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

Feasibility, Acceptability And Usability Of The InControl Web Platform - A Mixed-methods Pilot Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Musculoskeletal Pain
• Intervention / Treatment: Other: Usual Care; Other: InControl intervention

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Usual care	Other: Usual Care; Usual care is defined as the treatment that the participant would normally receive such as medication, physical therapy, or any other form of treatment.; Other Names: Physiotherapy; Physical Therapy; Medications; Psychology; other intervention
Experimental: InControl intervention	Other: InControl 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.; Other Names: Exercise; Digital intervention; Pain science education; Functional objective; In-person

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates	inclusion, refusal, exclusion, dropout and retetion	From enrollment to the end of treatment at 8 weeks
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.	At the end of 8 weeks of intervention
Estructured questionnaire to assess aceptability	Estructured questionnaire Ten items, with scores ranging from 1 - totally disagree to 5 - totally agree	At the end of 8 weeks of intervention
Semi-structured interview	Semi-structured interview to explore participants' perceptions about programme acceptability	At the end of 8 weeks of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sex	Please indicate the appropriate option: male, female, prefer not to say, other (please specify)	Baseline
Age	number of years	Baseline
Marital status	Select your marital status: Single, Married, In a civil partnership, Divorced Widowed	Baseline
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)	Baseline
Employment status	Please select: Full-time employee, Part-time employee, Domestic worker, Unemployed, Retired, Temporarily unfit for work	Baseline
Weight	weight in kilograms	Baseline
Height	height, in metres	Baseline
Falls	number of falls in the last year	Baseline
Number of medicines	number of regular medicines	Baseline
Comorbidities	Please select: No medical conditions, High blood pressure, Diabetes, Osteoarthritis (please specify the affected area), Cardiovascular conditions, Respiratory conditions, Neurological conditions, Cancer, Arthritis, Osteoporosis, Vision problems, Hearing problems, Other (please specify)	Baseline
EQ-5D-5L	The EQ-5D-5L score ranges from 1 to 5 for each domain	At baseline and at the end of the 8-week intervention
EQ-VAS	The score of EQ-VAS ranges from 0 to 100. Higher scores are interpreted as indicating a better perception of health quality	At baseline and at the end of the 8-week intervention
Montreal Cognitive Assessment	MoCA scores range from 0 to 30. Higher scores indicate better cognitive performance	At baseline and at the end of the 8-week intervention
Brief Pain Inventory	On the pain severity subscale, scores range from 0 to 40 points. On the pain-related interference subscale, scores range from 0 to 70 points. Higher scores indicate greater severity or pain-related interference, respectively	At baseline and at the end of the 8-week intervention
Location and number of painful sites	Bodychart	At baseline and at the end of the 8-week intervention
PainDETECT Questionnaire	The score ranges from -1 to 38 points	At baseline and at the end of 8-week intervention
Hand grip strength	Kg	At baseline and at the end of 8-week intervention
Gait speed test	metres per second	At baseline and at the end of 8-week intervention
5-sit-to-stand test	time in seconds	At baseline and at the end of 8-week intervention
Rapid Assessment of Physical Activity	Depending on physical activity, there are five levels of physical activity: sedentary - item 1, ii) slightly active - item 2, iii) regularly slightly active (light activity) - item 3, iv) regularly slightly active - items 4 and 5, and v) active - items 6 and 7	At baseline and at the end of 8-week intervention
Pain Catastrophizing Scale	The minimum score is 0 and the maximum is 52. Higher scores are associated with higher levels of catastrophic thinking	At baseline and at the end of 8-week intervention
Tampa Scale of Kinesiophobia	Scores range from 13 to 52 points. Higher scores are associated with greater fear of movement	At baseline and at the end of 8-week intervention
Geriatric Depression Scale	Scores range from 0 to 15. Higher scores indicate more depressive symptoms	At baseline and at the end of 8-week intervention
Strength, Assistance with walking, Rise from a chair, Climb stairs and Falls	SARC-F. Scores range from 0 to 10. Total scores of 4 or above are suggestive of sarcopenia	At baseline and at the end of 8-week intervention
Patient Global Impression of Change	Scores range from 1 to 7. Higher scores indicate a greater overall perception of improvement	At the end of 8-week intervention

Collaborators and Investigators

• Sponsor: Aveiro University
• Investigators: Principal Investigator: Anabela G. Silva, PhD, University of Aveiro

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 28, 2026
• First Submitted That Met QC Criteria: August 18, 2026
• First Posted (Actual): August 19, 2026

Study Record Updates

• Last Update Posted (Actual): August 19, 2026
• Last Update Submitted That Met QC Criteria: August 18, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Pharmaceutical Preparations; Investigative Techniques; Therapeutics; Technology, Pharmaceutical; Behavioral Disciplines and Activities; Rehabilitation; Behavioral Sciences; Exercise; Dosage Forms; Physical Therapy Modalities; Psychology
• Other Study ID Numbers: Currently in submission

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No