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Status unknownNCT06101875Updated Oct 26, 2023

Health Coaching for Patients Waiting for Hip or Knee Replacements

An interventional study of Health Coach (Health coaching) and Digital Toolkit (Control) in Osteoarthritis, Hip and Osteo Arthritis Knee, sponsored by Sheffield Hallam University. Status unknown at 1 site in United Kingdom. Open to participants aged 30 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-10-26.

Sponsored by Sheffield Hallam University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2023), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
30 Years to 90 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Osteoarthritis, Hip
  • Osteo Arthritis Knee

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03

In context

Osteoarthritis, Hip

642 studies on the registry are indexed under Osteoarthritis, Hip; 122 are open to participants now.

This study's enrollment of 50 is below the median of 90 across 458 interventional studies indexed under Osteoarthritis, Hip.

Browse Osteoarthritis, Hip studies →

Lead sponsor

Sheffield Hallam University is the lead sponsor of 48 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • On the waitlist for total hip or total knee replacement surgery
  • PAM level 1 or 2

Exclusion criteria

Exclusion Criteria:

  • Current participation in care with a focus on self-management education
  • PAM Level 3 or 4
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Health Coaching

    Patients will be assigned a health coach and be eligible to 8 sessions over a 12 week period.

    Other: Health Coach (Health coaching)

  • Active comparator
    Control

    Patients will be enrolled onto the digital toolkit.

    Other: Digital Toolkit (Control)

Interventions

  • OtherHealth 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.

  • OtherDigital Toolkit (Control)

    This is an online website, unsupervised, 12-week self-management programme.

06

What researchers measure

Primary outcomes

  1. Recruitment Rates

    Defined as rate of invited participants who are eligible and consenting.

    Time frame: 4 weeks

  2. Retention Rates

    Retention rates will be established as discontinuation with the exercise intervention and absence from the assessment sessions.

    Time frame: 12 weeks

  3. Acceptability of intervention

    Will be evaluated by participants feedback via one-to-one semi-structured interviews.

    Time frame: 12 weeks

  4. Competition rates

    Completion is determined by participants that attend baseline and follow-up testing.

    Time frame: 12 weeks

Secondary outcomes

  1. Change in patient activation

    Patient activation measure 13-item questionnaire (0 - 100 point scale)

    Time frame: 12 weeks

  2. Change in quality of life

    EQ-5D-5L questionnaire (1 - 5 point scale)

    Time frame: 12 weeks

  3. Change in pain score

    Oxford score questionnaire (0 - 48 point scale)

    Time frame: 12 weeks

  4. Change in physical activity

    IPAQ-SF questionnaire (MET/mins)

    Time frame: 12 weeks

07

Study locations

1 site
  • Sheffield Hallam University
    Sheffield, South Yorkshire s10 2BP, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2023 (actual). Primary completion is estimated for Nov 2023, 3 months after the start.

Of 197 non-industry interventional studies with no phase under Osteoarthritis, Hip, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 45. This study's planned 3 months is below that.

Counting every sponsor, half of 224 studies reached it within 29 months; a quarter within 14 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 29, 2023
First posted
Oct 26, 2023
StartActual
Aug 8, 2023
Primary completionEst.
Nov 14, 2023
CompletionEst.
Nov 30, 2023
Last update
Oct 26, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06101875
Lead sponsor
Sheffield Hallam University
Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
Responsible party
Sponsor
First posted
Oct 26, 2023
Start date
Aug 8, 2023
Primary completion
Nov 14, 2023 (estimated)
Completion
Nov 30, 2023 (estimated)
Last update
Oct 26, 2023

Study contacts

Tom Maden-Wilkinson, PhD
principal investigator · Sheffield Hallam Unviersity

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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