Smart Community Rehabilitation

March 9, 2022 updated by: Helen Dawes, Oxford Brookes University

Transforming Older Adult Disability Through Virtual, Peer-Led Community Rehabilitation: Led By MSK Charities

Musculoskeletal (MSK) conditions affect 18.8 million people in the UK , accounting for 30% of all GP appointments with combined cost to the NHS of £5bn per year.. It is a highly prevalent and growing umbrella of pain, mobility, function, and inflammatory disorders that account for 40% of all sick leave. Older adults experience almost 2/3rd of MSK prevalence and BAME groups experience high prevalence of certain MSKDs with access inequalities in MSK care and poorer outcomes (Versus Arthritis, 2019). Suffering from a chronic MSK condition is associated with decreased functional capacity, reduction in physical activity and mobility which ultimately results in high costs to health services. In the current climate, the effect of social isolation and redirecting of health care services may prove to expedite the effect of an MSK condition on functional capacity.

There is a large body of evidence for the use of physical activity demonstrates the effectiveness of exercise to treat, manage and prevent MSK conditions . Exercise is one of the primary tools utilised by Physiotherapists throughout the nation and the 'State of Musculoskeletal Health 2019' published by Versus Arthritis cites physical inactivity as a core contributor in growing MSK prevalence and the benefits of exercise for MSK conditions . Access to Physiotherapy services, either due to waiting times, high cost of private care or the non-proximity or remote access to services like Escape Pain are barriers for people living with MSK conditions. Additionally, the primary barrier to anyone living with an MSK condition to being active is pain . As a result, the use of mobile applications to deliver exercise programmes has increased, however, there is a lack of provision for the population of people with MSK problems. Research evidence demonstrates that exercise is highly effective in supporting people living with a joint or pain condition to reduce pain, improve mobility and improve the overall quality of life. However, in the current effect of Covid-19, many people with MSK problems no longer have access to physiotherapy as well as social isolation limiting the opportunities to engage in meaningful physical activity. Trusted by clinicians and patients, MSK charities are the foremost support service to deliver care closer to home, aligning with the NHS strategy.

This project will co-design a solution that is accessible and inclusive by combining cutting-edge technology and MSK charities' networks and expertise, to deliver virtual community MSK rehab, providing an innovative and cost-effective solution to the significant UK and global health challenge. Already overburdened, NHS MSK services are even more pressured due to COVID-19. The project will develop and validate a commercially scalable rehab solution to reduce this pressure. The solution empowers MSK charities to deliver rehab services to beneficiaries through existing, leading-edge AI-powered physiotherapy software. This not only plugs the gap left by long Physiotherapy waiting lists but serves to improve upon existing services by increasing reach and engagement through its community and peer-support aspects. Insight from MSK charities has demonstrated the need for emotional, peer-led and practical rehab solutions that encourage and support patients. The project will be game-changing in driving improved health outcomes for patients and reducing NHS burden and costs.

Study Overview

Status

Recruiting

Detailed Description

1.2.1 Background: Musculoskeletal (MSK) conditions affect 18.8 million people in the UK , accounting for 30% of all GP appointments with combined cost to the NHS of £5bn per year. It is a highly prevalent and growing umbrella of pain, mobility, function, and inflammatory disorders that account for 40% of all sick leave. Older adults experience almost 2/3rd of MSK prevalence and BAME groups experience high prevalence of certain MSKDs with access inequalities in MSK care and poorer outcomes (Versus Arthritis, 2019). Suffering from a chronic MSK condition is associated with decreased functional capacity, reduction in physical activity and mobility which ultimately results in high costs to health services. In the current climate, the effect of social isolation and redirecting of health care services may prove to expedite the effect of an MSK condition on functional capacity.

There is a large body of evidence for the use of physical activity demonstrates the effectiveness of exercise to treat, manage and prevent MSK conditions. Exercise is one of the primary tools utilised by Physiotherapists throughout the nation and the 'State of Musculoskeletal Health 2019' published by Versus Arthritis cites physical inactivity as a core contributor in growing MSK prevalence and the benefits of exercise for MSK conditions. Access to Physiotherapy services, either due to waiting times , high cost of private care or the non-proximity or remote access to services like Escape Pain are barriers for people living with MSK conditions. Additionally, the primary barrier to anyone living with an MSK condition to being active is pain. As a result, the use of mobile applications to deliver exercise programmes has increased, however, there is a lack of provision for the population of people with MSK problems. Research evidence demonstrates that exercise is highly effective in supporting people living with a joint or pain condition to reduce pain, improve mobility and improve the overall quality of life. However, in the current effect of Covid-19, many people with MSK problems no longer have access to physiotherapy as well as social isolation limiting the opportunities to engage in meaningful physical activity. Trusted by clinicians and patients, MSK charities are the foremost support service to deliver care closer to home, aligning with the NHS strategy.

This project will co-design a solution that is accessible and inclusive by combining cutting-edge technology and MSK charities' networks and expertise, to deliver virtual community MSK rehab, providing an innovative and cost-effective solution to the significant UK and global health challenge. Already overburdened, NHS MSK services are even more pressured due to COVID-19. The project will develop and validate a commercially scalable rehab solution to reduce this pressure. The solution empowers MSK charities to deliver rehab services to beneficiaries through existing, leading-edge AI-powered physiotherapy software. This not only plugs the gap left by long Physiotherapy waiting lists but serves to improve upon existing services by increasing reach and engagement through its community and peer-support aspects. Insight from MSK charities has demonstrated the need for emotional, peer-led and practical rehab solutions that encourage and support patients. The project will be game-changing in driving improved health outcomes for patients and reducing NHS burden and costs.

1.2.2 Aim: This research project aims to complete product testing, co-production, and research to achieve regulatory approval for public rollout and commercialisation to create a publicly accessible product which will address clinical rehab needs for MSKDs and reduce health inequality. The project will determine the usability, acceptability, and feasibility for use of the developed App.

1.2.3 Objectives: There are two objectives in this study. First one is the usability of the app and second one is the app feasibility

Usability: To discover the barriers and facilitators and potential of using and adopting virtual group digital technology in the management of MSK condition.

Feasibility: to determine the safety, usability and potential benefit of the app

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Users with MSK using the exercise program: In Phase II work package 1: recruitment of the first group of people will be recruited via charities who are collaborating and participating in the Good Boost exercise program, all will participate in a three-month pilot of the beta-app and up to n = 40 of these will be invited to pre and post beta-testing focus groups.

Facilitators facilitating the program: The facilitators for the virtual groups will be recruited equally by the charities and will work for GoodBoost to facilitate the study for the app users.

Health Care Professionals (HCP): The focus group will also be recruited at this phase . Ideally initially recruited facilitators and HCPs will complete all phases of the research but additional will be recruited as needed for example in phase III more facilitators possibly will be recruited if user sample size is large. They can be study First testers as a volunteer and will take part in a focus group with two sessions.

Description

Inclusion Criteria:

  • Inclusion criteria app user

Aged over 18

Living with an MSK condition

Is happy to take part in exercise at home

Has not been advised by a health care professional to stop/avoid physical activity and complete the Canadian Physical Activity Questionnaire PARQ

Has an apple (iOS) or Android phone to download the app.

Is happy to take part in the pilot for the duration of the 3-month pilot (if they are signing up for the first quarter (Oct-Jan) or second quarter (Jan-Apr). Over this time that participants will average at least one 30-minute session every two weeks

Is happy to provide feedback on their experience to improve the digital service (through up to 2x virtual focus groups and 2 x online questionnaires)

Is happy to volunteer and consent for their anonymised data to be included in the project research evaluation

2.2.2 Virtual group facilitators (Facilitators)

Sample size (Recruitment phase I; up to n = 10, Recruitment phase III up to 20 depending on requirement based on user recruitment).

Inclusion criteria

These are recruited by the charities, internally and thus inclusion is based on the specific charities

undergone the facilitators training course.

2.2. 3 Focus group

Sample size (Recruitment phase I; up to n = 10. Charities have their own clinical experts and recruitment will from their initially (no advert needed. This group are not study participants but could take part as first app testers to feedback and help in the design) 2.2.2 Virtual group facilitators (Facilitators)

Sample size (Recruitment phase I; up to n = 10, Recruitment phase III up to 20 depending on requirement based on user recruitment).

Inclusion criteria

These are recruited by the charities, internally and thus inclusion is based on the specific charities

undergone the facilitators training course.

2.2. 3 Experts (HCP)

Healthcare professional involved in treatment of MSK condition

Exclusion Criteria:

not meeting the inclusion criteria for each group Under 18 years old Not being familiar with technology

-

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Focus groups
Health Care Professionals (HCP), facilitators, participants in the exercise program will be invited to participate in focus groups to comment on usability/acceptability.
App users
Users of the exercise program with musculoskeletal conditions have been referred to the exercise program via the charities, all will be participating in a three-month program using the beta version of the app. They will be invited to participate in the program evaluation

Participants in the exercise program, which will include a 2-3 time a week 30-45-minute group exercise programme over a 3-month period, 2 x three months. The intervention consists of a 30-45-minute exercise programme. The exercise programme is created by the Good Boost AI based on pre-registration questions or premade sessions, these are either generic sessions with options of strength, aerobic flexibility and balance/coordination exercise with intensity adjusted according to the user's feedback.

In this program the intervention content is standardised through the Good Boost exercise program. The standard program involves all users to be registered to a single group and to log on to the group, through, zoom, and the facilitator welcomes them. The group then performs the exercise programme they would like to do guided through the app, and afterwards they all meet on a group chat and get peer support.

Facilitators
Facilitators of the exercise program: The facilitators for the virtual groups have been recruited equally by the charities and are working for GoodBoost to facilitate the exercise program for the app users. They will be invited to participate in the program evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
We are performing a program evaluation of the Good Boost exercise program. The primary outcome is measuring the usability of the APP over the program.
Time Frame: 6 months
We are determining usability as measured by the number of sessions attended.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health related Quality of life (EQ 5D)
Time Frame: 6 months
Eq5d
6 months
MSK condition musculoskeletal health Questionnaire (MSK-HQ)
Time Frame: 6 month
MSK condition musculoskeletal health Questionnaire (MSK-HQ)
6 month
Physical activity International Physical activity questionnaire.(IPAQ
Time Frame: 6 month
Physical activity International Physical activity questionnaire.(IPAQ
6 month
Functional capacity 2 sit to stand (30 sec)
Time Frame: 6 month
measured using an IMU sit to stand on the spot
6 month
Functional capacity 3 Timed up and go (time) sec )
Time Frame: 6 month
measured over a 3 meter course using an IMU
6 month
Accessiblity
Time Frame: 6 month
app usage using interviews and views and opininions
6 month
Completion of outcome measures
Time Frame: 6 months
percentage of completion of the Health related Quality of life (EQ 5D), Physical activity International Physical activity questionnaire.(IPAQ) and MSK condition musculoskeletal health Questionnaire (MSK-HQ).
6 months
recrtuitment rate
Time Frame: 6 months
recruitment rate of the number of people expressing an interest in using the app and registering on the study.
6 months
Retention to the research measures
Time Frame: 6 months
retention as measured by completion outcome measures at follow up
6 months

Collaborators and Investigators

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

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)

February 14, 2022

Primary Completion (Anticipated)

July 14, 2022

Study Completion (Anticipated)

September 14, 2022

Study Registration Dates

First Submitted

February 7, 2022

First Submitted That Met QC Criteria

March 9, 2022

First Posted (Actual)

March 18, 2022

Study Record Updates

Last Update Posted (Actual)

March 18, 2022

Last Update Submitted That Met QC Criteria

March 9, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UREC211525

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.

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