Outpatients' Knowledge About and Attitude Toward Randomised Clinical Trials (INFO-I)

Copenhagen Trial Unit, Center for Clinical Intervention Research

Status: Completed

Conditions: Ambulatory Patients in the Dep. of Orthopedic Surgery; Ambulatory Patients in the Dep. of Urology; Ambulatory Patients in the Dep. of Gynecology; Ambulatory Patients in the Dep. of Medical Gastroenterology

Treatments: Other: Booklet; Other: Brochure; Other: Leaflet

Study type: Interventional

Funder types: Other

Identifiers

NCT03094598

Protokol: 1996-10-31/KK.df

1996-DP-18-RKF-3-INFO-I (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 428 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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428 participants in 4 patient groups

Control

No Intervention group

Description:

No intervention

Leaflet

Experimental group

Description:

The leaflet is based on information and journalism theories, paying attention primarily to reader appeal and readability.

Treatment:

Other: Leaflet

Brochure

Experimental group

Description:

The brochure is based on practical communication experience, focusing primarily on logical composition and presentation of condensed information.

Treatment:

Other: Brochure

Booklet

Experimental group

Description:

The booklet is also based on practical communication experience, but give more elaborate explanations.

Treatment:

Other: Booklet