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.
調査の概要
状態
積極的、募集していない
詳細な説明
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.
研究の種類
介入
入学 (実際)
24
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Zaragoza / Aragón
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Zaragoza、Zaragoza / Aragón、スペイン、50009
- Universidad de Zaragoza
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Feasibility: intervention completion
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Acceptability: session satisfaction
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
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Change in functioning assessed by the Spanish version of the World Health Organization Disability Assessment Schedule 2.0
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Sandra M Espín Tello, PhD、Universidad de Zaragoza
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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- 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.
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- 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.
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年5月16日
一次修了 (推定)
2026年7月1日
研究の完了 (推定)
2026年8月1日
試験登録日
最初に提出
2026年6月10日
QC基準を満たした最初の提出物
2026年6月16日
最初の投稿 (実際)
2026年6月22日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月22日
QC基準を満たした最後の更新が送信されました
2026年6月16日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- C.I. PI26/254
- 216213 (その他の助成金/資金番号：Asociación Española de Esclerodermia)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。