Outpatients' Knowledge About and Attitude Toward Randomised Clinical Trials

Not Applicable

Completed

• Conditions: Ambulatory Patients in the Dep. of Gynecology; Ambulatory Patients in the Dep. of Medical Gastroenterology; Ambulatory Patients in the Dep. of Orthopedic Surgery; Ambulatory Patients in the Dep. of Urology
• Interventions: Other: Leaflet; Other: Brochure; Other: Booklet

• Registration Number: NCT03094598
• Lead Sponsor: Copenhagen Trial Unit, Center for Clinical Intervention Research

Brief 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.

Study Timeline

• Study Start: 1996-10
• Primary Completion: 1996-12
• Study Completion: 1996-12
• Study First Submitted: 2016-08-25
• Status Verified: 2017-03
• Study First Submitted QC: 2017-03-23
• Last Update Submitted: 2017-03-23
• Study First Posted: 2017-03-29
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 428

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Leaflet	Leaflet	The leaflet is based on information and journalism theories, paying attention primarily to reader appeal and readability.
Brochure	Brochure	The brochure is based on practical communication experience, focusing primarily on logical composition and presentation of condensed information.
Booklet	Booklet	The booklet is also based on practical communication experience, but give more elaborate explanations.

Primary Outcome Measures

Name	Time	Method
Knowledge (KN) scores	2 weeks	Change in knowledge (KN) scores scores between entry and follow-up.

Secondary Outcome Measures

Name	Time	Method
Attitude (AT) (total) scores	2 weeks	Change in attitude (AT) (total) scores between entry and follow-up.

Trial Locations

Locations (2)

Copenhagen Trial Unit, Centre for clinical intervention research; 🇩🇰 Copenhagen, Denmark

Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark