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

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.

Study Overview

• Status: Completed
• 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
• Intervention / Treatment: Other: Leaflet; Other: Brochure; Other: Booklet

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 Type: Interventional
• Enrollment (Actual): 428
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Copenhagen Trial Unit, Centre for clinical intervention research
  • Hvidovre, Denmark, 2650
    • Hvidovre University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Copenhagen Trial Unit, Center for Clinical Intervention Research
• Collaborators: The Info Trial Group; Charlotte Behnke; Pia Caspersen; Dorte Fischer; Rolf I. Hansen; Karin Jensen; Birthe Klarskov; Lars K. Møller; Kirsten Obel; Sten N. Rasmussen; Pia Munkholm; Ju-ri Rumessen; Stig Sonne-Holm
• Investigators: Principal Investigator: Kim Krogsgaard, MD, Copenhagen Trial Unit - Centre for Intervention Research, Denmark

Publications and helpful links

General Publications

• Kruse AY, Kjaergard LL, Krogsgaard K, Gluud C, Mortensen EL, Gottschau A, Bjerg AM. A randomized trial assessing the impact of written information on outpatients' knowledge about and attitude toward randomized clinical trials. The INFO trial group. Control Clin Trials. 2000 Jun;21(3):223-40. doi: 10.1016/s0197-2456(00)00048-9.
• Kjaergaard LL, Kruse AY, Krogsgaard K, Gluud CN, Mortensen EL, Gottschau A, Bjerg AM. Outpatients' knowledge about and attitude towards clinical research and randomized clinical trials. The INFO Trial Group. Dan Med Bull. 1998 Sep;45(4):439-43.

Study record dates

Study Major Dates

• Study Start: October 1, 1996
• Primary Completion (Actual): December 1, 1996
• Study Completion (Actual): December 1, 1996

Study Registration Dates

• First Submitted: August 25, 2016
• First Submitted That Met QC Criteria: March 23, 2017
• First Posted (Actual): March 29, 2017

Study Record Updates

• Last Update Posted (Actual): March 29, 2017
• Last Update Submitted That Met QC Criteria: March 23, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: Protokol: 1996-10-31/KK.df; 1996-DP-18-RKF-3-INFO-I (Other Identifier: CTU)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan for data sharing