Personalized Online Occupational Therapy Intervention for Adults With Scleroderma (NCT07661836) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Personalized Online Occupational Therapy Intervention for Adults With Scleroderma
Spain24 participantsStarted 2026-05-16
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility: intervention completion
Timeframe: From baseline to post-intervention, approximately 4 weeks.