An interventional study of Personalized Online Occupational Therapy Intervention and Usual Care in Scleroderma, Scleroderma (Limited and Diffuse) and Systemic Sclerosis (SSc), sponsored by Universidad de Zaragoza. Active, not recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by Universidad de Zaragoza · Not applicable, Interventional, and Supportive care
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.
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.
528 studies on the registry are indexed under Scleroderma, Diffuse; 114 are open to participants now.
This study's enrollment of 24 is below the median of 33 across 366 interventional studies indexed under Scleroderma, Diffuse.
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Exclusion Criteria:
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.
Behavioral: Personalized Online Occupational Therapy Intervention
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.
Other: Usual Care
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 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.
Feasibility: intervention completion
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.
Time frame: From baseline to post-intervention, approximately 4 weeks.
Acceptability: session satisfaction
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.
Time frame: After each intervention session during the 4-week intervention period.
Acceptability: final intervention satisfaction questionnaire score
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.
Time frame: Post-intervention, approximately 4 weeks after baseline.
Complementary adherence: Percentage of expected weekly diaries completed
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.
Time frame: Weekly during the 4-week intervention period.
Complementary adherence: Percentage of agreed home-based tasks completed
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.
Time frame: Weekly during the 4-week intervention period and post-intervention, approximately 4 weeks after baseline.
Complementary adherence: Percentage of intervention materials reviewed
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.
Time frame: Weekly during the 4-week intervention period and post-intervention, approximately 4 weeks after baseline.
Safety: adverse events
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.
Time frame: Continuously during the intervention period and at post-intervention and follow-up assessments, up to approximately 8 weeks after baseline.
Technical feasibility
Frequency, type, and impact of technical incidents affecting online intervention delivery, participant participation, or online data collection.
Time frame: Continuously during the intervention period and assessment windows, up to approximately 8 weeks after baseline.
Change in functioning assessed by the Spanish version of the World Health Organization Disability Assessment Schedule 2.0
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.
Time frame: Baseline, post-intervention at approximately 4 weeks, and follow-up at approximately 8 weeks.
Change in quality of life assessed by the Spanish version of the World Health Organization Quality of Life-BREF
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.
Time frame: Baseline, post-intervention at approximately 4 weeks, and follow-up at approximately 8 weeks.
Change in occupational balance assessed by the Spanish version of the Occupational Balance Questionnaire
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.
Time frame: Baseline, post-intervention at approximately 4 weeks, and follow-up at approximately 8 weeks.
Change in hand function assessed by the Spanish version of the Cochin Hand Function Scale
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.
Time frame: Baseline, post-intervention at approximately 4 weeks, and follow-up at approximately 8 weeks.
Plan to share: No — 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.
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Universidad de Zaragoza