Personalized Online Occupational Therapy Intervention for Adults With Scleroderma
16 de junio de 2026 actualizado por: Sandra Martina Espín Tello, Universidad de Zaragoza
Pilot Exploratory Parallel-Group Randomized Controlled Trial to Evaluate a Personalized Online Occupational Therapy Intervention Versus Usual Care in Adults With Scleroderma
This pilot exploratory randomized controlled trial will evaluate the feasibility, acceptability, and safety of a personalized online occupational therapy intervention for adults with scleroderma in Spain.
Participants will be individually randomized in a 1:1 ratio to either an online occupational therapy intervention added to usual care or usual care alone.
The intervention consists of eight individual online occupational therapy sessions delivered over four weeks, with two sessions per week, plus individualized materials.
The control group will continue with usual care during the intervention and follow-up period.
Outcomes will be assessed at baseline, post-intervention, and four weeks after the end of the intervention.
The primary outcome is feasibility, defined as the proportion of participants in the intervention group who complete at least six of the eight planned sessions.
Secondary and exploratory outcomes include acceptability, adherence, safety, technical feasibility, functioning, quality of life, occupational balance, hand function, and individual goal attainment.
Descripción general del estudio
Estado
Activo, no reclutando
Intervención / Tratamiento
Descripción detallada
Scleroderma is a chronic connective tissue disease that may be associated with skin and visceral fibrosis, pain, fatigue, stiffness, respiratory symptoms, gastrointestinal symptoms, vascular alterations, and functional limitations. From an occupational perspective, these manifestations may affect activities of daily living, self-care, work, leisure, social participation, quality of life, hand function, and occupational balance.
This study is based on a previous cohort of adults with scleroderma in Spain, in which information was collected on functioning, quality of life, occupational balance, hand function, symptoms, assistive products, and unmet needs. The present phase aims to implement and preliminarily evaluate a personalized, occupation-centered, online occupational therapy intervention.
The study is a pilot exploratory parallel-group randomized controlled trial with individual allocation in a 1:1 ratio. It is coordinated by the University of Zaragoza and delivered remotely. Participants take part from their home or community environment in Spain. The intervention group receives eight individual online occupational therapy sessions, approximately 50-60 minutes each, twice weekly over four weeks, through Google Meet and without recording. The intervention is individualized according to baseline assessment and the first session, including personalized occupational goals using SMART criteria and Goal Attainment Scaling. The control group continues with usual care and does not receive additional intervention from the research team during the intervention and follow-up period. After completing follow-up, the control group will receive access to general educational materials and will be offered an online educational group session.
The primary feasibility outcome is the proportion of intervention-group participants who complete at least six of the eight planned sessions at post-intervention assessment. The pre-specified feasibility threshold is at least 70%. Secondary outcomes include acceptability, adherence, safety, and technical feasibility. Exploratory clinical and occupational outcomes include WHODAS 2.0, WHOQOL-BREF, Occupational Balance Questionnaire, Cochin Hand Function Scale, and Goal Attainment Scaling in the intervention group.
Tipo de estudio
Intervencionista
Inscripción (Actual)
24
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Zaragoza / Aragón
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Zaragoza, Zaragoza / Aragón, España, 50009
- Universidad de Zaragoza
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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:
- Adults aged 18 years or older with scleroderma from the previous project cohort and meeting the general eligibility criteria of the initial study.
- Current residence in Spain.
- Sufficient Spanish language ability to provide informed consent, participate in the intervention, and complete study assessments.
- Ability to understand the study information and provide informed consent, with support if needed.
- Access to the internet and to a device compatible with Google Meet and Hefora.
- Availability to participate in eight online sessions of approximately 60 minutes, twice weekly over four weeks.
- Not currently participating in a specific occupational therapy program or another intervention that could substantially influence functioning, activities of daily living, quality of life, or occupational balance.
- Provision of informed consent and completion of the baseline assessment.
Exclusion Criteria:
- Clinical condition or severe comorbidity preventing safe participation.
- Current residence outside Spain.
- Inability to provide informed consent or complete the baseline assessment.
- Concurrent participation in a specific occupational therapy program or another intensive, potentially interfering rehabilitation or therapeutic education intervention.
- Withdrawal of interest before the effective start of the intervention or inability to participate during the planned study dates.
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: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Personalized Online Occupational Therapy Plus Usual Care
Participants allocated to the intervention group will receive eight individual online occupational therapy sessions over four weeks, with two sessions per week, delivered by videoconference and added to usual care.
Sessions will be individualized according to baseline assessment and participant goals and may include goal setting, hand preparation for occupation, self-care and pain management, energy conservation, daily planning, environmental adaptations, assistive product guidance, occupational balance, functional integration, and a maintenance plan.
Sessions will not be recorded.
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The intervention consists of eight individual online occupational therapy sessions delivered over four weeks, with two sessions per week, through videoconference and without recording.
Sessions are individualized according to baseline assessment, participant needs, and personalized occupational goals.
The intervention may include goal setting using SMART criteria and Goal Attainment Scaling, hand preparation for occupation, self-care and pain management strategies, energy conservation, daily planning, environmental adaptations, assistive product guidance, occupational balance strategies, functional integration, and a maintenance plan.
The intervention is delivered in addition to usual care.
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Comparador activo: Usual Care
Participants allocated to the control group will continue with their usual health and social care during the intervention and follow-up period.
They will not receive additional occupational therapy from the research team during this period.
Changes in usual care will be recorded at post-intervention and follow-up assessments.
After completing follow-up, participants in this arm will receive access to general educational materials and will be offered an online educational group session.
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Usual care refers to the ordinary health and social care that participants receive in their usual context.
It is not administered by the research team.
Participants allocated to this arm will not receive additional occupational therapy from the research team during the intervention and follow-up period.
Changes in usual care will be recorded at post-intervention and follow-up assessments.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Feasibility: intervention completion
Periodo de tiempo: From baseline to post-intervention, approximately 4 weeks.
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Percentage of participants allocated to the intervention group who complete at least 6 of the 8 planned online occupational therapy sessions.
The pre-specified feasibility threshold is 70% or higher.
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From baseline to post-intervention, approximately 4 weeks.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Acceptability: session satisfaction
Periodo de tiempo: After each intervention session during the 4-week intervention period.
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Participant satisfaction after each intervention session, assessed using Likert-type items scored from 1 to 5 and open-ended questions.
Items address perceived usefulness, integration into daily routine, comprehension, self-efficacy, perceived safety, and suggestions for improvement.
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After each intervention session during the 4-week intervention period.
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Acceptability: final intervention satisfaction questionnaire score
Periodo de tiempo: Post-intervention, approximately 4 weeks after baseline.
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Final satisfaction with the intervention will be assessed in the intervention group using a structured final intervention satisfaction questionnaire administered at post-intervention.
The questionnaire includes Likert-type items scored from 1 to 5. A mean satisfaction score will be calculated across the Likert-type items, with higher scores indicating greater intervention acceptability and satisfaction.Open-ended questions will also be used to collect qualitative feedback on acceptability, perceived usefulness, and suggestions for improvement; these qualitative responses will be summarized descriptively and will not be included in the numerical score.
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Post-intervention, approximately 4 weeks after baseline.
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Complementary adherence: Percentage of expected weekly diaries completed
Periodo de tiempo: Weekly during the 4-week intervention period.
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Complementary adherence will be assessed in the intervention group using the weekly participant diary.
The outcome will be reported as the percentage of expected weekly diaries completed by each participant during the 4-week intervention period.
Four weekly diaries are expected per participant.
The percentage ranges from 0% to 100%, with higher percentages indicating greater adherence to weekly diary completion.
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Weekly during the 4-week intervention period.
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Complementary adherence: Percentage of agreed home-based tasks completed
Periodo de tiempo: Weekly during the 4-week intervention period and post-intervention, approximately 4 weeks after baseline.
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Completion of agreed home-based tasks will be assessed in the intervention group using participant self-reports recorded in the weekly diary and adherence record.
Each week, task completion will be recorded as completed, partially completed, or not completed.
The outcome will be reported as the percentage of agreed home-based tasks completed during the intervention period.
The percentage ranges from 0% to 100%, with higher percentages indicating greater adherence to the agreed home-based tasks.
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Weekly during the 4-week intervention period and post-intervention, approximately 4 weeks after baseline.
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Complementary adherence: Percentage of intervention materials reviewed
Periodo de tiempo: Weekly during the 4-week intervention period and post-intervention, approximately 4 weeks after baseline.
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Review of intervention materials will be assessed in the intervention group using participant self-reports recorded in the weekly diary and adherence record.
Each week, participants will report whether they reviewed the materials shared with them.
The outcome will be reported as the percentage of intervention materials reviewed during the intervention period.
The percentage ranges from 0% to 100%, with higher percentages indicating greater adherence to reviewing the intervention materials.
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Weekly during the 4-week intervention period and post-intervention, approximately 4 weeks after baseline.
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Safety: adverse events
Periodo de tiempo: Continuously during the intervention period and at post-intervention and follow-up assessments, up to approximately 8 weeks after baseline.
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Number of adverse events and number of participants with at least one adverse event, classified by severity, relationship with the intervention, outcome, and whether the event led to interruption, adaptation, or discontinuation of a session.
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Continuously during the intervention period and at post-intervention and follow-up assessments, up to approximately 8 weeks after baseline.
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Technical feasibility
Periodo de tiempo: Continuously during the intervention period and assessment windows, up to approximately 8 weeks after baseline.
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Frequency, type, and impact of technical incidents affecting online intervention delivery, participant participation, or online data collection.
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Continuously during the intervention period and assessment windows, up to approximately 8 weeks after baseline.
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in functioning assessed by the Spanish version of the World Health Organization Disability Assessment Schedule 2.0
Periodo de tiempo: Baseline, post-intervention at approximately 4 weeks, and follow-up at approximately 8 weeks.
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Functioning will be assessed using the World Health Organization Disability Assessment Schedule 2.0.
Scores will be transformed to a 0 to 100 scale, where 0 indicates no disability and 100 indicates full disability.
Higher scores indicate worse functioning or greater disability.
Change from baseline to post-intervention and from baseline to follow-up will be described.
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Baseline, post-intervention at approximately 4 weeks, and follow-up at approximately 8 weeks.
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Change in quality of life assessed by the Spanish version of the World Health Organization Quality of Life-BREF
Periodo de tiempo: Baseline, post-intervention at approximately 4 weeks, and follow-up at approximately 8 weeks.
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Quality of life will be assessed using the World Health Organization Quality of Life-BREF.
The questionnaire provides four domain scores: physical health, psychological health, social relationships, and environment.
Domain scores will be transformed to a 0 to 100 scale.
Higher scores indicate a better quality of life.
Change from baseline to post-intervention and from baseline to follow-up will be described.
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Baseline, post-intervention at approximately 4 weeks, and follow-up at approximately 8 weeks.
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Change in occupational balance assessed by the Spanish version of the Occupational Balance Questionnaire
Periodo de tiempo: Baseline, post-intervention at approximately 4 weeks, and follow-up at approximately 8 weeks.
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Occupational balance will be assessed using the Spanish version of the Occupational Balance Questionnaire.
The questionnaire consists of 13 items, each scored from 0 to 5. The total score ranges from 0 to 65, with higher scores indicating greater occupational balance.
Change from baseline to post-intervention and from baseline to follow-up will be described.
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Baseline, post-intervention at approximately 4 weeks, and follow-up at approximately 8 weeks.
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Change in hand function assessed by the Spanish version of the Cochin Hand Function Scale
Periodo de tiempo: Baseline, post-intervention at approximately 4 weeks, and follow-up at approximately 8 weeks.
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Hand function will be assessed using the Cochin Hand Function Scale.
The scale includes 18 items assessing difficulty in performing hand-related daily activities.
The total score ranges from 0 to 90, with higher scores indicating worse hand function or greater hand-related disability.
Change from baseline to post-intervention and from baseline to follow-up will be described.
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Baseline, post-intervention at approximately 4 weeks, and follow-up at approximately 8 weeks.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Sandra M Espín Tello, PhD, Universidad de Zaragoza
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Garin O, Ayuso-Mateos JL, Almansa J, Nieto M, Chatterji S, Vilagut G, Alonso J, Cieza A, Svetskova O, Burger H, Racca V, Francescutti C, Vieta E, Kostanjsek N, Raggi A, Leonardi M, Ferrer M; MHADIE consortium. Validation of the "World Health Organization Disability Assessment Schedule, WHODAS-2" in patients with chronic diseases. Health Qual Life Outcomes. 2010 May 19;8:51. doi: 10.1186/1477-7525-8-51.
- Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310. doi: 10.1023/B:QURE.0000018486.91360.00.
- Lucas-Carrasco R. The WHO quality of life (WHOQOL) questionnaire: Spanish development and validation studies. Qual Life Res. 2012 Feb;21(1):161-5. doi: 10.1007/s11136-011-9926-3. Epub 2011 May 25.
- Peral-Gomez P, Lopez-Roig S, Pastor-Mira MA, Abad-Navarro E, Valera-Gran D, Hakansson C, Wagman P. Cultural Adaptation and Psychometric Properties of the Spanish Version of the Occupational Balance Questionnaire: An Instrument for Occupation-Based Research. Int J Environ Res Public Health. 2021 Jul 14;18(14):7506. doi: 10.3390/ijerph18147506.
- Chan AW, Boutron I, Hopewell S, Moher D, Schulz KF, Collins GS, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne DR, Farmer AJ, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson DJ, Vohra S, White IR, Hrobjartsson A. SPIRIT 2025 statement: updated guideline for protocols of randomised trials. BMJ. 2025 Apr 28;389:e081477. doi: 10.1136/bmj-2024-081477.
- Arreguin Reyes R, Lopez Lopez CO, Alvarez Hernandez E, Medrano Ramirez G, Montes Castillo Mde L, Vazquez-Mellado J. Evaluation of hand function in rheumatic disease. Validation and usefulness of the Spanish version AUSCAN, m-SACRAH and Cochin questionnaires. Reumatol Clin. 2012 Sep-Oct;8(5):250-4. doi: 10.1016/j.reuma.2012.03.005. Epub 2012 May 17.
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 (Actual)
16 de mayo de 2026
Finalización primaria (Estimado)
1 de julio de 2026
Finalización del estudio (Estimado)
1 de agosto de 2026
Fechas de registro del estudio
Enviado por primera vez
10 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
16 de junio de 2026
Publicado por primera vez (Actual)
22 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
16 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- C.I. PI26/254
- 216213 (Otro número de subvención/financiamiento: Asociación Española de Esclerodermia)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Individual participant data will not be publicly shared due to the small sample size, the low prevalence of systemic sclerosis, and the potential risk of re-identification from the combination of sociodemographic, clinical, and occupational variables.
Study findings will be disseminated only in aggregate form.
General intervention materials and statistical code may be shared after review to remove any potentially identifiable information, but no individual participant-level dataset will be deposited in a public repository.
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. .