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

Healthy Clinical Trial

— INFO-II  

Official title:

Nurses Knowledge About and Attitude Towards Clinical Trials. A Randomised Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03094585
• Other study ID #: Protocol: 1996-10-31/KK.df
• Secondary ID: 1997-DP-31-RKF-5
• Status: Completed
• Phase: N/A
• First received: August 25, 2016
• Last updated: March 23, 2017
• Start date: September 1997

Study information

• Verified date: March 2017
• Source: Copenhagen Trial Unit, Center for Clinical Intervention Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: September 1997
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Graduated nurse

• Signed informed consent

Exclusion Criteria:

• Participant in another trial similar to the present trial

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Written and oral information
The written information (booklet) was 12 A4 pages long and took about 15 minutes to read. 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.
• Written information
The written information (booklet) was 12 A4 pages long and took about 15 minutes to read.

Locations

Country	Name	City	State
Denmark	Copenhagen Trial Unit, Centre for clinical intervention research	Coepnhagen
Denmark	Hvidovre University Hospital	Hvidovre

Sponsors (3)

Lead Sponsor	Collaborator
Copenhagen Trial Unit, Center for Clinical Intervention Research	Nursing Department, Hvidovre Hospital, Section for Health Services Research, Department of Public Health, Copenhagen University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knowledge score (questionnaire)	The primary outcome is obtaining satisfactory knowledge score by using a Knowledge questionnaire.	Two weeks
Secondary	Attitude towards clinical research and randomized clinical trials (questionnaire)	Secondary outcome is the attitude towards clinical research and randomized clinical trials. This is obtained by using a attitude questionnaire.	Two weeks

External Links

•   INFO-II unpublished result paper