Health Coaching for Patients Waiting for Hip or Knee Replacements

Not Applicable

Active, not recruiting

• Conditions: Osteoarthritis, Hip; Osteo Arthritis Knee
• Interventions: Other: Digital Toolkit (Control); Other: Health Coach (Health coaching)

• Registration Number: NCT06101875
• Lead Sponsor: Sheffield Hallam University

Brief 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.

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 Timeline

• Study Start: 2023-08-08
• Study First Submitted: 2023-09-29
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-20
• Last Update Submitted: 2023-10-20
• Study First Posted: 2023-10-26
• Last Update Posted: 2023-10-26
• Primary Completion: 2023-11-14
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Digital Toolkit (Control)	Patients will be enrolled onto the digital toolkit.
Health Coaching	Health Coach (Health coaching)	Patients will be assigned a health coach and be eligible to 8 sessions over a 12 week period.

Primary Outcome Measures

Name	Time	Method
Acceptability of intervention	12 weeks	Will be evaluated by participants feedback via one-to-one semi-structured interviews.
Competition rates	12 weeks	Completion is determined by participants that attend baseline and follow-up testing.
Recruitment Rates	4 weeks	Defined as rate of invited participants who are eligible and consenting.
Retention Rates	12 weeks	Retention rates will be established as discontinuation with the exercise intervention and absence from the assessment sessions.

Secondary Outcome Measures

Name	Time	Method
Change in quality of life	12 weeks	EQ-5D-5L questionnaire (1 - 5 point scale)
Change in patient activation	12 weeks	Patient activation measure 13-item questionnaire (0 - 100 point scale)
Change in pain score	12 weeks	Oxford score questionnaire (0 - 48 point scale)
Change in physical activity	12 weeks	IPAQ-SF questionnaire (MET/mins)

Trial Locations

Locations (1)

Sheffield Hallam University; 🇬🇧 Sheffield, South Yorkshire, United Kingdom