Outpatients' Knowledge About and Attitude Toward Randomised Clinical Trials

Ambulatory Patients in the Dep. of Gynecology Clinical Trial

— INFO-I  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03094598
• Other study ID #: Protokol: 1996-10-31/KK.df
• Secondary ID: 1996-DP-18-RKF-3
• Status: Completed
• Phase: N/A
• First received: August 25, 2016
• Last updated: March 23, 2017
• Start date: October 1996
• Est. completion date: December 1996

Study information

• Verified date: March 2017
• Source: Copenhagen Trial Unit, Center for Clinical Intervention Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 428
• Est. completion date: December 1996
• Est. primary completion date: December 1996
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• 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

Intervention

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).
• 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).
• 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).

Locations

Country	Name	City	State
Denmark	Copenhagen Trial Unit, Centre for clinical intervention research	Copenhagen
Denmark	Hvidovre University Hospital	Hvidovre

Sponsors (14)

Lead Sponsor	Collaborator
Copenhagen Trial Unit, Center for Clinical Intervention Research	Birthe Klarskov, Charlotte Behnke, Dorte Fischer, Ju-ri Rumessen, Karin Jensen, Kirsten Obel, Lars K. Møller, Pia Caspersen, Pia Munkholm, Rolf I. Hansen, Sten N. Rasmussen, Stig Sonne-Holm, The INFO Trial Group

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

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. — View Citation

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. Contro — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knowledge (KN) scores	Change in knowledge (KN) scores scores between entry and follow-up.	2 weeks
Secondary	Attitude (AT) (total) scores	Change in attitude (AT) (total) scores between entry and follow-up.	2 weeks