No phaseCompleted
Personalized Online Occupational Therapy Intervention for Adults With Scleroderma
Pilot Exploratory Parallel-Group Randomized Controlled Trial to Evaluate a Personalized Online Occupational Therapy Intervention Versus Usual Care in Adults With Scleroderma
- Sponsor
- Universidad de Zaragoza (Academic or other)
- Enrolment
- 24 enrolled
- Conditions
- Scleroderma; Scleroderma (Limited and Diffuse); Systemic Sclerosis (SSc)
- Interventions
- Personalized Online Occupational Therapy Intervention; Usual Care
- Ages
- adults, older adults
- Registry
- NCT07661836
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Feasibility: intervention completion
History
Last registry update
Primary completion
Registered
Started