NCT03094598

Brief Summary

The purpose of this study is to investigate the knowledge about randomised clinical trials and the attitude towards clinical research among Danish outpatients. The INFO Trial was designed as a randomised, parallel group, observer-blinded trial comparing three types of written information (a leaflet, a brochure, and a booklet) to each other and to a no intervention group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
428

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 1996

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1996

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 1996

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 1996

Completed
19.7 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2016

Completed
7 months until next milestone

First Posted

Study publicly available on registry

March 29, 2017

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2017

Enrollment Period

2 months

First QC Date

August 25, 2016

Last Update Submit

March 23, 2017

Conditions

Ambulatory Patients in the Dep. of Medical GastroenterologyAmbulatory Patients in the Dep. of GynecologyAmbulatory Patients in the Dep. of Orthopedic SurgeryAmbulatory Patients in the Dep. of Urology

Outcome Measures

Primary Outcomes (1)

  • Knowledge (KN) scores

    Change in knowledge (KN) scores scores between entry and follow-up.

    2 weeks

Secondary Outcomes (1)

  • Attitude (AT) (total) scores

    2 weeks

Study Arms (4)

Control

NO INTERVENTION

No intervention

Leaflet

EXPERIMENTAL

The leaflet is based on information and journalism theories, paying attention primarily to reader appeal and readability.

Other: Leaflet

Brochure

EXPERIMENTAL

The brochure is based on practical communication experience, focusing primarily on logical composition and presentation of condensed information.

Other: Brochure

Booklet

EXPERIMENTAL

The booklet is also based on practical communication experience, but give more elaborate explanations.

Other: Booklet

Interventions

LeafletOTHER

The length is 1.5 A4 pages, Flesch's Reading Ease Score (RES) is 57 (fairly difficult, comparable to a quality magazine), and Human Interest Score (HIS) is 37 (interesting, comparable to a digest magazine).

Leaflet
BrochureOTHER

The length is 2.5 A4 pages, RES is 43 (difficult, comparable to an academic magazine), and HIS is 25 (interesting, comparable to a digest magazine).

Brochure
BookletOTHER

The length is 12 A4 pages, RES is 11 (very difficult, comparable to a scientific magazine), and HIS is 22 (mildly interesting, comparable to a trade magazine).

Booklet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Outpatient
  • Ability to read and understand Danish and written informed consent.

You may not qualify if:

  • Patients under 18 years of age and patients enrolled in another clinical trial on the same day.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Copenhagen Trial Unit, Centre for clinical intervention research

Copenhagen, Denmark

Location

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

Related Publications (2)

  • Kruse AY, Kjaergard LL, Krogsgaard K, Gluud C, Mortensen EL, Gottschau A, Bjerg AM. A randomized trial assessing the impact of written information on outpatients' knowledge about and attitude toward randomized clinical trials. The INFO trial group. Control Clin Trials. 2000 Jun;21(3):223-40. doi: 10.1016/s0197-2456(00)00048-9.

    PMID: 10822120RESULT

  • Kjaergaard LL, Kruse AY, Krogsgaard K, Gluud CN, Mortensen EL, Gottschau A, Bjerg AM. Outpatients' knowledge about and attitude towards clinical research and randomized clinical trials. The INFO Trial Group. Dan Med Bull. 1998 Sep;45(4):439-43.

    PMID: 9777295RESULT

Study Officials

  • Kim Krogsgaard, MD

    Copenhagen Trial Unit - Centre for Intervention Research, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2016

First Posted

March 29, 2017

Study Start

October 1, 1996

Primary Completion

December 1, 1996

Study Completion

December 1, 1996

Last Updated

March 29, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

No plan for data sharing

Locations

DK(2)