- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04851275
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
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Singapore, 싱가포르, 150167
- Haidee Ngu
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Quality of the decision on the management of lower urinary tract symptoms from the patients' perspective
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 연구 책임자: Tan Ngiap Chuan, MBBS, Singhealth polyclinic
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .