NCT03094598

Outpatients' Knowledge About and Attitude Toward Randomised Clinical Trials

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 428 (actual)
• Sponsor: Copenhagen Trial Unit, Center for Clinical Intervention Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• 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

Interventions

Type	Name	Description
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).
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).
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).

Timeline

• Start date: 1996-10-01
• Primary completion: 1996-12-01
• Completion: 1996-12-01
• First posted: 2017-03-29
• Last updated: 2017-03-29

Locations

2 sites across 1 country: Denmark