Scleroderma, Scleroderma (Limited and Diffuse), Systemic Sclerosis (SSc)
Conditions
Keywords
Scleroderma, Systemic sclerosis, Occupational therapy, Telerehabilitation, Activities of daily living, Quality of life, Occupational balance, Hand function
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALPersonalized Online Occupational Therapy Intervention
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.
OTHERUsual 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.
Sponsors
Universidad de Zaragoza
Asociación Española de Esclerodermia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
Participants are individually randomized in a 1:1 ratio to either a personalized online occupational therapy intervention added to usual care or usual care alone.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: intervention completion | 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
| Measure | Time frame | Description |
|---|---|---|
| Acceptability: session satisfaction | 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. |
| Acceptability: final intervention satisfaction questionnaire score | 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. |
| Complementary adherence: Percentage of expected weekly diaries completed | 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. |
| Complementary adherence: Percentage of agreed home-based tasks completed | 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. |
| Complementary adherence: Percentage of intervention materials reviewed | 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. |
| Safety: adverse events | 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. |
| Technical feasibility | 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. |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORSandra M Espín Tello, PhD
Universidad de Zaragoza
Outcome results
None listed