Integrating Supportive Care in Cystic Fibrosis
2020年2月17日 更新者：Dio Kavalieratos, PhD、University of Pittsburgh
Integrating Supportive Care in Cystic Fibrosis: A Pilot Study
Individuals living with cystic fibrosis (CF) commonly report high symptom burden, poor quality of life, and additional psychosocial stressors; these burdens are particularly heightened in advanced stages of the disease.
Although supportive care (aka palliative care) has been shown to improve many of these outcomes among patients with illnesses such as cancer, no clinical trials to date have tested the impact of supportive care for patients with CF.
The purpose of this pilot randomized clinical trial study is to evaluate the feasibility, acceptability, and perceived effectiveness of an embedded supportive care intervention, whereby a supportive care specialist will be integrated within the usual care experience of patients with advanced CF.
The investigators will enroll 50 patients with advanced CF, who will be equally randomized to receive this embedded supportive care intervention or usual care.
Secondary measures include: patient quality of life, mood, coping style, satisfaction with care, and symptom burden.
This study will provide preliminary data to support the development of a larger, definitive, Phase III randomized clinical trial.
調査の概要
詳細な説明
As described above.
研究の種類
介入
入学 (実際)
50
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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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15213
- University of Pittsburgh
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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
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Ability to comprehend English
- Advanced CF
(Any of the following criteria will be indicative of "Advanced CF")
- Baseline supplemental oxygen requirement
- FEV1 ≤ 50%
- Baseline non-invasive mechanical ventilation requirement
- ≥ 2 hospitalizations in the past 12 months for respiratory complications related to CF
Exclusion Criteria:
- Prisoners
- Females who are pregnant
- Prior receipt of specialist SC services
- Cognitive impairments
- Patients younger than 18 years of age
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：なし（オープンラベル）
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：Usual Care
Patients randomized to the control arm of this study will continue to receive the standard of high-quality CF care provided to all patients at the UPMC CF Center.
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実験的：Supportive Care Intervention
Patients randomized to the intervention arm will receive a protocolized supportive care intervention from a palliative care nurse practitioner.
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Patients in the intervention arm of the study will see a SC specialist during regularly-scheduled CF clinic visits; per usual care, these visits should occur on a quarterly basis.
Using a structured intervention manual, these visits will span 30-60 minutes each.
Each visit will have a specific focus, such as: 1) comprehensive palliative care assessment; 2) symptom assessment and self-management; 3) advance care planning; and, 4) coping and resilience.
Patients requiring follow up with SC before the next CF appointment will receive telephone follow up or an extra SC visit at the discretion of the SC provider.
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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 of intervention
時間枠：Up to 9 months (+/- 4 weeks)
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Measured by: eligibility rate, approach-to-consent rate, approach-to-enroll rate, rate of missed intervention sessions, rate of missing data on patient-reported outcomes.
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Up to 9 months (+/- 4 weeks)
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Acceptability of intervention
時間枠：Up to 9 months (+/- 4 weeks)
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Measured by: proportion of participants who endorse the intervention as acceptable.
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Up to 9 months (+/- 4 weeks)
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Perceived effectiveness of intervention
時間枠：Up to 9 months (+/- 4 weeks)
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Measured by: proportion of participants who endorse that they believe the intervention to have been beneficial.
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Up to 9 months (+/- 4 weeks)
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Intervention fidelity
時間枠：Up to 9 months (+/- 4 weeks)
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Evaluate the fidelity of intervention delivery using structured visit checklists to be completed by the interventionist and research staff.
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Up to 9 months (+/- 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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Patient quality of life: Cystic Fibrosis Questionnaire-Revised (CFQ-R)
時間枠：Up to 9 months (+/- 4 weeks)
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Change in QOL from baseline as measured by the Cystic Fibrosis Questionnaire-Revised (CFQ-R) at 9 months.
Due to the pilot nature of this trial, this measure will not be used to assess the efficacy of the intervention.
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Up to 9 months (+/- 4 weeks)
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Patient mood
時間枠：Up to 9 months (+/- 4 weeks)
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Change in mood from baseline using the Hospital Anxiety and Depression Scale (HADS), reported at 0, 3, 6, 9 months.
Due to the pilot nature of this trial, this measure will not be used to assess the efficacy of the intervention.
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Up to 9 months (+/- 4 weeks)
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Coping style
時間枠：Up to 9 months (+/- 4 weeks)
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Change in coping style from baseline using the Brief COPE, reported at 0, 3, 6, 9 months.
Due to the pilot nature of this trial, this measure will not be used to assess the efficacy of the intervention.
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Up to 9 months (+/- 4 weeks)
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Satisfaction with care
時間枠：Up to 9 months (+/- 4 weeks)
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Change in satisfaction with care from baseline using the FAMCARE-P13, reported at 0, 3, 6, 9 months.
Due to the pilot nature of this trial, this measure will not be used to assess the efficacy of the intervention.
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Up to 9 months (+/- 4 weeks)
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Symptom burden
時間枠：Up to 9 months (+/- 4 weeks)
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Change in symptom burden from baseline using the Edmonton Symptom Assessment Scale (ESAS), reported at 0, 3, 6, 9 months.
Due to the pilot nature of this trial, this measure will not be used to assess the efficacy of the intervention.
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Up to 9 months (+/- 4 weeks)
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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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Healthcare utilization
時間枠：Up to 12 months
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The investigators will evaluate various measures of healthcare utilization, such as: ED visits, unplanned hospitalizations, and healthcare expenditures.
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Up to 12 months
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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：Dio Kavalieratos, PhD、Section of Palliative Care and Medical Ethics; Division of General Internal Medicine, University of Pittsburgh
- 主任研究者：Joseph Pilewski, MD、Pulmonary, Allergy, and Critical Care Medicine Division; University of Pittsburgh
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)
2016年3月2日
一次修了 (実際)
2018年11月29日
研究の完了 (実際)
2019年10月7日
試験登録日
最初に提出
2016年1月14日
QC基準を満たした最初の提出物
2016年1月26日
最初の投稿 (見積もり)
2016年1月29日
学習記録の更新
投稿された最後の更新 (実際)
2020年2月18日
QC基準を満たした最後の更新が送信されました
2020年2月17日
最終確認日
2020年2月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- IRB#: PRO14110168
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?
はい
IPD プランの説明
It is possible that the investigators may use the information obtained from this study in other research studies examining the treatment of Cystic Fibrosis.
This information may also be shared with other researchers here and at other research centers, but those researchers will never be provided with any personal identifiers that would allow them to learn participant's identity.
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。