Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Personalized Online Occupational Therapy Intervention for Adults With Scleroderma

16. juni 2026 opdateret af: 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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

24

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Spanien
    • Zaragoza / Aragón
      • Zaragoza, Zaragoza / Aragón, Spanien, 50009
        • Universidad de Zaragoza

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: Personalized 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.
Aktiv komparator: 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.
Andet: Usual 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Feasibility: intervention completion
Tidsramme: 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.
From baseline to post-intervention, approximately 4 weeks.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Acceptability: session satisfaction
Tidsramme: 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.
After each intervention session during the 4-week intervention period.
Acceptability: final intervention satisfaction questionnaire score
Tidsramme: 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.
Post-intervention, approximately 4 weeks after baseline.
Complementary adherence: Percentage of expected weekly diaries completed
Tidsramme: 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.
Weekly during the 4-week intervention period.
Complementary adherence: Percentage of agreed home-based tasks completed
Tidsramme: 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.
Weekly during the 4-week intervention period and post-intervention, approximately 4 weeks after baseline.
Complementary adherence: Percentage of intervention materials reviewed
Tidsramme: 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.
Weekly during the 4-week intervention period and post-intervention, approximately 4 weeks after baseline.
Safety: adverse events
Tidsramme: 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.
Continuously during the intervention period and at post-intervention and follow-up assessments, up to approximately 8 weeks after baseline.
Technical feasibility
Tidsramme: 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.
Continuously during the intervention period and assessment windows, up to approximately 8 weeks after baseline.

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in functioning assessed by the Spanish version of the World Health Organization Disability Assessment Schedule 2.0
Tidsramme: 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.
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
Tidsramme: 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.
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
Tidsramme: 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.
Baseline, post-intervention at approximately 4 weeks, and follow-up at approximately 8 weeks.
Change in hand function assessed by the Spanish version of the Cochin Hand Function Scale
Tidsramme: 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.
Baseline, post-intervention at approximately 4 weeks, and follow-up at approximately 8 weeks.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Universidad de Zaragoza

Samarbejdspartnere

Asociación Española de Esclerodermia

Efterforskere

  • Ledende efterforsker: Sandra M Espín Tello, PhD, Universidad de Zaragoza

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

16. maj 2026

Primær færdiggørelse (Anslået)

1. juli 2026

Studieafslutning (Anslået)

1. august 2026

Datoer for studieregistrering

Først indsendt

10. juni 2026

Først indsendt, der opfyldte QC-kriterier

16. juni 2026

Først opslået (Faktiske)

22. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • C.I. PI26/254
  • 216213 (Andet bevillings-/finansieringsnummer: Asociación Española de Esclerodermia)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Sklerodermi

Kliniske forsøg med Personalized Online Occupational Therapy Intervention

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Philippines

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner