Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

18 augustus 2026 bijgewerkt door: Anabela G Silva, Aveiro University

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

34

Fase

  • Niet toepasbaar

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: Gebruikelijke zorg
Ander: 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.
Andere namen:
  • Fysiotherapie
  • Medicijnen
  • Psychology
  • other intervention
Experimenteel: InControl intervention
Ander: 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.
Andere namen:
  • Oefening
  • Digital intervention
  • Pijnwetenschappelijk onderwijs
  • Functional objective
  • In-person

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Rates
Tijdsspanne: From enrollment to the end of treatment at 8 weeks
inclusion, refusal, exclusion, dropout and retetion
From enrollment to the end of treatment at 8 weeks
System Usability Scale
Tijdsspanne: At the end of 8 weeks of intervention
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
Tijdsspanne: At the end of 8 weeks of intervention
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
Tijdsspanne: At the end of 8 weeks of intervention
Semi-structured interview to explore participants' perceptions about programme acceptability
At the end of 8 weeks of intervention

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Sex
Tijdsspanne: Baseline
Please indicate the appropriate option: male, female, prefer not to say, other (please specify)
Baseline
Age
Tijdsspanne: Baseline
number of years
Baseline
Marital status
Tijdsspanne: Baseline
Select your marital status: Single, Married, In a civil partnership, Divorced Widowed
Baseline
Level of education
Tijdsspanne: Baseline
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
Tijdsspanne: Baseline
Please select: Full-time employee, Part-time employee, Domestic worker, Unemployed, Retired, Temporarily unfit for work
Baseline
Weight
Tijdsspanne: Baseline
weight in kilograms
Baseline
Height
Tijdsspanne: Baseline
height, in metres
Baseline
Falls
Tijdsspanne: Baseline
number of falls in the last year
Baseline
Number of medicines
Tijdsspanne: Baseline
number of regular medicines
Baseline
Comorbidities
Tijdsspanne: Baseline
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
Tijdsspanne: At baseline and at the end of the 8-week intervention
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
Tijdsspanne: At baseline and at the end of the 8-week intervention
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
Tijdsspanne: At baseline and at the end of the 8-week intervention
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
Tijdsspanne: At baseline and at the end of the 8-week intervention
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
Tijdsspanne: At baseline and at the end of the 8-week intervention
Bodychart
At baseline and at the end of the 8-week intervention
PainDETECT Questionnaire
Tijdsspanne: At baseline and at the end of 8-week intervention
The score ranges from -1 to 38 points
At baseline and at the end of 8-week intervention
Hand grip strength
Tijdsspanne: At baseline and at the end of 8-week intervention
Kg
At baseline and at the end of 8-week intervention
Gait speed test
Tijdsspanne: At baseline and at the end of 8-week intervention
metres per second
At baseline and at the end of 8-week intervention
5-sit-to-stand test
Tijdsspanne: At baseline and at the end of 8-week intervention
time in seconds
At baseline and at the end of 8-week intervention
Rapid Assessment of Physical Activity
Tijdsspanne: At baseline and at the end of 8-week intervention
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
Tijdsspanne: At baseline and at the end of 8-week intervention
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
Tijdsspanne: At baseline and at the end of 8-week intervention
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
Tijdsspanne: At baseline and at the end of 8-week intervention
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
Tijdsspanne: At baseline and at the end of 8-week intervention
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
Tijdsspanne: At the end of 8-week intervention
Scores range from 1 to 7. Higher scores indicate a greater overall perception of improvement
At the end of 8-week intervention

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Aveiro University

Onderzoekers

  • Hoofdonderzoeker: Anabela G. Silva, PhD, University of Aveiro

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

1 december 2026

Studie voltooiing (Geschat)

1 december 2026

Studieregistratiedata

Eerst ingediend

28 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

18 augustus 2026

Eerst geplaatst (Werkelijk)

19 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

19 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

18 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Currently in submission

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren