NCT03559205

Brief Summary

This study will co-design and test the feasibility and impact of implementing the Arthritis Research UK Musculoskeletal Health Questionnaire (MSK-HQ) using an e-PROM (electronic Patient Reported Outcome Measure) delivered via a digital health platform, with innovative embedded components called the MSK-Tracker. The MSK-Tracker uses the MSK-HQ as a foundation to help patients with MSK pain to:

  • track the extent to which they are affected by their MSK condition across different aspects of their health,
  • prepare appropriately for their clinical encounters, and
  • take the right steps to making positive changes to improve their quality of life and manage their condition over the longer-term. The Study Aims to:
  • Test the ability of the MSK-Tracker to act as an empowerment tool and method of facilitating a person-centred care planning approach in routine MSK clinic consultations.
  • Assess the value of the MSK-Tracker in generating aggregated outputs that inform MSK service improvement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
321

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 17, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 18, 2018

Completed
22 days until next milestone

Study Start

First participant enrolled

July 10, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

November 10, 2021

Completed
Last Updated

November 10, 2021

Status Verified

October 1, 2021

Enrollment Period

12 months

First QC Date

April 17, 2018

Results QC Date

July 7, 2021

Last Update Submit

October 13, 2021

Conditions

Keywords

MusculoskeletalMSK

Outcome Measures

Primary Outcomes (1)

  • Patient Enablement Instrument (PEI)

    A measure of patient empowerment. Scale: Much better / Much more = 2 Better / More = 1 Same or less = 0 Not applicable = 9

    2 weeks

Secondary Outcomes (5)

  • Musculoskeletal Health Questionnaire (MSK-HQ)

    Baseline, 2 weeks and 3 months

  • Consumer Health Activation Index (CHAI)

    Baseline, 2 weeks and 3 months

  • Valuing Patients as Individuals Scale (Short Version)

    2 weeks

  • Global Rating of Change (1 Item)

    2 weeks and 3 months

  • The Patient Enablement Scale

    3 months

Study Arms (2)

MSK-Tracker (before)

NO INTERVENTION

Before - (Usual care in clinic consultations)

MSK-Tracker (after)

ACTIVE COMPARATOR

After - (MSK-Tracker in clinic consultations)

Other: MSK-Tracker

Interventions

The intervention is not a treatment, but involves patients and clinicians engaging with the MSK-Tracker software which will facilitate a new care planning approach with the following distinct components: * Pre-clinic preparation. * Clinic dashboard. * Summary action plan. * Personal goal setting. * Follow-up and monitoring.

MSK-Tracker (after)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 years and above with an appointment to attend the Staffordshire Musculoskeletal Interface Service for an MSK pain problem will be invited to take part.

You may not qualify if:

  • Patients unable to use or access the internet will be unable to take part in this research as well as patients who do not provide informed consent for study participation and data collection. The online system will only be available in English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haywood Hospital

Stoke-on-Trent, Staffordshire, ST6 7AG, United Kingdom

Location

MeSH Terms

Conditions

Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

This project was limited to a single clinical site and to the specific context of an interface clinic setting in between community care and secondary care services within the NHS.

Results Point of Contact

Title
Jonathan Hill
Organization
Keele University

Study Officials

  • Jonathan Hill, Dr

    Keele University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: Before and after comparative study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2018

First Posted

June 18, 2018

Study Start

July 10, 2018

Primary Completion

June 30, 2019

Study Completion

December 30, 2019

Last Updated

November 10, 2021

Results First Posted

November 10, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations