Health Coaching for Patients Waiting for Hip or Knee Replacements

Osteoarthritis, Hip Clinical Trial

Official title:

Feasibility of Targeted Health Coaching for Patients With Low Activation Waiting for Total Hip or Total Knee Replacements

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06101875
• Other study ID #: ER53641774
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 8, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: October 2023
• Source: Sheffield Hallam University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: November 30, 2023
• Est. primary completion date: November 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 90 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee

Intervention

Other:
• 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.
• Digital Toolkit (Control)
This is an online website, unsupervised, 12-week self-management programme.

Locations

Country	Name	City	State
United Kingdom	Sheffield Hallam University	Sheffield	South Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
Sheffield Hallam University	Sheffield Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Rates	Defined as rate of invited participants who are eligible and consenting.	4 weeks
Primary	Retention Rates	Retention rates will be established as discontinuation with the exercise intervention and absence from the assessment sessions.	12 weeks
Primary	Acceptability of intervention	Will be evaluated by participants feedback via one-to-one semi-structured interviews.	12 weeks
Primary	Competition rates	Completion is determined by participants that attend baseline and follow-up testing.	12 weeks
Secondary	Change in patient activation	Patient activation measure 13-item questionnaire (0 - 100 point scale)	12 weeks
Secondary	Change in quality of life	EQ-5D-5L questionnaire (1 - 5 point scale)	12 weeks
Secondary	Change in pain score	Oxford score questionnaire (0 - 48 point scale)	12 weeks
Secondary	Change in physical activity	IPAQ-SF questionnaire (MET/mins)	12 weeks