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

NCT03094585 | Completed

• 2 other identifiers: Protocol: 1996-10-31/KK.df1997-DP-31-RKF-5-INFO-II [CTU]
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy

Keywords

Healthy nurses

Outcome Measures

Primary Outcomes (1)

• Knowledge score (questionnaire)

  The primary outcome is obtaining satisfactory knowledge score by using a Knowledge questionnaire.

  Two weeks

Secondary Outcomes (1)

• Attitude towards clinical research and randomized clinical trials (questionnaire)

  Two weeks

Study Arms (3)

No information

NO INTERVENTION

The nurses in this group are offered no booklet or oral information

Written and oral information

EXPERIMENTAL

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

Written information

EXPERIMENTAL

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

Interventions

Written and oral information OTHER

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 and oral information

Written information OTHER

The written information (booklet) was 12 A4 pages long and took about 15 minutes to read.

Written information

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Graduated nurse
• Signed informed consent

You may not qualify if:

• Participant in another trial similar to the present trial

Sponsors & Collaborators

• Copenhagen Trial Unit, Center for Clinical Intervention Research: lead
• Section for Health Services Research, Department of Public Health, Copenhagen University Hospital: collaborator
• Hvidovre University Hospital: collaborator

Study Sites (2)

Copenhagen Trial Unit, Centre for clinical intervention research

Coepnhagen, 2200, Denmark

Location

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

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: September 1, 1997
• Primary Completion: September 1, 1997
• Last Updated: March 29, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)