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 actualizado 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
34
Fase
- No aplica
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: Cuidado usual
|
Usual care is defined as the treatment that the participant would normally receive such as medication, physical therapy, or any other form of treatment.
Otros nombres:
|
|
Experimental: 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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Rates
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Sex
Periodo de tiempo: Baseline
|
Please indicate the appropriate option: male, female, prefer not to say, other (please specify)
|
Baseline
|
|
Age
Periodo de tiempo: Baseline
|
number of years
|
Baseline
|
|
Marital status
Periodo de tiempo: Baseline
|
Select your marital status: Single, Married, In a civil partnership, Divorced Widowed
|
Baseline
|
|
Level of education
Periodo de tiempo: 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
Periodo de tiempo: Baseline
|
Please select: Full-time employee, Part-time employee, Domestic worker, Unemployed, Retired, Temporarily unfit for work
|
Baseline
|
|
Weight
Periodo de tiempo: Baseline
|
weight in kilograms
|
Baseline
|
|
Height
Periodo de tiempo: Baseline
|
height, in metres
|
Baseline
|
|
Falls
Periodo de tiempo: Baseline
|
number of falls in the last year
|
Baseline
|
|
Number of medicines
Periodo de tiempo: Baseline
|
number of regular medicines
|
Baseline
|
|
Comorbidities
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: At baseline and at the end of 8-week intervention
|
Kg
|
At baseline and at the end of 8-week intervention
|
|
Gait speed test
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Anabela G. Silva, PhD, University of Aveiro
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
1 de diciembre de 2026
Finalización del estudio (Estimado)
1 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
28 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
18 de agosto de 2026
Publicado por primera vez (Actual)
19 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
19 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
18 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Actividad motora
- Movimiento
- Fenómenos fisiológicos musculoesqueléticos
- Fenómenos fisiológicos musculoesqueléticos y neuronales
- Preparaciones farmacéuticas
- Técnicas de investigación
- Terapéutica
- Tecnología, farmacéutica
- Disciplinas y actividades de comportamiento
- Rehabilitación
- Ciencias del comportamiento
- Ejercicio
- Formas de dosificación
- Modalidades de fisioterapia
- Psicología
Otros números de identificación del estudio
- Currently in submission
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .