Health Coaching for Patients Waiting for Hip or Knee Replacements

October 20, 2023 updated by: Sheffield Hallam University

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S10 2BP
        • Sheffield Hallam University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheffield Hallam University

Collaborators

Sheffield Teaching Hospitals NHS Foundation Trust

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2023

Primary Completion (Estimated)

November 14, 2023

Study Completion (Estimated)

November 30, 2023

Study Registration Dates

First Submitted

September 29, 2023

First Submitted That Met QC Criteria

October 20, 2023

First Posted (Actual)

October 26, 2023

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 20, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ER53641774

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteo Arthritis Knee

Clinical Trials on Health Coach (Health coaching)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe