptability (Perceived satisfaction). How satisfied were you with the overall information, level of support, and ease of use of the program? Measured on a numeric rating scale, where 0 means not satisfied, 10 means significant satisfaction.
Rate of retention
Time frame: 12 weeks
Bowens Framework - acceptability, percentage of participants progressing from baseline, to midpoint and post-intervention assessments
Drop out rate
Time frame: 12 weeks
Bowens Framework - acceptability, percentage of people discontinuing in both groups
Adverse events
Time frame: 12 weeks
Bowens Framework- practicality, measured by number, type and severity of adverse events
Rate of service utilisation
Time frame: 12 weeks
Bowens Framework - implementation, measured by the number of attended sessions (health coaching) number of days during the week using the active wait website
Rates of recruitment
Time frame: 12 weeks
Bowens Framework - demand, measured by n number of recruitment per week.
12 secondary outcomes
Demographics
Time frame: 12 weeks
Arthritis Self-Efficacy Scale (ASES-8)
Time frame: 12 weeks
International physical activity questionnaire-short form (IPAQ-SF)
Time frame: 12 weeks
EuroQoL Group's 5-dimension (EQ-5D-5L)
Time frame: 12 week
Visual Analogue Scale
Time frame: 12 week
Oxford knee/hip score
Time frame: 12 week
Knee flexion/extension strength
Time frame: 12 week
4 x 10m walk test
Time frame: 12 week
12 steps test
Time frame: 12 week
Time up and go
Time frame: 12 week
Sit to stand test
Time frame: 12 week
Minutes in sedentary activities
Time frame: 1 week baseline and 1 week at completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Background: PubMed 24828475Abbott JH, Schmitt J. Minimum important differences for the patient-specific functional scale, 4 region-specific outcome measures, and the numeric pain rating scale. J Orthop Sports Phys Ther. 2014 Aug;44(8):560-4. doi: 10.2519/jospt.2014.5248. Epub 2014 May 14.
- Background: PubMed 19362699Bowen DJ, Kreuter M, Spring B, Cofta-Woerpel L, Linnan L, Weiner D, Bakken S, Kaplan CP, Squiers L, Fabrizio C, Fernandez M. How we design feasibility studies. Am J Prev Med. 2009 May;36(5):452-7. doi: 10.1016/j.amepre.2009.02.002.
- Background: PubMed 33239350Bull FC, Al-Ansari SS, Biddle S, Borodulin K, Buman MP, Cardon G, Carty C, Chaput JP, Chastin S, Chou R, Dempsey PC, DiPietro L, Ekelund U, Firth J, Friedenreich CM, Garcia L, Gichu M, Jago R, Katzmarzyk PT, Lambert E, Leitzmann M, Milton K, Ortega FB, Ranasinghe C, Stamatakis E, Tiedemann A, Troiano RP, van der Ploeg HP, Wari V, Willumsen JF. World Health Organization 2020 guidelines on physical activity and sedentary behaviour. Br J Sports Med. 2020 Dec;54(24):1451-1462. doi: 10.1136/bjsports-2020-102955.
- Background: PubMed 23680877Dobson F, Hinman RS, Roos EM, Abbott JH, Stratford P, Davis AM, Buchbinder R, Snyder-Mackler L, Henrotin Y, Thumboo J, Hansen P, Bennell KL. OARSI recommended performance-based tests to assess physical function in people diagnosed with hip or knee osteoarthritis. Osteoarthritis Cartilage. 2013 Aug;21(8):1042-52. doi: 10.1016/j.joca.2013.05.002. Epub 2013 May 13.
- Background: PubMed 15189396Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004 May;10(2):307-12. doi: 10.1111/j..2002.384.doc.x.
- Background: PubMed 22018588Lee PH, Macfarlane DJ, Lam TH, Stewart SM. Validity of the International Physical Activity Questionnaire Short Form (IPAQ-SF): a systematic review. Int J Behav Nutr Phys Act. 2011 Oct 21;8:115. doi: 10.1186/1479-5868-8-115.
- Background: PubMed 24113423Lienhard K, Lauermann SP, Schneider D, Item-Glatthorn JF, Casartelli NC, Maffiuletti NA. Validity and reliability of isometric, isokinetic and isoinertial modalities for the assessment of quadriceps muscle strength in patients with total knee arthroplasty. J Electromyogr Kinesiol. 2013 Dec;23(6):1283-8. doi: 10.1016/j.jelekin.2013.09.004. Epub 2013 Sep 23.
- Background: PubMed 2912463Lorig K, Chastain RL, Ung E, Shoor S, Holman HR. Development and evaluation of a scale to measure perceived self-efficacy in people with arthritis. Arthritis Rheum. 1989 Jan;32(1):37-44. doi: 10.1002/anr.1780320107.
- Background: PubMed 28410327Lyden K, Keadle SK, Staudenmayer J, Freedson PS. The activPALTM Accurately Classifies Activity Intensity Categories in Healthy Adults. Med Sci Sports Exerc. 2017 May;49(5):1022-1028. doi: 10.1249/MSS.0000000000001177.
- Background: PubMed 23649892Norman R, Cronin P, Viney R. A pilot discrete choice experiment to explore preferences for EQ-5D-5L health states. Appl Health Econ Health Policy. 2013 Jun;11(3):287-98. doi: 10.1007/s40258-013-0035-z.
- Background: PubMed 33197807Sarabon N, Ceh T, Kozinc Z, Smajla D. Adapted protocol of rate of force development and relaxation scaling factor for neuromuscular assessment in patients with knee osteoarthritis. Knee. 2020 Dec;27(6):1697-1707. doi: 10.1016/j.knee.2020.09.023. Epub 2020 Nov 13.
- Background: PubMed 28126032Sekhon M, Cartwright M, Francis JJ. Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC Health Serv Res. 2017 Jan 26;17(1):88. doi: 10.1186/s12913-017-2031-8.
- Individual participant dataSharing planned: No. This is a pilot study assessing the feasibility of conducting a larger scale randomised control trial. Limited efficacy is the secondary outcome only.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health coaching and Digital toolkit in people with Arthritis Knee and Arthritis of Hip, run by Sheffield Hallam University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global rating of change (time frame: 12 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06596031, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.