Clinical trial NCT03094598: Outpatients' Knowledge About and Attitude Toward Randomised Clinical Trials
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Copenhagen Trial Unit, Center for Clinical Intervention Research
Sponsor class: OTHER
Collaborators: name: The Info Trial Group
name: Charlotte Behnke
name: Pia Caspersen
name: Dorte Fischer
name: Rolf I. Hansen
name: Karin Jensen
name: Birthe Klarskov
name: Lars K. Møller
name: Kirsten Obel
name: Sten N. Rasmussen
name: Pia Munkholm
name: Ju-ri Rumessen
name: Stig Sonne-Holm
First posted: 2017-03-29
Enrollment: 428
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Knowledge (KN) scores
timeFrame: 2 weeks
Secondary outcomes:
measure: Attitude (AT) (total) scores
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen Trial Unit, Centre for clinical intervention research
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
affiliation: Copenhagen Trial Unit - Centre for Intervention Research, Denmark
name: Kim Krogsgaard, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. Control Clin Trials. 2000 Jun;21(3):223-40. doi: 10.1016/s0197-2456(00)00048-9.
citation: 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.