Pressure Ulcer Prevention Study in SCI (PUPS)
Lifestyle Redesign for Pressure Ulcer Prevention in Spinal Cord Injury
調査の概要
詳細な説明
Medically serious pressure ulcers are a common complication of spinal cord injury (SCI), and are associated with high treatment costs and reduced quality of life. This study will examine the efficacy and cost-effectiveness of a promising lifestyle-based intervention designed to reduce the incidence of pressure ulcers among culturally diverse, community dwelling adults with SCI who have had serious pressure ulcers.
The intervention being tested, termed lifestyle redesign (LR), is based on prior SCI literature as well as on the results of a qualitative pilot study undertaken by our study group. This intervention targets several psychosocial mediating variables that have been shown to be important in prevention of pressure ulcers in daily living contexts. Participants assigned to the LR condition receive individualized in-home sessions, personal phone calls, and incident-based contacts for a 12-month period, followed by 12 months of no intervention. Participants in the control condition do not receive any study-based intervention, but (along with the LR group) have continuing access to the standard options for prevention and treatment that are available through Rancho Los Amigos National Rehabilitation Center.
In addition to identifying a pressure ulcer prevention strategy, the planned research will lead to the development of testable theoretical models of the intervening process mechanisms that link the intervention to pressure ulcer reduction.
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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-
California
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Downey、California、アメリカ、90242
- Rancho Los Amigos National Rehabilitation Center (RLANRC)
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Los Angeles、California、アメリカ、90033
- University of Southern California
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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:
- Spinal cord injury (paraplegia or tetraplegia)
- Non-ambulatory
- Able to undergo intervention and testing in English or Spanish
- At least 6 months post-injury
- History of at least one serious (Stage 3 or 4) pressure ulcer in the past 5 years
- Cognitively intact
- Personally expressed willingness to undertake recommended lifestyle changes for ulcer prevention.
- Can be reached by telephone.
- Reside in or within 100 miles of Rancho Los Amigos National Rehabilitation Center (Downey, CA) with no plans to relocate beyond this area.
- Agreement to participate and completion of consent form.
Exclusion Criteria:
- Present serious stage 4 pressure ulcer
- Participation in our preliminary research studies
- Participating in the neuromuscular stimulation study
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：防止
- 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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介入なし：コントロール
普段のお手入れ
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|
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実験的：Lifestyle Redesign
Occupational therapist led lifestyle redesign program to prevent pressure ulcers
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Individualized program for lifestyle redesign aimed at decreasing the risk of medically serious pressure ulcers led by licensed occupational therapists trained in the implementation of the lifestyle redesign program
他の名前：
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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 |
|---|---|---|
|
Incidence of serious pressure ulcers
時間枠：Throughout 12-month study intervention
|
New stage 3 or 4 pressure ulcers
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Throughout 12-month study intervention
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of ulcer related surgeries
時間枠：Throughout 12-month study intervention and 12-months post intervention period
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Surgical wound repair (flap, skin graft, girdlestone, other)
|
Throughout 12-month study intervention and 12-months post intervention period
|
|
Quality of life
時間枠：Throughout 12-month study intervention and 12-months post intervention period
|
Measured by the Medical Outcomes Study Short Form (SF-36)
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Throughout 12-month study intervention and 12-months post intervention period
|
|
Healthcare service utilization
時間枠：Throughout 12-month study intervention and 12-months post intervention period
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Estimated cost of healthcare services including inpatient, outpatient, ER, home healthcare, lab, imaging, etc.
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Throughout 12-month study intervention and 12-months post intervention period
|
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Incidence of serious pressure ulcers
時間枠：Throughout 12-months post intervention period
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New stage 3 or 4 pressure ulcers during the second study year
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Throughout 12-months post intervention period
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Life Satisfaction
時間枠：Throughout 12-month study intervention and 12-months post intervention period
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Measured by the Satisfaction with Life Scale (SWLS)
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Throughout 12-month study intervention and 12-months post intervention period
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協力者と研究者
捜査官
- 主任研究者：Florence Clark, PhD、University of Southern California
- 主任研究者：Salah Rubayi, MD、Rancho Los Amigos National Rehabilitation Center
出版物と役立つリンク
一般刊行物
- Pyatak EA, Blanche EI, Garber SL, Diaz J, Blanchard J, Florindez L, Clark FA. Conducting intervention research among underserved populations: lessons learned and recommendations for researchers. Arch Phys Med Rehabil. 2013 Jun;94(6):1190-8. doi: 10.1016/j.apmr.2012.12.009. Epub 2012 Dec 21.
- Blanche EI, Fogelberg D, Diaz J, Carlson M, Clark F. Manualization of occupational therapy interventions: illustrations from the pressure ulcer prevention research program. Am J Occup Ther. 2011 Nov-Dec;65(6):711-9. doi: 10.5014/ajot.2011.001172.
- Vaishampayan A, Clark F, Carlson M, Blanche EI. Preventing pressure ulcers in people with spinal cord injury: targeting risky life circumstances through community-based interventions. Adv Skin Wound Care. 2011 Jun;24(6):275-84; quiz 285-6. doi: 10.1097/01.ASW.0000398663.66530.46.
- Fogelberg D, Atkins M, Blanche EI, Carlson M, Clark F. Decisions and Dilemmas in Everyday Life: Daily Use of Wheelchairs by Individuals with Spinal Cord Injury and the Impact on Pressure Ulcer Risk. Top Spinal Cord Inj Rehabil. 2009 Fall;15(2):16-32. doi: 10.1310/sci1502-16.
- Clark F, Pyatak EA, Carlson M, Blanche EI, Vigen C, Hay J, Mallinson T, Blanchard J, Unger JB, Garber SL, Diaz J, Florindez LI, Atkins M, Rubayi S, Azen SP; PUPS Study Group. Implementing trials of complex interventions in community settings: the USC-Rancho Los Amigos pressure ulcer prevention study (PUPS). Clin Trials. 2014 Apr;11(2):218-29. doi: 10.1177/1740774514521904. Epub 2014 Feb 26.
- Carlson M, Vigen CLP, Rubayi S, Blanche EI, Blanchard J, Atkins M, Bates-Jensen B, Garber SL, Pyatak EA, Diaz J, Florindez LI, Hay JW, Mallinson T, Unger JB, Azen SP, Scott M, Cogan A, Clark F. Lifestyle intervention for adults with spinal cord injury: Results of the USC-RLANRC Pressure Ulcer Prevention Study. J Spinal Cord Med. 2019 Jan;42(1):2-19. doi: 10.1080/10790268.2017.1313931. Epub 2017 Apr 17.
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
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