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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Written and oral information; Other: Written information

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Coepnhagen, Denmark, 2200
    • Copenhagen Trial Unit, Centre for clinical intervention research
  • Hvidovre, Denmark, 2650
    • Hvidovre University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Graduated nurse
• Signed informed consent

Exclusion Criteria:

• Participant in another trial similar to the present trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No information; The nurses in this group are offered no booklet or oral information
Experimental: 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	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.
Experimental: 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.	Other: Written information; The written information (booklet) was 12 A4 pages long and took about 15 minutes to read.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge score (questionnaire)	The primary outcome is obtaining satisfactory knowledge score by using a Knowledge questionnaire.	Two weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Copenhagen Trial Unit, Center for Clinical Intervention Research
• Collaborators: Hvidovre University Hospital; Section for Health Services Research, Department of Public Health, Copenhagen University Hospital
• Investigators: Principal Investigator: Kim Krogsgaard, MD, Copenhagen Trial Unit - Centre for Intervention Research, Denmark

Study record dates

Study Major Dates

• Study Start: September 1, 1997
• Primary Completion (Actual): September 1, 1997

Study Registration Dates

• First Submitted: August 25, 2016
• First Submitted That Met QC Criteria: March 23, 2017
• First Posted (Actual): March 29, 2017

Study Record Updates

• Last Update Posted (Actual): March 29, 2017
• Last Update Submitted That Met QC Criteria: March 23, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Healthy nurses
• Other Study ID Numbers: Protocol: 1996-10-31/KK.df; 1997-DP-31-RKF-5-INFO-II [CTU]

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan for data sharing