Health Interventions for Survivors and Primary Support Persons of Spinal Cord Injury (SCI)
Caregiver Intervention for Caregivers of SCI Patients
調査の概要
詳細な説明
The specific aims of this project are to:
- Assess the impact of a dual target (caregiver and care recipient) intervention compared to a traditional caregiver-only intervention strategy.
- Assess causal linkages between the treatment components (e.g. knowledge, social support) of a multi-component intervention and specific treatment outcomes (e.g. caregiver depression, quality of life).
- Explore cultural and racial differences in the evaluation of and effectiveness of the different treatment approaches.
Overall, the issues affecting management of SCI/D in later life are complex and hold critical implications for the health of the long-term survivor as well as for those who provide care in the home environment. Large numbers of individuals are living with the effects of SCI/D for decades post-injury. In addition to the health-related complications that typically accompany older age, these individuals are especially vulnerable to co-occurring medical conditions that require high degrees of support and maintenance. Consequently, older caregivers face multiple and often extreme challenges in providing support to the SCI/D survivor at a time in their lives when their own abilities may be compromised due to age-related changes in health and functioning.
The multi-faceted burden faced by caregivers is associated with high levels of depression and anxiety as well as the onset of deleterious physical symptoms. The cumulative effects of such multiple stressors over time all too frequently leave the caregiver unable to continue providing the level of support necessary to maintain their partner's health in the home environment. In order to circumvent the additional distress certain to accompany such a family separation, Elliott et al. (2001, p. 230) recently concluded that "there is a pressing need for interventions that help family [SCI] caregivers address the routines and tasks essential to maintaining family functioning."
研究の種類
入学 (実際)
段階
- フェーズ2
- フェーズ 3
連絡先と場所
研究場所
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Florida
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Miami、Florida、アメリカ、33136
- University of Miami
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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15260
- University of Pittsburgh (UCSUR)
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria (Survivors):
- have adult-onset disability resulting from spinal cord injury, trauma, or disease,
- be survivors with complete or incomplete injury as defined by the American Spinal Injury Association (ASIA) impairment scale
- require and use some type of assistance for getting around (e.g., wheelchair, cane, etc.) be 30 years old or older be living at home for a minimum of 1 year post-injury (to avoid the acute trauma phase) speak English.
Inclusion Criteria (Caregivers):
- Is a family member/partner (e.g. spouse, child, or fictive kin)
- is 18 years of age or older
- is or is not living with the care recipient
- speaks English
- has a telephone at home
- plans to live in the area for at least 6 months.
- self-identifies as white, African American or Hispanic.
Exclusion Criteria:
- has a terminal illness with life expectancy of less than 6 months
- is in active treatment for cancer (except for tamoxifen and lupron)
- is blind or deaf
- if the survivor is cognitively impaired due to brain injury or dementia and/or has no use of their hands and severe limitations in speech production
研究計画
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
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：Caregiver Only
A multi-component psycho-educational intervention designed to reduce the negative emotional and behavioral responses of the caregiver and reduce the risk of mental and physical health problems.
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A multi-component psycho-educational intervention designed to reduce the negative emotional and behavioral responses of the caregiver and reduce the risk of mental and physical health problems.
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実験的：Dual Treatment
Complements the caregiver only intervention by targetting both caregiver and SCI person with multi-component psycho-educational intervention
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Complements the caregiver only intervention by targetting both caregiver and SCI person with multi-component psycho-educational intervention
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アクティブコンパレータ：Control
Participants are provided with written materials at beginning of study; nothing thereafter
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Participants given written educational materials at beginning of study; no treatment beyond this
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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 |
時間枠 |
|---|---|
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Depressive symptoms caregivers and SCI
時間枠：6 and 12 months post-randomization
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6 and 12 months post-randomization
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Caregiver Burden
時間枠：6 and 12 months
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6 and 12 months
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Social support caregiver and SCI
時間枠：6 and 12 months
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6 and 12 months
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Health symptoms caregiver and SCI
時間枠：6 and 12 months
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6 and 12 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Richard Schulz, PhD、University of Pittsburgh
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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。
脊髄損傷の臨床試験
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Memorial Sloan Kettering Cancer CenterUniversity of Pisa; University of California, San Francisco; The Champalimaud Centre, Lisbon,...積極的、募集していないメラノーマ | 肉腫 | 卵巣がん | 骨 | 軟部組織 | リンパ節 | CNS-Spinal CD/MEMBR、NOSアメリカ, イタリア, ポルトガル
Caregiver Only Interventionの臨床試験
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University of MichiganNational Institute on Drug Abuse (NIDA)募集
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University of PittsburghCenters for Disease Control and Preventionまだ募集していません暴力, ドメスティック | 思春期の暴力 | 暴力、性的 | 暴力、身体的 | 暴力, 偶然ではない | 社会的結束 | 暴力、構造 | コミュニティ内暴力アメリカ
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University of California, San FranciscoSan Francisco Veterans Affairs Medical Center; Tobacco Related Disease Research Program完了
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University of Southern CaliforniaNational Institutes of Health (NIH)積極的、募集していない
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Massachusetts General HospitalNational Institutes of Health (NIH); Samaritans of Bostonまだ募集していません自殺念慮 | 自殺未遂 | 自殺