Health Coaching for Patients Waiting for Hip or Knee Replacements

Sponsor
Sheffield Hallam University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06101875
Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust (Other)
50
1
2
3.7
13.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Health Coach (Health coaching)
  • Other: Digital Toolkit (Control)
N/A

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

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Feasibility of Targeted Health Coaching for Patients With Low Activation Waiting for Total Hip or Total Knee Replacements
Actual Study Start Date :
Aug 8, 2023
Anticipated Primary Completion Date :
Nov 14, 2023
Anticipated Study Completion Date :
Nov 30, 2023

Arms and Interventions

Arm Intervention/Treatment
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)
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.

Active Comparator: Control

Patients will be enrolled onto the digital toolkit.

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

Outcome Measures

Primary Outcome Measures

  1. Recruitment Rates [4 weeks]

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

  2. Retention Rates [12 weeks]

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

  3. Acceptability of intervention [12 weeks]

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

  4. Competition rates [12 weeks]

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

Secondary Outcome Measures

  1. Change in patient activation [12 weeks]

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

  2. Change in quality of life [12 weeks]

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

  3. Change in pain score [12 weeks]

    Oxford score questionnaire (0 - 48 point scale)

  4. Change in physical activity [12 weeks]

    IPAQ-SF questionnaire (MET/mins)

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sheffield Hallam University Sheffield South Yorkshire United Kingdom s10 2BP

Sponsors and Collaborators

  • Sheffield Hallam University
  • Sheffield Teaching Hospitals NHS Foundation Trust

Investigators

  • Principal Investigator: Tom Maden-Wilkinson, PhD, Sheffield Hallam Unviersity

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sheffield Hallam University
ClinicalTrials.gov Identifier:
NCT06101875
Other Study ID Numbers:
  • ER53641774
First Posted:
Oct 26, 2023
Last Update Posted:
Oct 26, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 26, 2023