NCT06101875

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 8, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2023

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

September 29, 2023

Last Update Submit

October 20, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • Recruitment Rates

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

    4 weeks

  • Retention Rates

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

    12 weeks

  • Acceptability of intervention

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

    12 weeks

  • Competition rates

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

    12 weeks

Secondary Outcomes (4)

  • Change in patient activation

    12 weeks

  • Change in quality of life

    12 weeks

  • Change in pain score

    12 weeks

  • Change in physical activity

    12 weeks

Study Arms (2)

Health Coaching

EXPERIMENTAL

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

Other: Health Coach (Health coaching)

Control

ACTIVE COMPARATOR

Patients will be enrolled onto the digital toolkit.

Other: Digital Toolkit (Control)

Interventions

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.

Health Coaching

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

Control

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheffield Hallam University

Sheffield, South Yorkshire, s10 2BP, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Tom Maden-Wilkinson, PhD

    Sheffield Hallam Unviersity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2023

First Posted

October 26, 2023

Study Start

August 8, 2023

Primary Completion

November 14, 2023

Study Completion

November 30, 2023

Last Updated

October 26, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations