Increasing Decision Quality for Men With Lower Urinary Tract Symptoms
Increasing Decision Quality in Older Men in Selecting Treatment Options for Lower Urinary Tract Symptoms (LUTS): A Pilot Randomized Controlled Trial
調査の概要
状態
詳細な説明
Lower urinary tract symptoms (LUTS), often related to prostatomegaly, is common but seldom sought medical attention amongst older men. Visual-aid and shared decision-making (SDM) are potential solutions to address LUTS. The study aimed to determine the effect of a novel pictorial Visual Analogue Uroflowmetry Score (VAUS) and primary care physicians (PCP) SDM training on the decisional quality amongst men selecting their treatment options for LUTS.
This study recruited 60 multi-ethnic Asian men aged ≥50 years with moderate-to-severe LUTS (International Prostate Symptoms Score≥8 and/or QOL≥3) in a Singapore public primary care clinic. Men used the VAUS to report their symptoms. 60 men were randomly assigned to PCPs trained in SDM in the intervention group (n=30) and the other 30 to the control group (PCPs without SDM-training). Patient-physician dyad decision quality was measured using the validated SDMQ-9 (patient) and SDMQ-Doc (physician) questionnaires.
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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Singapore、シンガポール、150167
- Haidee Ngu
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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:
- men aged 50 years old and older attending the polyclinic for routine follow up of a chronic disease (non-communicable disease)
- have moderate-to-severe LUTS and/or poor quality of life (QOL) as assessed by the validated International Prostate Symptom Score (IPSS) of eight or more and/or its individual QOL score of three or more
- men of any local Asian ethnicity and were willing to provide written consent
- can communicate with their allocated PCP in either of the three main local languages; English, Mandarin or Malay.
Exclusion Criteria:
- have indwelling catheters
- urinary incontinence requiring diapers
- anuria due to any renal pathology
- gross hematuria
- acute urinary retention
- symptoms consistent with an acute urinary tract infection
- existing treatment of LUTS or other prostate pathology
- visual or hearing impairment which render men incapable of understanding the study procedure and providing informed consent
- men unwilling to discuss their LUTS treatment options with their PCP
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：ヘルスサービス研究
- 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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実験的：Shared decision making for men with lower urinary tract symptoms
Participants used the Visual Analogue Uroflowmetry Score so report their symptoms and were attended by Primary Care Physicians trained in shared decision making
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Physicians in this group were trained in shared decision making
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アクティブコンパレータ：No shared decision making for men with lower urinary tract symptoms
Participants did not use the Visual Analogue Uroflowmetry Score to report their symptoms and received usual care by Primary Care Physicians not trained in shared decision making
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Physicians did not receive training in shared decision making
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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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Quality of the decision on the management of lower urinary tract symptoms from the patients' perspective
時間枠：Through study completion, an average of 6 months
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The Shared Decision Making-9 (SDMQ9) Questionnaire measures decision quality from the perspective of the patient.
Nine individual items in the questionnaire is scored from 0 to 5 on a six-point Likert scale ranging from 0 ("completely disagree") to 5 ("completely agree").
Standard scoring for the full scale is the total score, with values from 0 to 45. Higher scores indicate higher quality decisions.
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Through study completion, an average of 6 months
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Quality of the decision on the management of lower urinary tract symptoms from the physicians' perspective
時間枠：Through study completion, an average of 6 months
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The Shared Decision Making-Doctor (SDMQDoc) Questionnaire measures decision quality from the perspective of the physician.
Nine individual items in the questionnaire is scored from 0 to 5 on a six-point Likert scale ranging from 0 ("completely disagree") to 5 ("completely agree").
Standard scoring for the full scale is the total score, with values from 0 to 45. Higher scores indicate higher quality decisions.
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Through study completion, an average of 6 months
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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Tan Ngiap Chuan, MBBS、Singhealth polyclinic
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 (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 (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
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。