Feasibility, Acceptability And Usability Of The InControl Web Platform - A Rando Mized Parallel-Group Pilot Study of Mixed-methods

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-85
SponsorAveiro University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • InControl intervention

    Other intervention

    The 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 intervention

    Usual 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

34 Participants
are divided into 2 treatment groups
Group A: Usual careOther 1 intervention
Group B: InControl interventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Rates

inclusion, refusal, exclusion, dropout and retetion

Time frame
From enrollment to the end of treatment at 8 weeks
2

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.

Time frame
At the end of 8 weeks of intervention
3

Estructured questionnaire to assess aceptability

Estructured questionnaire Ten items, with scores ranging from 1 - totally disagree to 5 - totally agree

Time frame
At the end of 8 weeks of intervention
4

Semi-structured interview

Semi-structured interview to explore participants' perceptions about programme acceptability

Time frame
At the end of 8 weeks of intervention

Secondary outcomes

1

Sex

Please indicate the appropriate option: male, female, prefer not to say, other (please specify)

Time frame
Baseline
2

Age

number of years

Time frame
Baseline
3

Marital status

Select your marital status: Single, Married, In a civil partnership, Divorced Widowed

Time frame
Baseline
4

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)

Time frame
Baseline

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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