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Completed

NCT Number: NCT03094598

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.

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Key information

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Copenhagen Trial Unit, Centre for clinical intervention research, Copenhagen, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Leaflet

Other

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

Other

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

Other

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).

Primary outcomes

  1. Knowledge (KN) scores

    Time frame: 2 weeks

    Change in knowledge (KN) scores scores between entry and follow-up.

Secondary outcomes

  1. Attitude (AT) (total) scores

    Time frame: 2 weeks

    Change in attitude (AT) (total) scores between entry and follow-up.

Sponsors and collaborators

Lead sponsor

Copenhagen Trial Unit, Center for Clinical Intervention Research

Other

Collaborators

  • 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

Registry information

Official study title

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

Acronym: INFO-I

Important dates

Study start
1996
Primary completion
1996
Study completion
1996
First posted
Mar 29, 2017
Registry last updated
Mar 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.