Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HIPPO 1
Study information
Scientific title
Acronym
HIPPO pilot
Study hypothesis
Pilot study - development of methodology to:
1. Analyse which of several presentations of evidence of treatment effects best help people to make treatment decisions congruent with their own values
2. Compare visual analogue scales and category rating scales as value elicitation instruments
Ethics approval
This study was approved by the ethics review board at the University at Buffalo on the 15 May 2002 with several renewals.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
N/A
Intervention
Six different summary statistics presenting ten year risk reduction effect of statins on coronary heart disease in the treatment of hypercholesteremia.
The methodological aspects reported in this study include comparison of two value elicitation instruments (visual analogue scales and category rating scales), four theory-grounded approaches to weighting elicited values, and six summary statistics to evaluate the extent to which they promote decisions consistent with elicited values. In addition, we report hypothesis generation and sample size calculation for a randomised controlled trial comparing the same six summary statistics for communicating evidence of reduced risk of coronary heart disease, as well as on the feasibility of conducting this type of Internet-based randomised trial.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Acceptance or rejection of statin treatment
2. Estimated probability to accept or reject statin treatment in relation to value score
Secondary outcome measures
1. To investigate the feasibility of conducting Internet-based randomised trials comparing different risk reduction presentations
2. To compare two methods of eliciting values
3. Four ways of weighting the elicited values to calculate a total value
4. To generate hypotheses and calculate sample size for a confirmatory study comparing six summary statistics for communicating evidence of reduced risk of Coronary Heart Disease (CHD) with statin therapy for treatment of high cholesterol
Overall trial start date
31/10/2002
Overall trial end date
04/12/2002
Reason abandoned
Eligibility
Participant inclusion criteria
1. 18 years old
2. Fluent in English or Norwegian
3. Must give informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
770
Participant exclusion criteria
Not meeting inclusion requirements
Recruitment start date
31/10/2002
Recruitment end date
04/12/2002
Locations
Countries of recruitment
Norway, United States of America
Trial participating centre
Norwegian Knowledge Centre for the Health Services
Oslo
0130
Norway
Sponsor information
Organisation
Norwegian Research Council (Norway)
Sponsor details
P.O. Box 2700
St. Hanshaugen
Oslo
0131
Norway
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Norwegian Research Council (Norway) (project 135210 - A series of randomised trials comparing different ways of presenting health evidence on the Internet)
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
Results - basic reporting
Publication summary