Personalized Online Occupational Therapy Intervention for Adults With Scleroderma

NCT07661836 | Active Not Recruiting DMC

• 2 other identifiers: C.I. PI26/254216213
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Scleroderma; Scleroderma (Limited and Diffuse); Systemic Sclerosis (SSc)

Keywords

Scleroderma; Systemic sclerosis; Occupational therapy; Telerehabilitation; Activities of daily living; Quality of life; Occupational balance; Hand function

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline to post-intervention, approximately 4 weeks.

Secondary Outcomes (7)

• 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.

Other Outcomes (4)

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

  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

  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

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

Study Arms (2)

Personalized Online Occupational Therapy Plus Usual Care

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

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

Interventions

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.

Personalized Online Occupational Therapy Plus 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.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Zaragoza: lead
• Asociación Española de Esclerodermia: collaborator

Study Sites (1)

Universidad de Zaragoza

Zaragoza, Zaragoza / Aragón, 50009, Spain

Location

Related Publications (6)

• 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.

  PMID: 21611868 BACKGROUND

• 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.

  PMID: 22609002 BACKGROUND

• 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.

  PMID: 15085902 BACKGROUND

• 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.

  PMID: 34299957 BACKGROUND

• 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.

  PMID: 20482853 BACKGROUND

• 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.

  PMID: 40294953 BACKGROUND

MeSH Terms

Conditions

Scleroderma, Diffuse; Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Sandra M Espín Tello, PhD

  Universidad de Zaragoza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Lecturer (PhD)

Model Details: 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.

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 22, 2026
• Study Start: May 16, 2026
• Primary Completion: July 1, 2026
• Study Completion: August 1, 2026
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)