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

Primary Purpose

Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
A Massive Open Online Course
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Low Back Pain focused on measuring Low back pain, Older adults, Work

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Lund UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Feasibility / A massive open course

Arm Description

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. 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.

Outcomes

Primary Outcome Measures

Retention rates
Of the people who are recruited into the study how many MOOC units do they complete
Recruitment of participants
Percentage of people who participate in the intervention by signing up directly to the website versus the percentage who are recruited via the research team
User satisfaction with the MOOC
Qualitative Semi-structured interviews/focus groups
Usability of the MOOC
System usability Scale(SUS), is a simple, ten-item scale giving a global view of subjective assessments of usability. The selected statements in the SUS are measured on a five point Likert scale and cover a variety of aspects of system usability, such as the need for support, training, and complexity, and thus have a high level of validity for measuring usability of a system. The scale yield a score between 0-100 were high values represent high usability.
Change in Participant's health-related quality of life
EQ-5D
Change in Functional disability
Functional disability will be measured by the Oswestry Disability Questionnaire. The ODQ consists of 10 sections, each with six levels (with a maximum score in each section of five points) that assess an individual's limitations in various activities of daily living. The sum of all 10 sections is divided by the total possible score and the result multiplied by 100 to generate a percentage score. Values range from 0 (best health state) to 100 (worst health state).
Patient ability to cope with with illness and life after using the MOOC
An adapted version of the Patient enablement Instrument (PEI), a six-item questionnaire designed to measure the patient's ability to understand and cope with illness and life following a consultation with a general practitioner will be used. Given this an adapted version of the PEI will be used, where the words 'after this appointment' and 'as a result of your visit to the doctor today' will be replaced by 'after using the Serious game (MOOC)' and 'as a result of using the Serious game(MOOC)

Secondary Outcome Measures

Full Information

First Posted
November 4, 2020
Last Updated
April 11, 2022
Sponsor
Lund University
Collaborators
University of Ulster, Kaunas University of Technology, Istituto Nazionale di Ricovero e Cura per Anziani
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1. Study Identification

Unique Protocol Identification Number
NCT04673773
Brief Title
MY RELIEF- Evidence Based Information to Support People Aged 55+ Years Living and Working With Persistent Low-back Pain.
Acronym
MY-RELIEF
Official Title
MY RELIEF- Evidence Based Information to Support People Aged 55+ Years Living and Working With Persistent Low-back Pain: Using a Digital Platform
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 27, 2021 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
January 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lund University
Collaborators
University of Ulster, Kaunas University of Technology, Istituto Nazionale di Ricovero e Cura per Anziani

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low back pain, Older adults, Work

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Feasibility / A massive open course
Arm Type
Experimental
Arm Description
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. 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.
Intervention Type
Behavioral
Intervention Name(s)
A Massive Open Online Course
Intervention Description
Same as intervention
Primary Outcome Measure Information:
Title
Retention rates
Description
Of the people who are recruited into the study how many MOOC units do they complete
Time Frame
4 weeks after baseline
Title
Recruitment of participants
Description
Percentage of people who participate in the intervention by signing up directly to the website versus the percentage who are recruited via the research team
Time Frame
4 weeks after baseline
Title
User satisfaction with the MOOC
Description
Qualitative Semi-structured interviews/focus groups
Time Frame
4 weeks after baseline
Title
Usability of the MOOC
Description
System usability Scale(SUS), is a simple, ten-item scale giving a global view of subjective assessments of usability. The selected statements in the SUS are measured on a five point Likert scale and cover a variety of aspects of system usability, such as the need for support, training, and complexity, and thus have a high level of validity for measuring usability of a system. The scale yield a score between 0-100 were high values represent high usability.
Time Frame
4 weeks after baseline
Title
Change in Participant's health-related quality of life
Description
EQ-5D
Time Frame
At baseline and 4 weeks later
Title
Change in Functional disability
Description
Functional disability will be measured by the Oswestry Disability Questionnaire. The ODQ consists of 10 sections, each with six levels (with a maximum score in each section of five points) that assess an individual's limitations in various activities of daily living. The sum of all 10 sections is divided by the total possible score and the result multiplied by 100 to generate a percentage score. Values range from 0 (best health state) to 100 (worst health state).
Time Frame
At baseline and 4 weeks later
Title
Patient ability to cope with with illness and life after using the MOOC
Description
An adapted version of the Patient enablement Instrument (PEI), a six-item questionnaire designed to measure the patient's ability to understand and cope with illness and life following a consultation with a general practitioner will be used. Given this an adapted version of the PEI will be used, where the words 'after this appointment' and 'as a result of your visit to the doctor today' will be replaced by 'after using the Serious game (MOOC)' and 'as a result of using the Serious game(MOOC)
Time Frame
4 weeks after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Understand Lithuanian (Lithuanian study), English (N Irish study), Italian (Italian study), Swedish (Sweden) and Portuguese (Portugal). Participant is willing and able to give informed consent for participation in the study via the study website. 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. Aged over 55 years In employment. Exclusion Criteria The participant may not enter the study if ANY of the following apply: People with unexplained symptoms People who have not seen a health care professional and received a diagnosis of persistent low back pain People who have been given a diagnosis of specific low back pain People with evidence of serious underlying pathology, such as a current diagnosis of cancer Anyone who has not used or have no interest in using a computer, laptop, tablet or mobile phone.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eva Ekvall-Hansson, PhD
Phone
+46 46 222 19 86
Email
eva.ekvall-hansson@med.lu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline Larsson, PhD
Phone
+46 46 222 19 86
Email
caroline.larsson@med.lu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Ekvall-Hansson, PhD
Organizational Affiliation
Lund University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lund University
City
Lund
ZIP/Postal Code
SE 221 00
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva E Ekvall Hansson, Professor
Phone
+46462221986
Email
eva.ekvall-hansson@med.lu.se
First Name & Middle Initial & Last Name & Degree
Caroline Larsson, PhD
Phone
+46462220000
Email
caroline.larsson@med.lu.se

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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