Outpatients' Knowledge About and Attitude Toward Randomised Clinical Trials

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The INFO-I Trial: A Randomised Trial Assessing the Impact of Written Information on Outpatients' Knowledge About and Attitude Toward Randomised Clinical Trials

Conditions
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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

Intervention / Treatment
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* Other: Leaflet
* Other: Brochure
* Other: Booklet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>No intervention | |
| Experimental: Leaflet<br>The leaflet is based on information and journalism theories, paying attention primarily to reader appeal and readability. | Other: Leaflet<br>* 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).<br>|
| Experimental: Brochure<br>The brochure is based on practical communication experience, focusing primarily on logical composition and presentation of condensed information. | Other: Brochure<br>* 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).<br>|
| Experimental: Booklet<br>The booklet is also based on practical communication experience, but give more elaborate explanations. | Other: Booklet<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge (KN) scores | Change in knowledge (KN) scores scores between entry and follow-up. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attitude (AT) (total) scores | Change in attitude (AT) (total) scores between entry and follow-up. | 2 weeks |