Personalized Online Occupational Therapy Intervention for Adults With Scleroderma
2026年6月16日 更新者：Sandra Martina Espín Tello、Universidad de Zaragoza
Pilot Exploratory Parallel-Group Randomized Controlled Trial to Evaluate a Personalized Online Occupational Therapy Intervention Versus Usual Care in 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.
研究概览
地位
主动，不招人
详细说明
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.
研究类型
介入性
注册 (实际的)
24
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Zaragoza / Aragón
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Zaragoza、Zaragoza / Aragón、西班牙、50009
- Universidad de Zaragoza
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Personalized Online Occupational Therapy Plus Usual Care
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.
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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.
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有源比较器：Usual Care
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.
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Feasibility: intervention completion
大体时间：From baseline to post-intervention, approximately 4 weeks.
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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.
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From baseline to post-intervention, approximately 4 weeks.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Acceptability: session satisfaction
大体时间：After each intervention session during the 4-week intervention period.
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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.
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After each intervention session during the 4-week intervention period.
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Acceptability: final intervention satisfaction questionnaire score
大体时间：Post-intervention, approximately 4 weeks after baseline.
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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.
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Post-intervention, approximately 4 weeks after baseline.
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Complementary adherence: Percentage of expected weekly diaries completed
大体时间：Weekly during the 4-week intervention period.
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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.
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Weekly during the 4-week intervention period.
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Complementary adherence: Percentage of agreed home-based tasks completed
大体时间：Weekly during the 4-week intervention period and post-intervention, approximately 4 weeks after baseline.
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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.
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Weekly during the 4-week intervention period and post-intervention, approximately 4 weeks after baseline.
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Complementary adherence: Percentage of intervention materials reviewed
大体时间：Weekly during the 4-week intervention period and post-intervention, approximately 4 weeks after baseline.
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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.
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Weekly during the 4-week intervention period and post-intervention, approximately 4 weeks after baseline.
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Safety: adverse events
大体时间：Continuously during the intervention period and at post-intervention and follow-up assessments, up to approximately 8 weeks after baseline.
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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.
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Continuously during the intervention period and at post-intervention and follow-up assessments, up to approximately 8 weeks after baseline.
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Technical feasibility
大体时间：Continuously during the intervention period and assessment windows, up to approximately 8 weeks after baseline.
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Frequency, type, and impact of technical incidents affecting online intervention delivery, participant participation, or online data collection.
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Continuously during the intervention period and assessment windows, up to approximately 8 weeks after baseline.
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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Change in functioning assessed by the Spanish version of the World Health Organization Disability Assessment Schedule 2.0
大体时间：Baseline, post-intervention at approximately 4 weeks, and follow-up at approximately 8 weeks.
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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.
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Baseline, post-intervention at approximately 4 weeks, and follow-up at approximately 8 weeks.
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Change in quality of life assessed by the Spanish version of the World Health Organization Quality of Life-BREF
大体时间：Baseline, post-intervention at approximately 4 weeks, and follow-up at approximately 8 weeks.
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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.
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Baseline, post-intervention at approximately 4 weeks, and follow-up at approximately 8 weeks.
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Change in occupational balance assessed by the Spanish version of the Occupational Balance Questionnaire
大体时间：Baseline, post-intervention at approximately 4 weeks, and follow-up at approximately 8 weeks.
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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.
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Baseline, post-intervention at approximately 4 weeks, and follow-up at approximately 8 weeks.
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Change in hand function assessed by the Spanish version of the Cochin Hand Function Scale
大体时间：Baseline, post-intervention at approximately 4 weeks, and follow-up at approximately 8 weeks.
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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.
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Baseline, post-intervention at approximately 4 weeks, and follow-up at approximately 8 weeks.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Sandra M Espín Tello, PhD、Universidad de Zaragoza
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Garin O, Ayuso-Mateos JL, Almansa J, Nieto M, Chatterji S, Vilagut G, Alonso J, Cieza A, Svetskova O, Burger H, Racca V, Francescutti C, Vieta E, Kostanjsek N, Raggi A, Leonardi M, Ferrer M; MHADIE consortium. Validation of the "World Health Organization Disability Assessment Schedule, WHODAS-2" in patients with chronic diseases. Health Qual Life Outcomes. 2010 May 19;8:51. doi: 10.1186/1477-7525-8-51.
- Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310. doi: 10.1023/B:QURE.0000018486.91360.00.
- Lucas-Carrasco R. The WHO quality of life (WHOQOL) questionnaire: Spanish development and validation studies. Qual Life Res. 2012 Feb;21(1):161-5. doi: 10.1007/s11136-011-9926-3. Epub 2011 May 25.
- Peral-Gomez P, Lopez-Roig S, Pastor-Mira MA, Abad-Navarro E, Valera-Gran D, Hakansson C, Wagman P. Cultural Adaptation and Psychometric Properties of the Spanish Version of the Occupational Balance Questionnaire: An Instrument for Occupation-Based Research. Int J Environ Res Public Health. 2021 Jul 14;18(14):7506. doi: 10.3390/ijerph18147506.
- Chan AW, Boutron I, Hopewell S, Moher D, Schulz KF, Collins GS, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne DR, Farmer AJ, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson DJ, Vohra S, White IR, Hrobjartsson A. SPIRIT 2025 statement: updated guideline for protocols of randomised trials. BMJ. 2025 Apr 28;389:e081477. doi: 10.1136/bmj-2024-081477.
- Arreguin Reyes R, Lopez Lopez CO, Alvarez Hernandez E, Medrano Ramirez G, Montes Castillo Mde L, Vazquez-Mellado J. Evaluation of hand function in rheumatic disease. Validation and usefulness of the Spanish version AUSCAN, m-SACRAH and Cochin questionnaires. Reumatol Clin. 2012 Sep-Oct;8(5):250-4. doi: 10.1016/j.reuma.2012.03.005. Epub 2012 May 17.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年5月16日
初级完成 (估计的)
2026年7月1日
研究完成 (估计的)
2026年8月1日
研究注册日期
首次提交
2026年6月10日
首先提交符合 QC 标准的
2026年6月16日
首次发布 (实际的)
2026年6月22日
研究记录更新
最后更新发布 (实际的)
2026年6月22日
上次提交的符合 QC 标准的更新
2026年6月16日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他研究编号
- C.I. PI26/254
- 216213 (其他赠款/资助编号：Asociación Española de Esclerodermia)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
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.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.