MY RELIEF- Evidence Based Information to Support People Aged 55+ Years Living and Working With Persistent Low-back Pain. (MY-RELIEF)

Lund University

Status: Unknown

Conditions: Low Back Pain

Treatments: Behavioral: A Massive Open Online Course

Study type: Interventional

Funder types: Other

Identifiers

NCT04673773

018-1-SE01-KA204-039144

Details and patient eligibility

About

Low back pain is the main cause of activity limitation and work absence across the world, leading to a high social and economic burden for individuals, families, the labour market and society. This is particularly true for older adults of working age, employed in sedentary or arduous/strenuous jobs, whose work conditions may influence negatively this health problem and lead to severe persistent low back pain. Pain management is one of the most neglected aspects of healthcare and people suffering from persistent low back pain are often left without specific information, guidance and care from healthcare systems.

The MY-RELEF study is a multinational, multicenter, prospective uncontrolled, pre-post intervention feasibility study targeting people over the age of 55 years with persistent low back pain in Northern Lithuania, Ireland, Italy, Sweden and Portugal. Eligible participants will be offered the opportunity to use the MY RELIEF educational platform as part of their care and will undergo evaluations at baseline (enrollment) and at two-weeks and one-month follow-ups.

Full description

A Massive Open Online Course (MOOC) called MY RELIEF, have been developed. MY-RELIEF is built on best practices in e-learning, e-health and multimedia-based learning. The training package will be available on mobile devices such as a mobile phone or a tablet. The training is designed in short modules (10-12 minutes per module), possible to complete during a break in work. The MOOC will include short videos with older workers (aged 55+ years) with low back pain and professional experts, as well as knowledge tests and short factual texts. In addition, the target audience will have access to a serious game on their mobile phone that will track their health, and provide feedback on their potentially changing health status, and their engagement with the MOOC units.

The aim for this study is to determinate usability, acceptability and feasibility of a digital education program (MY-RELIEF) delivered via a MOOC for people aged 55+ years with persistent low back pain who are in sedentary or physically demanding jobs, and need advice on ergonomics, self-management of pain and healthy behavioral strategies.

The usability of the intervention will be measured with an industry standard tool to understand peoples ease of interaction with the MOOC and acceptability of the content and format of the MOOC will be measured via qualitative feedback from users.

Feasibility will be informed by the data on likely recruitment and follow up rates in each country for a main trial, floor and ceiling effects and completion rates on outcome measures, and likely within group effect sizes in response to the MOOC.

MY-RELIEF will help to improve and expand the range of high quality learning opportunities tailored to the needs of people over the age of 55 years.

Enrollment: 100 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

1. Understand Lithuanian (Lithuanian study), English (N Irish study), Italian (Italian study), Swedish (Sweden) and Portuguese (Portugal).
2. Participant is willing and able to give informed consent for participation in the study via the study website.
3. Persistent low back pain; defined as pain between scapulae and gluteal region, with or without radiation towards one or both legs, present for at least three months.
4. Aged over 55 years
5. In employment.

Exclusion Criteria

The participant may not enter the study if ANY of the following apply:

1. People with unexplained symptoms
2. People who have not seen a health care professional and received a diagnosis of persistent low back pain
3. People who have been given a diagnosis of specific low back pain
4. People with evidence of serious underlying pathology, such as a current diagnosis of cancer
5. Anyone who has not used or have no interest in using a computer, laptop, tablet or mobile phone.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Feasibility / A massive open course

Experimental group

Description:

1. The online MOOC contains eight units which cover the following topics (Understanding low back pain (LBP), Physical activity and exercise in relation to LBP, Psychological factors, Sleep / nutrition, Management of LBP at the workplace, Communication with health care, Other issues related to LBP). Each unit will include short factual texts, short videos (2-5mins) with older workers (aged 55+ years) with low back pain and professional experts, as well as knowledge tests. The complete MOOC will take 2-3 hours to complete. It would be possible to complete the MOOC at one time however users will be recommended to complete two units per week over a month period. 2. The mobile game is designed to encourage participation with the MOOC by providing feedback on engagement with the MOOC, presentation of quizzes to test knowledge gained on the MOOC, as well as feedback on clinical markers of their condition e.g. Mood, pain, physical activity levels.

Treatment:

Behavioral: A Massive Open Online Course