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

18 de agosto de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

34

Estágio

  • Não aplicável

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Outro
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Outro: Cuidados usuais
Outro: 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.
Outros nomes:
  • Fisioterapia
  • Medicamentos
  • Psychology
  • other intervention
Experimental: InControl intervention
Outro: 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.
Outros nomes:
  • Exercício
  • Digital intervention
  • Educação em ciências da dor
  • Functional objective
  • In-person

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Rates
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Sex
Prazo: Baseline
Please indicate the appropriate option: male, female, prefer not to say, other (please specify)
Baseline
Age
Prazo: Baseline
number of years
Baseline
Marital status
Prazo: Baseline
Select your marital status: Single, Married, In a civil partnership, Divorced Widowed
Baseline
Level of education
Prazo: 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
Prazo: Baseline
Please select: Full-time employee, Part-time employee, Domestic worker, Unemployed, Retired, Temporarily unfit for work
Baseline
Weight
Prazo: Baseline
weight in kilograms
Baseline
Height
Prazo: Baseline
height, in metres
Baseline
Falls
Prazo: Baseline
number of falls in the last year
Baseline
Number of medicines
Prazo: Baseline
number of regular medicines
Baseline
Comorbidities
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: At baseline and at the end of 8-week intervention
Kg
At baseline and at the end of 8-week intervention
Gait speed test
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Aveiro University

Investigadores

  • Investigador principal: Anabela G. Silva, PhD, University of Aveiro

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de setembro de 2026

Conclusão Primária (Estimado)

1 de dezembro de 2026

Conclusão do estudo (Estimado)

1 de dezembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

28 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

18 de agosto de 2026

Primeira postagem (Real)

19 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

19 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

18 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • Currently in submission

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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