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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Other: Written and oral information
* Other: Written information


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Graduated nurse Signed informed consent Exclusion Criteria: Participant in another trial similar to the present trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy nurses