HealthyINFO-IINCT03094585
The INFO-II Trial: Nurses Knowledge About and Attitude Towards Clinical Trials
A study testing Written and oral information and Written information in people with Healthy, run by Copenhagen Trial Unit, Center for Clinical Intervention Research at 2 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Written and oral information and Written information
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 2 sitesDenmark
- Study dates
- Sep 1997to Sep 1997
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Graduated nurse
- Signed informed consent
Who cannot join
- Participant in another trial similar to the present trial
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Copenhagen Trial Unit, Centre for clinical intervention research
Coepnhagen, 2200
Hvidovre University Hospital
Hvidovre, 2650
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Written and oral information, Written information
- Keywords
- Healthy nurses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Written and oral informationOther
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 informationOther
The written information (booklet) was 12 A4 pages long and took about 15 minutes to read.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Written information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge score (questionnaire)
The primary outcome is obtaining satisfactory knowledge score by using a Knowledge questionnaire.
Measured: Two weeks
Secondary outcomes (1)
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.
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study startSep 1997
- Primary completionSep 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Copenhagen Trial Unit, Center for Clinical Intervention Research
- Sponsor type
- University, hospital or other
- Collaborators
- Section for Health Services Research, Department of Public Health, Copenhagen University Hospital, Hvidovre University Hospital
- Responsible party
- Sponsor
- Investigators
- Kim Krogsgaard, MD, Principal investigator, Copenhagen Trial Unit - Centre for Intervention Research, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094585
- Sponsor's protocol ID
- Protocol: 1996-10-31/KK.df
- Other IDs
- 1997-DP-31-RKF-5-INFO-II [CTU]
- Acronym
- INFO-II
- Status last verified
- Mar 2017
- First submitted
- 25 Aug 2016
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No plan for data sharing
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurses Knowledge About and Attitude Towards Clinical Trials. A Randomised Trial
- ClinicalTrials.gov ID
- NCT03094585
- Acronym / sponsor ID
- INFO-II / Protocol: 1996-10-31/KK.df
- Conditions
- Healthy
- Keywords
- Healthy nurses
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Copenhagen Trial Unit, Center for Clinical Intervention ResearchUniversity, hospital or other
- Collaborators
- Section for Health Services Research, Department of Public Health, Copenhagen University Hospital, Hvidovre University Hospital
- Study start
- Sep 1997
- Primary completion
- Sep 1997 (actual)
- First posted
- 29 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No information | No intervention | –The nurses in this group are offered no booklet or oral information |
| Written and oral information | Experimental | Other: Written and oral informationThe 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 |
| Written information | Experimental | Other: Written informationThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Graduated nurse
- Signed informed consent
Key exclusion criteria (1 listed)
- Participant in another trial similar to the present trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Written and oral informationThe 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. | Other | Written and oral information |
| Written informationThe written information (booklet) was 12 A4 pages long and took about 15 minutes to read. | Other | Written information |
Primary outcome
Knowledge score (questionnaire)
Time frame: Two weeks
The primary outcome is obtaining satisfactory knowledge score by using a Knowledge questionnaire.
1 secondary outcome
Attitude towards clinical research and randomized clinical trials (questionnaire)
Time frame: Two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Individual participant dataSharing planned: No. No plan for data sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim Krogsgaard, MD principal investigator
Copenhagen Trial Unit - Centre for Intervention Research, Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Written and oral information and Written information in people with Healthy, run by Copenhagen Trial Unit, Center for Clinical Intervention Research at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge score (questionnaire) (time frame: Two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.