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Outpatients' Knowledge About and Attitude Toward Randomised Clinical Trials (INFO-I)

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ClinicalTrials.gov Identifier: NCT03094598
Recruitment Status : Completed
First Posted : March 29, 2017
Last Update Posted : March 29, 2017
Sponsor:
Collaborators:
The Info Trial Group
Charlotte Behnke
Pia Caspersen
Dorte Fischer
Rolf I. Hansen
Karin Jensen
Birthe Klarskov
Lars K. Møller
Kirsten Obel
Sten N. Rasmussen
Pia Munkholm
Ju-ri Rumessen
Stig Sonne-Holm
Information provided by (Responsible Party):
Copenhagen Trial Unit, Center for Clinical Intervention Research

Brief Summary:
The purpose of this study is to investigate the knowledge about randomised clinical trials and the attitude towards clinical research among Danish outpatients. The INFO Trial was designed as a randomised, parallel group, observer-blinded trial comparing three types of written information (a leaflet, a brochure, and a booklet) to each other and to a no intervention group.

Condition or disease Intervention/treatment Phase
Ambulatory Patients in the Dep. of Medical Gastroenterology Ambulatory Patients in the Dep. of Gynecology Ambulatory Patients in the Dep. of Orthopedic Surgery Ambulatory Patients in the Dep. of Urology Other: Leaflet Other: Brochure Other: Booklet Not Applicable

Detailed Description:

To improve the patient education process in clinical research, three information materials describing general aspects of design and conduct of randomised clinical trials were developed. The materials varied in length, reading ability level, and reader appeal. Their influence on knowledge about and attitude toward randomised clinical trials was assessed in a randomised, parallel group, evaluator-blinded trial among 415 outpatients recruited from four departments at a university hospital in Copenhagen. The patients were randomised to the following groups: control (no intervention), leaflet, brochure, or booklet in a 1:1:1:1 ratio. Knowledge (KN) was assessed by a 17-item multiple-choice questionnaire and attitude (AT) was assessed by a 32-item Likert questionnaire at entry and 2 weeks after the intervention. The interventions and the questionnaires were pilot tested and power calculations were performed.

Assessment of scales for knowledge and attitudes was performed using Rasch analysis and Cronbach 's alpha. Associations between demographic variables, knowledge score and attitude score were examined using analysis of variance.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 428 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The INFO-I Trial: A Randomised Trial Assessing the Impact of Written Information on Outpatients' Knowledge About and Attitude Toward Randomised Clinical Trials
Study Start Date : October 1996
Actual Primary Completion Date : December 1996
Actual Study Completion Date : December 1996

Arm Intervention/treatment
No Intervention: Control
No intervention
Experimental: Leaflet
The leaflet is based on information and journalism theories, paying attention primarily to reader appeal and readability.
Other: Leaflet
The length is 1.5 A4 pages, Flesch's Reading Ease Score (RES) is 57 (fairly difficult, comparable to a quality magazine), and Human Interest Score (HIS) is 37 (interesting, comparable to a digest magazine).

Experimental: Brochure
The brochure is based on practical communication experience, focusing primarily on logical composition and presentation of condensed information.
Other: Brochure
The length is 2.5 A4 pages, RES is 43 (difficult, comparable to an academic magazine), and HIS is 25 (interesting, comparable to a digest magazine).

Experimental: Booklet
The booklet is also based on practical communication experience, but give more elaborate explanations.
Other: Booklet
The length is 12 A4 pages, RES is 11 (very difficult, comparable to a scientific magazine), and HIS is 22 (mildly interesting, comparable to a trade magazine).




Primary Outcome Measures :
  1. Knowledge (KN) scores [ Time Frame: 2 weeks ]
    Change in knowledge (KN) scores scores between entry and follow-up.


Secondary Outcome Measures :
  1. Attitude (AT) (total) scores [ Time Frame: 2 weeks ]
    Change in attitude (AT) (total) scores between entry and follow-up.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Outpatient
  • Ability to read and understand Danish and written informed consent.

Exclusion Criteria:

  • Patients under 18 years of age and patients enrolled in another clinical trial on the same day.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03094598


Locations
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Denmark
Copenhagen Trial Unit, Centre for clinical intervention research
Copenhagen, Denmark
Hvidovre University Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Copenhagen Trial Unit, Center for Clinical Intervention Research
The Info Trial Group
Charlotte Behnke
Pia Caspersen
Dorte Fischer
Rolf I. Hansen
Karin Jensen
Birthe Klarskov
Lars K. Møller
Kirsten Obel
Sten N. Rasmussen
Pia Munkholm
Ju-ri Rumessen
Stig Sonne-Holm
Investigators
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Principal Investigator: Kim Krogsgaard, MD Copenhagen Trial Unit - Centre for Intervention Research, Denmark
Publications of Results:
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Responsible Party: Copenhagen Trial Unit, Center for Clinical Intervention Research
ClinicalTrials.gov Identifier: NCT03094598    
Other Study ID Numbers: Protokol: 1996-10-31/KK.df
1996-DP-18-RKF-3-INFO-I ( Other Identifier: CTU )
First Posted: March 29, 2017    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan for data sharing