Last updated: 02/07/2020 16:20:04
Prostate Research On Behaviour & Education (PROBE II) Survey. Cross-sectional, multinational, qualitative study to explore and identify patient and healthcare provider attitudes to benign prostatic hyperplasia in Asia Pacific, Latin America, and Commonwealth of Independent States (CIS)
GSK study ID
201156
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Prostate Research On Behaviour & Education (PROBE II) Survey. Cross-sectional, multinational, qualitative study to explore and identify patient and healthcare provider attitudes to benign prostatic hyperplasia in Asia Pacific, Latin America, and Commonwealth of Independent States (CIS)
Trial description: PROBE II is a multi-country qualitative questionnaire based survey to look into BPH attitudes and behaviours of patients and physicians. The study will be conducted by inviting a sample of physicians and BPH patients to complete relevant questionnaires in order to address the study objectives.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Patient Questionnaire
Timeframe: The questionnaire is completed at first and only study visit. The questionnaire can be completed in person by phone or online.
Secondary outcomes:
Patient Questionnaire. Patient' pers;ective of physicians role
Timeframe: The questionnaire is completed at first and only study visit. The questionnaire can be completed in person by phone or online.
Physician Questionnaire. explore treatment options
Timeframe: The questionnaire is completed at first and only study visit. The questionnaire can be completed in person by phone or online.
Patient Questionnaire. Patient's attitude of symtoms
Timeframe: The questionnaire is completed at first and only study visit. The questionnaire can be completed in person by phone or online.
Physicians Questionnaire.awareness of patients perception of BPH
Timeframe: The questionnaire is completed at first and only study visit. The questionnaire can be completed in person by phone or online.
Patient Questionnaire. PBPH health seeking behaviour
Timeframe: The questionnaire is completed at first and only study visit. The questionnaire can be completed in person by phone or online.
Patint Questionnaire. Patient's current adhererence to medication
Timeframe: The questionnaire is completed at first and only study visit. The questionnaire can be completed in person by phone or online.
Physicians Questionnaire. PBH Dianostic tools
Timeframe: The questionnaire is completed at first and only study visit. The questionnaire can be completed in person by phone or online.
Interventions:
Other: Physician Questionnaire
Other: Patient Questionniare
Enrollment:
114
Observational study model:
Cohort
Primary completion date:
2015-14-09
Time perspective:
Retrospective
Clinical publications:
Phillip Ertel; Ipek Demircan; Michael Manyak; Burkay Adalig; Belinda Lartey . Prostate Research on Behaviour and Education (PROBE II) survey. Int J Clin Pract. 2016;70(10):870-880.
Medical condition
Prostatic Hyperplasia
Product
dutasteride, dutasteride/tamsulosin, tamsulosin
Collaborators
Not applicable
Study date(s)
December 2014 to September 2015
Type
Observational
Phase
4
Participation criteria
Sex
Male
Age
45 - 80 Year
Accepts healthy volunteers
none
- Physicians eligible for enrolment in the study must meet all of the following criteria:
- Physicians must have been practising Urologists (or GPs in Australia) for 3 or more years but less than 31 years to have the most appropriate experience to help answer objectives.
- Physicians meeting any of the following criteria must not be enrolled in the study:
- Physicians have been practising Urologists for under 3 years and more than 30 years.
Inclusion and exclusion criteria
Inclusion criteria:
- Physicians eligible for enrolment in the study must meet all of the following criteria:
- Physicians must have been practising Urologists (or GPs in Australia) for 3 or more years but less than 31 years to have the most appropriate experience to help answer objectives.
- Physicians have to see (diagnose or treat) at least 5 patients with BPH per month in their practice.
- Physicians who consented to take part in the study in writing and are willing to provide their responses in the study questionnaire
- Australia country-specific inclusion criterion: Physicians must have been practising General Practitioners for 3 or more years but less than 31 years to have the most appropriate experience to help answer objectives and provide care to patients with BPH on a regular basis. Patients eligible for enrolment in the study must meet all of the following criteria:
- All patients have to be male, aged 45-80 years old at the time of the interview.
- Patient self-reported previous diagnosis of BPH (or ‘enlarged prostate’, or ‘prostate problems’) set by physician.
- Patient self-reported consultation of a physician for BPH (or ‘enlarged prostate’, or ‘prostate problems’) during the last 12 months.
- Known current use of prescription medication for BPH (or ‘enlarged prostate’, or ‘prostate problems’).
- Fluent and literate in local language with the ability to read, comprehend and record information.
- Patients who are physically and/or mentally capable to understand and respond to the study questionnaire.
- Patients, who have provided their consent to take part in the study in writing and are willing to provide their responses in the study questionnaire.
Exclusion criteria:
- Physicians meeting any of the following criteria must not be enrolled in the study:
- Physicians have been practising Urologists for under 3 years and more than 30 years.
- Recent (within the last 3 months) participation in any market or clinical research study in prostate health.
- Existing paid affiliation with a healthcare or pharmaceutical organisation as a consultant or clinical researcher. They are also excluded if any direct member of the physician’s family has a paid affiliation with a pharmaceutical organisation as consultant or clinical researcher.
- Physicians, who have not provided their consent to take part in the study in writing and/or are not willing to provide their responses in the study questionnaire
- Australia country-specific exclusion criterion: Physicians have been practising General Practitioners for under 3 years and more than 30 years or do not provide care to patients with BPH on a regular basis. Patients meeting any of the following criteria must not be enrolled in the study:
- Gender: female.
- Age: less than 45 full years or more than 80 full years of age.
- Patients who have not provided their consent to take part in the study in writing and/or are not willing to provide their responses in the study questionnaire.
- Patients, who undergone prostatectomy due to any reasons (BPH progression, prostate cancer etc.).
- Patients with history of prostate cancer.
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Finalized
Actual primary completion date
2015-14-09
Actual study completion date
2015-14-09
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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