Condition category
Not Applicable
Date applied
04/01/2007
Date assigned
28/02/2007
Last edited
03/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andrew Oxman

ORCID ID

Contact details

Norwegian Knowledge Centre for the Health Services
P.O. Box 7004
St Olavs Plass
Oslo
0130
Norway

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

http://www.forskningsradet.no

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

Publication citations

Additional files

Editorial Notes