Smart Community Rehabilitation

Musculoskeletal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05286606
• Other study ID #: UREC211525
• Status: Recruiting
• Start date: February 14, 2022
• Est. completion date: September 14, 2022

Study information

• Verified date: March 2022
• Source: Oxford Brookes University
• Contact: helen dawes, phd
• Phone: 01865483293
• Email: h.dawes[@]exeter.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: September 14, 2022
• Est. primary completion date: July 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

-

Related Conditions & MeSH terms

• Musculoskeletal Diseases

Intervention

Behavioral:
• Exercise and Social Groups
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.

Locations

Country	Name	City	State
United Kingdom	Oxford Brookes	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
Oxford Brookes University	University of Exeter

Country where clinical trial is conducted

United Kingdom, 

Outcome

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