Gout Self-Monitoring Aiming to Reach Target (Gout-SMART)
Gout Self-Monitoring Aiming to Reach Target Serum Urate (Gout-SMART): Feasibility Study of Supported Self-management of Gout in Secondary Care Patients Requiring Escalation of Urate Lowering Therapy
調査の概要
詳細な説明
Gout is the most common cause of inflammatory arthritis with recurrent gout flares a cause of reduced quality of life, work absence and disability. Effective treatments are widely available and yet many patients never achieve control of their disease. Resolution of gout attacks requires sustained lowering of the levels of serum urate, which in practise is seldom achieved. A supported self-management approach to gout has been developed which incorporates self-testing of urate levels and a smartphone application that will prompt participants to self-test and allow clinical researchers to titrate urate lowering therapies.
The feasibility of this approach will be evaluated in patients with gout referred to secondary care. Participants will be randomised 2:1 to the intervention or a control group. The intervention group will be offered supported self-management incorporating self-testing of serum urate. The control group will receive usual care from their primary care physician. The primary outcome will be the proportion of patients achieving levels of serum urate at or below 0.3mmol/l by 6 months. Participants will be followed up for a total of 12 months to assess the broader health and economic impact of the intervention.
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
-
-
-
Edinburgh、イギリス、EH4 2XU
- Western General Hospital
-
-
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:
- Confirmed diagnosis of gout (as per American College of Rheumatology criteria)
- Physician recommendation that escalation of urate lowering therapy with allopurinol or febuxostat is appropriate.
- Serum urate >0.36mm/L.
- Patient has a mobile phone and is able to install GoutSMART application.
Exclusion Criteria:
- Subject is unable to provide consent
- Severe renal failure (eGFR <30) or established liver disease
- Previous adverse reaction to allopurinol or febuxostat
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Supported self-management
Escalation of urate lowering therapy will be supervised by clinical research team based on results of participant self-testing
|
Participants will be supplied with urate self-testing kits.
Participants will have a mobile phone application installed which will prompt the participant to perform urate self-testing, enable the clinical research team to advise on escalation of urate lowering therapy, and collect quality of life data .
|
|
偽コンパレータ：Usual care
Escalation of urate lowering therapy will remain the responsibility of the participants primary care physician.
|
Participants will have a mobile phone application installed which will allow the research team to collect quality of life data.
|
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 |
|---|---|---|
|
Proportion of participants achieving target urate levels (24 weeks)
時間枠：24 weeks
|
Proportion of participants achieving serum urate level at, or below, 0.3mmol/l
|
24 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of participants achieving target urate levels (52 weeks)
時間枠：52 weeks
|
Proportion of participants achieving serum urate level at, or below, 0.3mmol/l
|
52 weeks
|
|
Flare frequency
時間枠：52 weeks
|
Prospectively gathered number of days of self-reported gout flares
|
52 weeks
|
|
Size of tophi
時間枠：52 weeks
|
The size in mm of the largest tophus at baseline (index tophus) will be measured at 52 weeks
|
52 weeks
|
|
Presence of tophi
時間枠：52 weeks
|
The number of clinically evident tophi will be evaluated at 52 weeks
|
52 weeks
|
|
Patient reported quality of life using EQ-5D-5L
時間枠：52 weeks
|
Prospectively gathered self-reported quality of life during/following gout flare evaluated using the EQ-5D-5L questionnaire.
|
52 weeks
|
|
Work absences
時間枠：52 weeks
|
Prospectively gathered data on days lost at work due to gout flare
|
52 weeks
|
|
Healthcare utilisation
時間枠：52 weeks
|
Prospectively gathered number of scheduled and unscheduled medical appointments/ hospital admissions due to gout
|
52 weeks
|
|
Self-reported medication compliance (24 weeks)
時間枠：24 weeks
|
Self report of number of doses of medication omitted in preceding 2 weeks will be collected at 24 weeks.
|
24 weeks
|
|
Self-reported medication compliance (52 weeks)
時間枠：52 weeks
|
Self report of number of doses of medication omitted in preceding 2 weeks will be collected at 52 weeks
|
52 weeks
|
|
Medication compliance (24 weeks)
時間枠：24 weeks
|
Plasma oxypurinol levels will be measured at 24 weeks.
|
24 weeks
|
|
Medication compliance (52 weeks)
時間枠：52 weeks
|
Plasma oxypurinol levels will be measured at 52 weeks.
|
52 weeks
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Philip L Riches, FRCP PhD、University of Edinburgh/NHS Lothian
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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 (実際)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- GoutSMART_NHSL_2YCR
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?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- 研究プロトコル
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。
Supported self-managementの臨床試験
-
Alexandria University完了
-
University of California, San FranciscoNational Cancer Institute (NCI)完了
-
Brigham and Women's Hospital積極的、募集していない
-
Indiana University引きこもった
-
Centre Hospitalier Universitaire de Nīmes完了
-
Medstar Health Research InstituteAmenity Health, Inc.終了しました