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Personalized Online Occupational Therapy Intervention for Adults With Scleroderma
Sponsor: Universidad de Zaragoza
Summary
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.
Official title: Pilot Exploratory Parallel-Group Randomized Controlled Trial to Evaluate a Personalized Online Occupational Therapy Intervention Versus Usual Care in Adults With Scleroderma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2026-05-16
Completion Date
2026-08
Last Updated
2026-06-22
Healthy Volunteers
No
Interventions
Personalized Online Occupational Therapy Intervention
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.
Usual Care
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.
Locations (1)
Universidad de Zaragoza
Zaragoza, Zaragoza / Aragón, Spain