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治験 NCT06677905 (SCIU2)（対象：脊髄損傷）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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トロント大学SCI&U Peer Health Coaching Program for Individuals Newly Discharged From Inpatient Rehabilitation (SCIU2)
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます！「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT06677905 (SCIU2) は 介入研究 臨床試験 で、脊髄損傷 に関するものです。現在は 募集中 で、2025年2月21日 から開始しています。76 名の参加者 の募集が計画されています。この治験は トロント大学 によって主催され、2026年12月31日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年9月5日 です。
概要
The goal of this clinical trial is to learn if the online program and web-based platform for delivery of self-management services to people with spinal cord injury (SCI) called "SCI & U" can support transitions from hospital to the community after injury. Specifically, can providing support from trained peer health coaches via the SCI & U web-based self-management program increase health self-management among those within three years of a spinal cord injury with a planned discharge to or living in the community with SCI for less than two years in the province of British Columbia, Canada or the state of Connecticut, United States.
The main question it aims to answer is:
• Does the SCI & U web-based self-management program lower emotional distress and increase self-efficacy Researchers will compare those who participate in SCI & U with those who receive usual peer support after 6 months to see if the SCI & U program improves self-management knowledge, skills and self-efficacy and decreases secondary complications
Participants will:
- engage in up to 14 online sessions, each of which lasts about an hour with a peer health coach trained in motivational interviewing, goal setting and brief action planning. During sessions, they may also review resources and create follow up plans on the online platform on health management topics
- complete an interviewer administered survey at baseline, 6 and 12 months
公式タイトル
SCI&U Peer Health Coaching Program for Individuals Newly Discharged From Inpatient Rehabilitation
疾患／病気
脊髄損傷その他の研究識別子
- SCIU2
- 977608
NCT番号
開始日
2025-02-21
最終更新日
2025-09-05
終了予定日
2026-12-31
目標参加者数
76
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集中
キーワード
peer support
self-management
spinal cord injury
newly injured
web-based program
self-management
spinal cord injury
newly injured
web-based program
主目的
支持療法
割付方法
無作為化
介入モデル
並行割当
盲検化
二重盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的SCI&U self-management program Following recruitment intervention participants will be scheduled for an orientation session to become better acquainted with the health coaching program and the associated platform's features. Participants will then be partnered with their peer health coach. In the first videoconference session, participants will identify priority issues related to their health and transitioning to home. They will work through goal-setting, problem solving and create action plans for behaviour change. Online coaching sessions are expected to cover a health-related topic and a self-management skill topic and will have an expected duration of 45 to 60 minutes. The selection of topics and the order will be determined jointly. | Web-based Spinal Cord Injury Self-management Program Peer health coaches will be recruited from the United Spinal Connecticut Chapter and SCI BC. They will be at least 5 years post-SCI and will be certified in brief action planning and in Mental Health First Aid.
Online coaching sessions are expected to cover a health-related topic (eg. bladder, bowel, skin, pain, healthy eating, physical activity or stress, anxiety and depression etc) and a self-management skill topic (eg.action planning, goal setting, problem-solving, mood management, navigating the health care system, communicating with health care providers). To ensure we meet the unique needs of participants, the coach and participant will determine jointly how many sessions to spend on a topic. In addition, coaches will be able to link relevant information and resources contained in the resource library to each session. |
実薬対照薬Wait list control Control group will be offered the existing peer support program from the United Spinal Connecticut Chapter or SCI BC | ピアサポート Existing peer support program from the United Spinal Connecticut Chapter or SCI BC |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Emotional Distress Subscale in Health Education Impact Questionnaire | The Emotional Distress construct measures overall negative affect including worry, depression and anger. | From baseline assessment to 6 months followup |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Health Directed Activities in Health Education Impact Questionnaire | From baseline assessment to 6 months followup | |
Positive and Active Engagement in Life in Health Education Impact Questionnaire | From baseline assessment to 6 months followup | |
Self-monitoring and Insight in Health Education Impact Questionnaire | From baseline assessment to 6 months followup | |
Constructive Attitudes and Approaches in Health Education Impact Questionnaire | From baseline assessment to 6 months followup | |
Skill and Technique Acquisition in Health Education Impact Questionnaire | From baseline assessment to 6 months followup | |
Social Integration and Support in Health Education Impact Questionnaire | From baseline assessment to 6 months followup | |
Health Services Navigation in Health Education Impact Questionnaire | From baseline assessment to 6 months followup | |
The Patient Activation Measure - (PAM) Survey | The Patient Activation Measure (PAM) is a commercial product which assesses an individual's knowledge, skill, and confidence for managing one's health and healthcare. The PAM survey measures patients on a 0-100 scale and can segment patients into one of four activation levels. Individuals who measure high on this assessment typically understand the importance of taking a pro-active role in managing their health and have the skills and confidence to do so. | From baseline assessment to 6 months followup |
Moorong Self-Efficacy Scale | Measures self-efficacy in performing functional activities of daily living in individuals with SCI.
Consists of two factors: daily activities (e.g., I can maintain my personal hygiene with or without help), and social functioning (e.g., I can enjoy spending time with my friends) | From baseline assessment to 6 months followup |
Secondary Conditions Scale | A 16-item self-report measure that targets secondary conditions associated with SCI that impact health on a 4-point scale from "not experienced in the last 3 months" to significant or chronic problem" | From baseline assessment to 6 months followup |
NIH Toolbox Loneliness Scale | From baseline assessment to 6 months followup | |
System Usability Scale | This scale was designed to evaluate the usability of interactive systems flexibly and expediently. | From baseline assessment to 6 months followup |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- 18 years and older, with a planned discharge to or living in community with SCI for no more than three years since injury and with the ability to speak and understand English
- not a member of or willing to become a member of SCI BC or SCIACT
トロント大学233 件のアクティブな治験を探索責任者
Susan Jaglal, 研究責任者, Professor, University of Toronto
試験中央連絡先
連絡先: Susan Jaglal, PhD, 416-946-8641, [email protected]
連絡先: Diana Pernigotti, 203-284-2910, [email protected]
2 2カ国の場所
Connecticut
Spinal Cord Injury Association of Connecticut, Milford, Connecticut, 06460, United States
Diana Pernigotti, 連絡先, 203-284-2910, [email protected]
募集中
Ontario
Department of Physical Therapy, University of Toronto, Toronto, Ontario, M5J 2L4, Canada
Susan Jaglal, PhD, 連絡先, 416-946-8641, [email protected]
募集中