Ambulatory Patients in the Dep. of Gynecology Clinical Trial
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
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.
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