Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PSI04-01
Study information
Scientific title
Acronym
Study hypothesis
The objective was to determine whether the provision of detailed information about BPH treatment options and outcomes via an interactive video disk affected patient decision making.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Urological and genital diseases: benign prostatic hyperplasia (BPH)
Intervention
1. Video viewing
2. Standard care
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Providing detailed information about the risks and benefits of treatment via the interactive video did not significantly appear to affect treatment choice. The interactive video was considered acceptable and easy to understand by patients, and despite the lack of a statistically significant difference in treatment choice, we cannot exclude the possibility that important shifts in the decision making process may occur, when a video such as this is introduced into clinical practice.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/10/1994
Overall trial end date
01/02/1999
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients from the Urology Department at Ashford Hospital, Middlesex.
Participant type
Patient
Age group
Not Specified
Gender
Male
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/10/1994
Recruitment end date
01/02/1999
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Health Promotion Sciences Unit
London
WC1E 7HT
United Kingdom
Sponsor information
Organisation
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Primary and Secondary Care Interface National Research and Development Programme (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list