Integrating Palliative Care for Patients With Idiopathic Pulmonary Fibrosis and Their Caregivers
Patients with Idiopathic Pulmonary Fibrosis (IPF) and their caregivers will be randomized to receive this intervention or usual care. The intervention will include information about the disease, self-management strategies, and introduction to advanced care planning in a format with enhanced content available across multiple domains (face-to-face, printed material, digital (tablet) delivered by an interventionist. The usual care group will be provided with routine printed patient education.
At the end of life, IPF patients and their caregivers experience stress, symptom burden, poor quality of life, and inadequate preparedness for end-of-life care planning. The proposed study will measure feasibility, acceptability, and impact of a Supportive Care intervention.
調査の概要
詳細な説明
Idiopathic Pulmonary Fibrosis (IPF) is a disease of aging associated with intense medical and financial burden and expected to grow in incidence within the US population. Median survival from diagnosis is 3.8 years, although some patients succumb to a rapid death within 6 months. New therapies have recently become available. While these medications slow the rate of pulmonary deterioration, they have no impact on ultimate survival or quality of life. Although transplantation is an effective surgical therapy, less than 20% of patients ever receive a lung transplant. The remaining 80% have few treatment options and a likely rapidly progressive downhill course. Despite the fatal prognosis, we have found that patients and caregivers often fail to understand the poor prognosis as the disease relentlessly progresses. At the end of life, IPF patients and their caregivers experience stress, symptom burden, poor quality of life, and inadequate preparedness for end-of-life care planning.
The proposed study will measure feasibility, acceptability, and impact of a Supportive Care intervention. Patients with IPF and their caregivers will be randomized to receive this intervention or usual care. The intervention will include information about the disease, self-management strategies, and introduction to advanced care planning in a format with enhanced content available across multiple domains (face-to-face, printed material, digital (tablet) delivered by an interventionist. The usual care group will be provided with routine printed patient education.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15213
- Dorothy P. and Richard P. Simmons Center for Interstitial Lung Disease
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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:
- 45 years or older
- Primary Diagnosis of with Idiopathic Pulmonary Fibrosis (IPF)
- Has a caregiver, 18 years or older (spouse/partner/child/family member/friend), willing to participate.
- Sees a Simmons Center Physician for usual IPF care.
Exclusion Criteria:
- less than 45 years
- Not diagnosed with IPF
- Has an unwilling caregiver, or a caregiver under 18.
- Does not see a Simmons Center Physician for usual IPF care.
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: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: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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他の:Intervention
Group will receive SUPPORT, an intervention that provides information about the disease, self-management strategies, and introduction to advanced care planning in a format with enhanced content available across multiple domains (face-to-face, printed material, and digitally (via use of a tablet) delivered by an interventionist.
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Members of this group will receive personal, enhanced printed materials, as well as face-to-face support, and digital information provided by the interventionist.
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他の:Usual Care
Group will receive usual standard-of-care, and be provided with currently available printed material for information about their illness.
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Subjects will receive their usual standard of care, including currently available printed patient material.
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 |
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Stress
時間枠:3 years
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Perceived Stress Scale at baseline and completion of study in patients and caregivers
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3 years
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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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Disease Preparedness
時間枠:3 years
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Survey to measure preparation for disease course at completion of study for patients and caregivers.
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3 years
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Knowledge
時間枠:3 years
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Survey to measure knowledge of IPF at baseline and study completion with patients and caregivers
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3 years
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Advance Care Planning
時間枠:3 years
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Survey to measure completion of advance care plan at study completion with patients
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3 years
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Quality of Dying and Death
時間枠:3 years
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Quality of Dying and Death for caregivers if patient deceased during study
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3 years
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Symptom Burden
時間枠:3 years
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Promis-29 to measure symptom burden in patients at baseline and study completion.
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3 years
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Health Related Quality of Life in IPF
時間枠:3 years
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ATAQ-IPF instrument to measure quality of life in patients at baseline and study completion.
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3 years
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Kathleen O Lindell, PhD, RN、Dorothy P. and Richard P. Simmons Center for ILD
出版物と役立つリンク
一般刊行物
- Lindell KO, Klein SJ, Veatch MS, Gibson KF, Kass DJ, Nouraie M, Rosenzweig MQ. Nurse-Led Palliative Care Clinical Trial Improves Knowledge and Preparedness in Caregivers of Patients with Idiopathic Pulmonary Fibrosis. Ann Am Thorac Soc. 2021 Nov;18(11):1811-1821. doi: 10.1513/AnnalsATS.202012-1494OC.
- Lindell KO, Nouraie M, Klesen MJ, Klein S, Gibson KF, Kass DJ, Rosenzweig MQ. Randomised clinical trial of an early palliative care intervention (SUPPORT) for patients with idiopathic pulmonary fibrosis (IPF) and their caregivers: protocol and key design considerations. BMJ Open Respir Res. 2018 Feb 19;5(1):e000272. doi: 10.1136/bmjresp-2017-000272. eCollection 2018.
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
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。
SUPPORTの臨床試験
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University of Wisconsin, MadisonAgency for Healthcare Research and Quality (AHRQ)募集
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Medical University of South CarolinaNational Center for Advancing Translational Sciences (NCATS)完了
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UConn HealthUniversity of Texas at Austin; Oregon Social Learning Center招待による登録
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University of HawaiiNational Institute on Minority Health and Health Disparities (NIMHD)完了
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Dana-Farber Cancer Institute引きこもった
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University of CalgaryAlberta Health services; University of Alberta; Covenant Health完了
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Women's College HospitalRyerson University引きこもった
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Columbia UniversityNational Institute of Nursing Research (NINR); Brigham and Women's Hospital完了