About this trial
This is a randomized, parallel-group pilot study that employs mixed methods (qualitative and quantitative approaches). The purpose of this study is to assess the feasibility, usability, and acceptability of an intervention with a digital component on the InControl web platform. The intervention is based on education in pain science and exercise, with the goal of managing chronic musculoskeletal pain in older adults. The intervention will be delivered through a combination of digital and in-person components and it will be compared to the usual intervention.
It will also inform the design of a randomized controlled trial to evaluate the cost-effectiveness of InControl.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
be 60 years or older;
have chronic musculoskeletal pain, defined as pain that persists for more than three months and is felt in the muscles, bones, joints, or tendons at least once a week;
know how to use a computer and/or a tablet; iv) have a score of 3 or higher on the Numerical Pain Scale for average pain intensity over the past week;
show no cognitive impairment, as determined by the Montreal Cognitive Assessment (MoCA) (validated and with normative data for the Portuguese population) and be available to participate in the study. The MoCA cutoff scores for the absence of cognitive impairment to be considered are adjusted for the participants' age and educational level [primary school (1-4 years), middle school (5-9 years), high school (10-12 years), and college (>12 years)], with 1.5 standard deviations: i) Ages 60-69: elementary school - 17 points, middle school - 21 points, high school and college - 22 points; ii) Ages 70-79: elementary school - 15 points, middle school - 18 points, high school - 20 points, and college - 22 points; iii) Over 80 years old: elementary school - 12 points, middle school - 22 points, high school - 17 points, and college - 19 points.
Disqualifiers
inability to read;
pain associated with serious conditions (e.g., tumors, fractures);
any acute, unstable, or decompensated medical conditions that prevent safe physical exercise. Examples include cardiovascular diseases (recent acute myocardial infarction, unstable angina, uncontrolled cardiac arrhythmias, severe symptomatic aortic stenosis, symptomatic or unstable heart failure, acute myocarditis or pericarditis, acute aortic dissection, active endocarditis, uncontrolled hypertension), respiratory conditions (acute pulmonary embolism, pulmonary infarction, chronic obstructive pulmonary disease, uncontrolled asthma, or recent respiratory exacerbations), metabolic conditions (uncontrolled diabetes mellitus), neurological conditions (stroke, traumatic brain injury, Parkinson's disease), or acute systemic infection.
In addition, participants will be screened according to the American College of Sports Medicine's Preparticipation Health Screening algorithm
Trial design
Parallel
Treatments tested in this trial
InControl intervention
Other interventionThe InControl intervention lasts 8 weeks and combines educational content on pain science and exercise on a digital platform. InControl is the result of a co-creation process between healthcare professionals and older adults with lived experience of chronic musculoskeletal pain.
Usual Care
Other interventionUsual care is defined as the treatment that the participant would normally receive such as medication, physical therapy, or any other form of treatment.
Treatment groups
Trial outcomes
Primary outcomes
Rates
inclusion, refusal, exclusion, dropout and retetion
System Usability Scale
Usability evatuated wiht the portuguese version of SUS The score ranges from 0 to 100. Higher scores are interpreted as indicating better usability.
Estructured questionnaire to assess aceptability
Estructured questionnaire Ten items, with scores ranging from 1 - totally disagree to 5 - totally agree
Semi-structured interview
Semi-structured interview to explore participants' perceptions about programme acceptability
Secondary outcomes
Sex
Please indicate the appropriate option: male, female, prefer not to say, other (please specify)
Age
number of years
Marital status
Select your marital status: Single, Married, In a civil partnership, Divorced Widowed
Level of education
Please select your level of education: Can read and write; 4th year of schooling; 6th year of schooling; 9th year of schooling; 12th year of schooling; Bachelor's degree; Other (please specify)
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: