ID

36132

Descrição

We will conduct a two-site, randomized controlled trial to assess the efficacy of motor skill-based behavioral therapy (PFME) to treat urinary symptoms in adults with Parkinson Disease (PD). After stratification by urinary incontinence severity, PD severity, and gender, a group of 60 subjects (30 in each group) will be randomized to receive behavioral therapy or a behavioral control over 8 weeks in order to achieve a sample size of 50 individuals (25 in each group) who complete the study. A 6-month follow-up is planned in the treatment group. ODM derived from: https://clinicaltrials.gov/show/NCT01520948

Link

https://clinicaltrials.gov/show/NCT01520948

Palavras-chave

  1. 17/04/2019 17/04/2019 -
  2. 17/04/2019 17/04/2019 -
Titular dos direitos

Atlanta VA Medical Center

Transferido a

17 de abril de 2019

DOI

Para um pedido faça login.

Licença

Creative Commons BY-NC 3.0

Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Behavioral Therapy to Treat Urinary Symptoms in Parkinson Disease (BETTUR PD) NCT01520948

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
Patient with clinical diagnosis of parkinson's disease determined by a board-certified neurologist with specialty training in movement disorders
Descrição

Diagnosis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0030567
UMLS CUI [1,3]
C1301908
UMLS CUI [1,4]
C1704211
UMLS CUI [1,5]
C0026650
Patient with ≥ 4 weekly episodes of urinary incontinence and at least one episode per week associated with feelings of urgency
Descrição

urgency is defined as the complaint of a sudden compelling desire to void which is difficult to defer

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0042024
UMLS CUI [1,2]
C0332174
UMLS CUI [2,1]
C0085606
UMLS CUI [2,2]
C1527305
UMLS CUI [2,3]
C0332174
Patient is willing to attend clinic visits
Descrição

Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0008952
UMLS CUI [1,2]
C1999232
UMLS CUI [1,3]
C0600109
Patient is willing to keep 7-day bladder diaries throughout the study period
Descrição

Protocol behaviour

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2216446
UMLS CUI [1,2]
C3273494
UMLS CUI [1,3]
C2347804
UMLS CUI [1,4]
C0600109
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
Patient with significant cognitive impairment, as indicated by a montreal cognitive assessment (moca) score of < 18.
Descrição

Cognitive impairment

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0338656
UMLS CUI [2]
C4721272
Patient is not able to produce an interpretable 7-day bladder diary at baseline
Descrição

Protocol behaviour

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2216446
UMLS CUI [1,2]
C3273494
UMLS CUI [1,3]
C2347804
UMLS CUI [1,4]
C4048706
Patient with previous intensive PFME training
Descrição

PFME = motor skill-based behavioral therapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0004933
UMLS CUI [1,2]
C0237543
UMLS CUI [1,3]
C1514463
Patient with clinically significant depression as measured by a geriatric depression scale-short form score ≥ 10 which could affect motivation to fully engage in the intervention
Descrição

Depression

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0026605
UMLS CUI [1,4]
C2348568
UMLS CUI [2]
C2919385
Patient uses an indwelling urinary catheter
Descrição

Indwelling urinary catheter

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0521197
Patient with bladder outlet obstruction defined as having been prescribed in-and-out catheterization in the past 12 months, having a post-void residual urine volume by bladder ultrasound of ≥ 200 ml or a peak voiding flow rate of ≤ 4 ml/min on a void ≥ 125 ml in volume
Descrição

Bladder outlet obstruction

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0447585
UMLS CUI [1,2]
C0028778
UMLS CUI [2]
C0150397
UMLS CUI [3,1]
C0080274
UMLS CUI [3,2]
C0429770
UMLS CUI [3,3]
C0041618
UMLS CUI [4]
C0200008
Patient with severe uterine prolapse past the vaginal introitus
Descrição

Gynecological conditions

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0042140
UMLS CUI [1,2]
C0458952
Patient with poorly controlled diabetes defined by a hemoglobin a1c (hgba1c) of >8.0%
Descrição

Diabetes

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0554876
UMLS CUI [2]
C0474680
chronic renal failure and on hemodialysis
Descrição

Renal function

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0022661
UMLS CUI [1,2]
C0019004
Patient with poorly controlled congestive heart failure or poorly controlled chronic obstructive pulmonary disease on physical exam
Descrição

Cardio-pulmonary diseases

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C3853134
UMLS CUI [2,1]
C0024117
UMLS CUI [2,2]
C3853134
Patient with genitourinary cancer with ongoing surgical or external beam radiation treatment
Descrição

Genitourinary cancer

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0751569
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C1707479
UMLS CUI [2,1]
C0751569
UMLS CUI [2,2]
C1517033
UMLS CUI [2,3]
C1707479
Patient has any unstable health condition expected to result in hospitalization or death within in the next 3 months as determined by principal investigator.
Descrição

Unstable health condition

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C4062077
UMLS CUI [1,2]
C0019993
UMLS CUI [1,3]
C1517001
UMLS CUI [2,1]
C4062077
UMLS CUI [2,2]
C0011065
UMLS CUI [2,3]
C1517001

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Diagnosis
Item
Patient with clinical diagnosis of parkinson's disease determined by a board-certified neurologist with specialty training in movement disorders
boolean
C0011900 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
C1301908 (UMLS CUI [1,3])
C1704211 (UMLS CUI [1,4])
C0026650 (UMLS CUI [1,5])
Urinary incontinence
Item
Patient with ≥ 4 weekly episodes of urinary incontinence and at least one episode per week associated with feelings of urgency
boolean
C0042024 (UMLS CUI [1,1])
C0332174 (UMLS CUI [1,2])
C0085606 (UMLS CUI [2,1])
C1527305 (UMLS CUI [2,2])
C0332174 (UMLS CUI [2,3])
Compliance
Item
Patient is willing to attend clinic visits
boolean
C0008952 (UMLS CUI [1,1])
C1999232 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Protocol behaviour
Item
Patient is willing to keep 7-day bladder diaries throughout the study period
boolean
C2216446 (UMLS CUI [1,1])
C3273494 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0600109 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Cognitive impairment
Item
Patient with significant cognitive impairment, as indicated by a montreal cognitive assessment (moca) score of < 18.
boolean
C0338656 (UMLS CUI [1])
C4721272 (UMLS CUI [2])
Protocol behaviour
Item
Patient is not able to produce an interpretable 7-day bladder diary at baseline
boolean
C2216446 (UMLS CUI [1,1])
C3273494 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C4048706 (UMLS CUI [1,4])
Prior PFME- Training
Item
Patient with previous intensive PFME training
boolean
C0004933 (UMLS CUI [1,1])
C0237543 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
Depression
Item
Patient with clinically significant depression as measured by a geriatric depression scale-short form score ≥ 10 which could affect motivation to fully engage in the intervention
boolean
C1269683 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0026605 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C2919385 (UMLS CUI [2])
Indwelling urinary catheter
Item
Patient uses an indwelling urinary catheter
boolean
C0521197 (UMLS CUI [1])
Bladder outlet obstruction
Item
Patient with bladder outlet obstruction defined as having been prescribed in-and-out catheterization in the past 12 months, having a post-void residual urine volume by bladder ultrasound of ≥ 200 ml or a peak voiding flow rate of ≤ 4 ml/min on a void ≥ 125 ml in volume
boolean
C0447585 (UMLS CUI [1,1])
C0028778 (UMLS CUI [1,2])
C0150397 (UMLS CUI [2])
C0080274 (UMLS CUI [3,1])
C0429770 (UMLS CUI [3,2])
C0041618 (UMLS CUI [3,3])
C0200008 (UMLS CUI [4])
Gynecological conditions
Item
Patient with severe uterine prolapse past the vaginal introitus
boolean
C0042140 (UMLS CUI [1,1])
C0458952 (UMLS CUI [1,2])
Diabetes
Item
Patient with poorly controlled diabetes defined by a hemoglobin a1c (hgba1c) of >8.0%
boolean
C0554876 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
Renal function
Item
chronic renal failure and on hemodialysis
boolean
C0022661 (UMLS CUI [1,1])
C0019004 (UMLS CUI [1,2])
Cardio-pulmonary diseases
Item
Patient with poorly controlled congestive heart failure or poorly controlled chronic obstructive pulmonary disease on physical exam
boolean
C0018802 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0024117 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
Genitourinary cancer
Item
Patient with genitourinary cancer with ongoing surgical or external beam radiation treatment
boolean
C0751569 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C1707479 (UMLS CUI [1,3])
C0751569 (UMLS CUI [2,1])
C1517033 (UMLS CUI [2,2])
C1707479 (UMLS CUI [2,3])
Unstable health condition
Item
Patient has any unstable health condition expected to result in hospitalization or death within in the next 3 months as determined by principal investigator.
boolean
C4062077 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C1517001 (UMLS CUI [1,3])
C4062077 (UMLS CUI [2,1])
C0011065 (UMLS CUI [2,2])
C1517001 (UMLS CUI [2,3])

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial