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

NCT07774416 | Not Yet Recruiting

• 1 other identifier: Currently in submission
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Musculoskeletal Pain

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (25)

• Sex

  Baseline

• Age

  Baseline

• Marital status

  Baseline

• Level of education

  Baseline

• Employment status

  Baseline

Study Arms (2)

Usual care

OTHER

Other: Usual Care

InControl intervention

EXPERIMENTAL

Other: InControl intervention

Interventions

InControl intervention OTHER

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.

Also known as: Exercise, Pain science education, Functional objective, Digital intervention, In-person

InControl intervention

Usual Care OTHER

Usual care is defined as the treatment that the participant would normally receive such as medication, physical therapy, or any other form of treatment.

Also known as: Medications, Physiotherapy, Physical Therapy, Psychology, other intervention

Usual care

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aveiro University: lead

MeSH Terms

Interventions

Exercise; Dosage Forms; Physical Therapy Modalities; Psychology

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques; Therapeutics; Rehabilitation; Behavioral Sciences; Behavioral Disciplines and Activities

Study Officials

• Anabela G. Silva, PhD

  University of Aveiro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Coordinating Professor/Principal Researcher

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 19, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share