Group-based Chronic Kidney Disease Care
調査の概要
詳細な説明
This two-group RCT will enroll 100 subjects, adolescents over or equal to 12 years of age, and men and women over age of 21, with stage 3-4 and 5 CKD from various causes including diabetes and hypertension. Patients will be recruited from the Montefiore Medical Center Nephrology. The primary aim will be to assess feasibility of the intervention.
Informed consent will be obtained on all subjects. All subjects with meet with one of the investigators who will verbally explain to them the purpose of the study and the alternatives.
Blood and 24 hr urine test will be collected to assess for sodium, phosphorus, and serum creatinine. These tests will be used for experimental purposes only and will be collected at enrollment and 6 months visit.
There will be two arms, an arm randomized to Group-based care attending monthly outpatient clinic visits as part of a group and the other to usual care who will see their provider once a month for 6 months.
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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New York
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Bronx、New York、アメリカ、10461
- Albert Einstein College of Medicine
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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:
- Adolescent Age ≥12 years old
- Sufficient hearing, vision, and proficiency in English or Spanish to comprehend low- literacy printed educational materials and participate in group sessions (assessed by provider)
- Adult: (¬>21 years): Systolic blood pressure >140 at two clinic visits in the past year or >160 at one visit and Adolescent: (12-21 years) systolic blood pressure >95 percentile (based on sex and age) at 2 clinic visits in the past year
- For adults: Stage 3-5 CKD (eGFR<60 ml/min/1.73m2)
- For adolescents: evidence of kidney damage (albuminuria, congenital anomalies of the kidney or urinary tract) and hypertension
- Prescription for anti-hypertensive medication (in adults)
- Unwillingness to accept random assignment
- Unwillingness to provide informed consent
Exclusion Criteria:
- Transplanted organ
- Rapidly deteriorating kidney function with the expectation for initiation of dialysis in less than 6 months
- Plans to relocate out of New York City in the next 6 months
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：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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実験的：Group-based Care
Participants who are randomized to group-based care will attend monthly outpatient clinic visits as part of a group of 8-10 patients with CKD and hypertension.
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There will be self-care activities, blood pressure measurements and other vitals, including discussion of specific topics initiated by the participants.
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介入なし：Usual Care
Participants who are randomized to usual care will see their provider on clinic days when there is no group meeting.
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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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Blood pressure control
時間枠：6 months
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The primary outcome will be blood pressure control (mean SBP <140 mmHg) as measured by 24-hour ambulatory blood pressure monitor.
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6 months
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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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Accelerometer
時間枠：6 months
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Evaluate effects of group-based care on physical activity
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6 months
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Medication Adherence
時間枠：6 months
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Measured by the Morisky 8-item Medication Adherence scale.
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6 months
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Quality of Life
時間枠：6 months
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We will collect quality of life measurements using the Peds QL in the adolescent group and the SF-36 in the adult sample.
We want to evaluate whether group-based care may lead to improved or worse reported quality of life in participants.
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6 months
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Health Resources and Services Administration (HRSA)
時間枠：6 months
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Evaluate patient and provider satisfaction
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6 months
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協力者と研究者
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 (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。
Group-based Careの臨床試験
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University of HawaiiNational Institute on Minority Health and Health Disparities (NIMHD)完了
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University Hospital, GhentUniversity Ghent募集
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New York UniversitySt. Luke's-Roosevelt Hospital Center完了
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New York UniversityIndiana University; Moi University完了
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Fondation Oeuvre de la Croix Saint-Simon引きこもった
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Boston Medical CenterNational Institute on Minority Health and Health Disparities (NIMHD); Center for Community Health...完了肥満 | 喘息 | 血圧 | 小児発達 | ヘルスケアの利用 | 児童虐待 | 医療格差 | 満たされていない基本的な社会的ニーズアメリカ