The INFO-II Trial: Nurses Knowledge About and Attitude Towards Clinical Trials

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Written information; Other: Written and oral information

• Registration Number: NCT03094585
• Lead Sponsor: Copenhagen Trial Unit, Center for Clinical Intervention Research

Brief Summary

The purpose of this study is to examine (a) nurses' knowledge about and attitude towards clinical research, and (b) the effect of written and oral information on nurses' knowledge about and attitude towards clinical research.

Detailed Description

A randomised (1:1:1), evaluator-blinded educational trial on written and oral information versus oral information alone versus no information on nurses' knowledge about and attitude towards clinical research in a university hospital in Copenhagen, Denmark. The investigators planned to randomise 213 nurses (approximately 71 to each intervention group) based on a minimal relevant difference of 1.6 points on the knowledge scale, a standard deviation of 3.1 points, a beta (type II error) risk of 0.20, and an alpha of 0.025. At entry and two weeks later, the nurses should complete two validated questionnaires, which indicated their knowledge on a 0-17 point scale and their attitude on a 0-156 point scale. Predictors of the entry knowledge and attitude and changes in knowledge and attitude after interventions were planned to be identified through adjusted ANOVA. The effects of the active interventions were compared with the control and adjusted for multiple comparisons. Interventions: Written and oral information: The nurses in this group are offered the written information consisted of a booklet which described basic aspects of clinical research including aim, background, formalities, ethics, informed consent, randomisation, blinding, placebo, drug development, and financial aspects. The booklet was developed with the assistance of nurses, physicians, psychologists, researchers, and communication experts. The booklet was adjusted after repeated pilot tests among laymen and employees at our research institution. The booklet was 12 A4 pages long and took about 15 minutes to read. In the INFO I trial, the booklet had a significant effect on outpatients' knowledge about and attitude towards clinical research. The oral information consisted of group sessions which focused on active feedback. Each session was lead by one of the authors who first went through the topics described in the booklet. The review of the topics was followed by a plenary discussion. The sessions lasted 15 to 40 minutes, depending on the interest of the nurses. Written information: The nurses in this group are offered the written information consisted of the same booklet as above, but without oral information. No information: The nurses in this group are offered no booklet or oral information.

Study Timeline

• Study Start: 1997-09
• Primary Completion: 1997-09
• Study First Submitted: 2016-08-25
• Status Verified: 2017-03
• Study First Submitted QC: 2017-03-23
• Last Update Submitted: 2017-03-23
• Study First Posted: 2017-03-29
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Graduated nurse
• Signed informed consent

Exclusion Criteria

• Participant in another trial similar to the present trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Written information	Written information	The nurses in this group are offered written information which consisted of a booklet describing basic aspects of clinical research including aim, background, formalities, ethics, informed consent, randomisation, blinding, placebo, drug development, and financial aspects.
Written and oral information	Written and oral information	The nurses in this group are offered written information which consisted of a booklet describing basic aspects of clinical research including aim, background, formalities, ethics, informed consent, randomisation, blinding, placebo, drug development, and financial aspects. Furthermore, they are offered oral information which consisted of group sessions focusing on active feedback

Primary Outcome Measures

Name	Time	Method
Knowledge score (questionnaire)	Two weeks	The primary outcome is obtaining satisfactory knowledge score by using a Knowledge questionnaire.

Secondary Outcome Measures

Name	Time	Method
Attitude towards clinical research and randomized clinical trials (questionnaire)	Two weeks	Secondary outcome is the attitude towards clinical research and randomized clinical trials. This is obtained by using a attitude questionnaire.

Trial Locations

Locations (2)

Copenhagen Trial Unit, Centre for clinical intervention research; 🇩🇰 Coepnhagen, Denmark

Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark