Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07661836

Personalized Online Occupational Therapy Intervention for 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Scleroderma Connective Tissue Diseases Scleroderma (Limited and Diffuse) Scleroderma, Diffuse Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases Systemic Sclerosis (SSc)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Zaragoza

Zaragoza, Zaragoza / Aragón, 50009, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Personalized Online Occupational Therapy Intervention

Behavioral

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

Other

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.

Primary outcomes

  1. Feasibility: intervention completion

    Time frame: From baseline to post-intervention, approximately 4 weeks.

    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.

Secondary outcomes

  1. Acceptability: session satisfaction

    Time frame: After each intervention session during the 4-week intervention period.

    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.

  2. Acceptability: final intervention satisfaction questionnaire score

    Time frame: Post-intervention, approximately 4 weeks after baseline.

    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.

  3. Complementary adherence: Percentage of expected weekly diaries completed

    Time frame: Weekly during the 4-week intervention period.

    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.

  4. Complementary adherence: Percentage of agreed home-based tasks completed

    Time frame: Weekly during the 4-week intervention period and post-intervention, approximately 4 weeks after baseline.

    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.

  5. Complementary adherence: Percentage of intervention materials reviewed

    Time frame: Weekly during the 4-week intervention period and post-intervention, approximately 4 weeks after baseline.

    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.

  6. Safety: adverse events

    Time frame: Continuously during the intervention period and at post-intervention and follow-up assessments, up to approximately 8 weeks after baseline.

    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.

  7. Technical feasibility

    Time frame: Continuously during the intervention period and assessment windows, up to approximately 8 weeks after baseline.

    Frequency, type, and impact of technical incidents affecting online intervention delivery, participant participation, or online data collection.

Other outcomes

  1. Change in functioning assessed by the Spanish version of the World Health Organization Disability Assessment Schedule 2.0

    Time frame: Baseline, post-intervention at approximately 4 weeks, and follow-up at approximately 8 weeks.

    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.

  2. Change in quality of life assessed by the Spanish version of the World Health Organization Quality of Life-BREF

    Time frame: Baseline, post-intervention at approximately 4 weeks, and follow-up at approximately 8 weeks.

    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.

  3. Change in occupational balance assessed by the Spanish version of the Occupational Balance Questionnaire

    Time frame: Baseline, post-intervention at approximately 4 weeks, and follow-up at approximately 8 weeks.

    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.

  4. Change in hand function assessed by the Spanish version of the Cochin Hand Function Scale

    Time frame: Baseline, post-intervention at approximately 4 weeks, and follow-up at approximately 8 weeks.

    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.

Sponsors and collaborators

Lead sponsor

Universidad de Zaragoza

Other

Collaborators

  • Asociación Española de Esclerodermia

Registry information

Official study title

Pilot Exploratory Parallel-Group Randomized Controlled Trial to Evaluate a Personalized Online Occupational Therapy Intervention Versus Usual Care in Adults With Scleroderma

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.