Pilot Exploratory Parallel-Group Randomized Controlled Trial to Evaluate a Personalized Online Occupational Therapy Intervention Versus Usual Care in Adults With Scleroderma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Feasibility: intervention completion
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants and the occupational therapist cannot be masked because of the nature of the intervention. The principal investigator generated, stored, and communicated the allocation sequence and is therefore not masked. The outcomes assessor/statistical analyst will work with the group variable coded and will remain masked to the meaning of the codes until the planned final analysis stage, unless unmasking is required for safety reasons.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Personalized Online Occupational Therapy Intervention (Behavioral)
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.
干预措施: Usual Care (Other)
结局指标
主要结局
Feasibility: intervention completion
时间窗: 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.
次要结局
- Acceptability: session satisfaction(After each intervention session during the 4-week intervention period.)
- Acceptability: final intervention satisfaction questionnaire score(Post-intervention, approximately 4 weeks after baseline.)
- Complementary adherence: Percentage of expected weekly diaries completed(Weekly during the 4-week intervention period.)
- Complementary adherence: Percentage of agreed home-based tasks completed(Weekly during the 4-week intervention period and post-intervention, approximately 4 weeks after baseline.)
- Complementary adherence: Percentage of intervention materials reviewed(Weekly during the 4-week intervention period and post-intervention, approximately 4 weeks after baseline.)
- Safety: adverse events(Continuously during the intervention period and at post-intervention and follow-up assessments, up to approximately 8 weeks after baseline.)
- Technical feasibility(Continuously during the intervention period and assessment windows, up to approximately 8 weeks after baseline.)
研究者
Sandra Martina Espín Tello
Principal Investigator and Lecturer (PhD)
Universidad de Zaragoza