Osteoarthritis, HipNCT06101875
Health Coaching for Patients Waiting for Hip or Knee Replacements
A study testing Health Coach (Health coaching) in people with Osteoarthritis, Hip and Osteo Arthritis Knee, run by Sheffield Hallam University at 1 site in United Kingdom.
Trial summary
A randomised controlled feasibility study of a health coaching intervention targeting people on the waitlist for hip or knee replacement surgery with low patient activation. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Osteoarthritis, Hip, Osteo Arthritis Knee
- What is being tested?
- Health Coach (Health coaching)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Aug 2023to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- On the waitlist for total hip or total knee replacement surgery
- PAM level 1 or 2
Who cannot join
- Current participation in care with a focus on self-management education
- PAM Level 3 or 4
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Hallam University
Sheffield, South Yorkshire, s10 2BP
About this study
Official title: Feasibility of Targeted Health Coaching for Patients With Low Activation Waiting for Total Hip or Total Knee Replacements
A randomised controlled feasibility study of a health coaching intervention targeting people on the waitlist for hip or knee replacement surgery with low patient activation.
Read the detailed description
Determine the feasibility of recruitment and retention to the trial. Evaluate the acceptability of research procedures and outcome measures. Explore the impact of trial participation through patient activation, self-reported health outcomes and interviews.
- Conditions
- Osteoarthritis, Hip, Osteo Arthritis Knee
- Being tested
- Health Coach (Health coaching), Digital Toolkit (Control)
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Coach (Health coaching)Other
Patients will be assigned a health coach and be eligible to 8 times, 1 hour sessions over a 12 week period. The health coach will use techniques to increase their ability to self-manage, motivation levels and commitment to change their behaviour.
Digital Toolkit (Control)Other
This is an online website, unsupervised, 12-week self-management programme.
| Study group | Role | What they receive |
|---|---|---|
| Health Coaching | Experimental | Patients will be assigned a health coach and be eligible to 8 sessions over a 12 week period. Receives: Other: Health Coach (Health coaching) |
| Control | Active comparator | Patients will be enrolled onto the digital toolkit. Receives: Other: Digital Toolkit (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rates
Defined as rate of invited participants who are eligible and consenting.
Measured: 4 weeks
Retention Rates
Retention rates will be established as discontinuation with the exercise intervention and absence from the assessment sessions.
Measured: 12 weeks
Acceptability of intervention
Will be evaluated by participants feedback via one-to-one semi-structured interviews.
Measured: 12 weeks
Competition rates
Completion is determined by participants that attend baseline and follow-up testing.
Measured: 12 weeks
Secondary outcomes (4)
Change in patient activation
Patient activation measure 13-item questionnaire (0 - 100 point scale)
Measured: 12 weeks
Change in quality of life
EQ-5D-5L questionnaire (1 - 5 point scale)
Measured: 12 weeks
Change in pain score
Oxford score questionnaire (0 - 48 point scale)
Measured: 12 weeks
Change in physical activity
IPAQ-SF questionnaire (MET/mins)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start8 Aug 2023
- Primary completion14 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Hallam University
- Sponsor type
- University, hospital or other
- Collaborators
- Sheffield Teaching Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Tom Maden-Wilkinson, PhD, Principal investigator, Sheffield Hallam Unviersity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101875
- Sponsor's protocol ID
- ER53641774
- Status last verified
- Oct 2023
- First submitted
- 29 Sep 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Targeted Health Coaching for Patients With Low Activation Waiting for Total Hip or Total Knee Replacements
- ClinicalTrials.gov ID
- NCT06101875
- Acronym / sponsor ID
- ER53641774
- Conditions
- Osteoarthritis, Hip, Osteo Arthritis Knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sheffield Hallam UniversityUniversity, hospital or other
- Collaborators
- Sheffield Teaching Hospitals NHS Foundation Trust
- Study start
- 8 Aug 2023 (actual)
- Primary completion
- 14 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 26 Oct 2023 (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.
A randomised controlled feasibility study of a health coaching intervention targeting people on the waitlist for hip or knee replacement surgery with low patient activation.
Detailed description
Determine the feasibility of recruitment and retention to the trial. Evaluate the acceptability of research procedures and outcome measures. Explore the impact of trial participation through patient activation, self-reported health outcomes and interviews.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Coaching | Experimental | Other: Health Coach (Health coaching)Patients will be assigned a health coach and be eligible to 8 sessions over a 12 week period. |
| Control | Active comparator | Other: Digital Toolkit (Control)Patients will be enrolled onto the digital toolkit. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- On the waitlist for total hip or total knee replacement surgery
- PAM level 1 or 2
Key exclusion criteria (2 listed)
- Current participation in care with a focus on self-management education
- PAM Level 3 or 4
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 Coach (Health coaching)Patients will be assigned a health coach and be eligible to 8 times, 1 hour sessions over a 12 week period. The health coach will use techniques to increase their ability to self-manage, motivation levels and commitment to change their behaviour. | Other | Health Coaching |
| Digital Toolkit (Control)This is an online website, unsupervised, 12-week self-management programme. | Other | Control |
Primary outcome
Recruitment Rates
Time frame: 4 weeks
Defined as rate of invited participants who are eligible and consenting.
Retention Rates
Time frame: 12 weeks
Retention rates will be established as discontinuation with the exercise intervention and absence from the assessment sessions.
Acceptability of intervention
Time frame: 12 weeks
Will be evaluated by participants feedback via one-to-one semi-structured interviews.
Competition rates
Time frame: 12 weeks
Completion is determined by participants that attend baseline and follow-up testing.
4 secondary outcomes
Change in patient activation
Time frame: 12 weeks
Change in quality of life
Time frame: 12 weeks
Change in pain score
Time frame: 12 weeks
Change in physical activity
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis, Hip
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Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
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Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
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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. This study is not recruiting at the moment.
Tom Maden-Wilkinson, PhD principal investigator
Sheffield Hallam Unviersity
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 Coach (Health coaching) in people with Osteoarthritis, Hip and Osteo Arthritis Knee, 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 26 Oct 2023. 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?
Results are not available in the source record.
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?
Recruitment Rates (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2023.