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
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||428 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
No Intervention: Control
The leaflet is based on information and journalism theories, paying attention primarily to reader appeal and readability.
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).
The brochure is based on practical communication experience, focusing primarily on logical composition and presentation of condensed information.
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).
The booklet is also based on practical communication experience, but give more elaborate explanations.
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).
- Knowledge (KN) scores [ Time Frame: 2 weeks ]Change in knowledge (KN) scores scores between entry and follow-up.
- Attitude (AT) (total) scores [ Time Frame: 2 weeks ]Change in attitude (AT) (total) scores between entry and follow-up.
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
|Copenhagen Trial Unit, Centre for clinical intervention research|
|Hvidovre University Hospital|
|Hvidovre, Denmark, 2650|
|Principal Investigator:||Kim Krogsgaard, MD||Copenhagen Trial Unit - Centre for Intervention Research, Denmark|