An interventional study of Leaflet and Brochure in Ambulatory Patients in the Dep. of Medical Gastroenterology, Ambulatory Patients in the Dep. of Gynecology and Ambulatory Patients in the Dep. of Orthopedic Surgery, sponsored by Copenhagen Trial Unit, Center for Clinical Intervention Research. Completed at 2 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-29.
Sponsored by Copenhagen Trial Unit, Center for Clinical Intervention Research · Not applicable, Interventional, and Other
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.
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.
Copenhagen Trial Unit, Center for Clinical Intervention Research is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
No intervention
The leaflet is based on information and journalism theories, paying attention primarily to reader appeal and readability.
Other: Leaflet
The brochure is based on practical communication experience, focusing primarily on logical composition and presentation of condensed information.
Other: Brochure
The booklet is also based on practical communication experience, but give more elaborate explanations.
Other: Booklet
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 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 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
Change in knowledge (KN) scores scores between entry and follow-up.
Time frame: 2 weeks
Attitude (AT) (total) scores
Change in attitude (AT) (total) scores between entry and follow-up.
Time frame: 2 weeks
Plan to share: No — No plan for data sharing
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Copenhagen Trial Unit, Center for Clinical Intervention Research