Improving Public Awareness of Clinical Trials through Online Questionnaires: the IMPACT online study

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12613001337763
• Date of registration: 06/12/2013
• Prospective Registration: Yes
• Primary sponsor: University of Sydney
• Public title: Improving Public Awareness of Clinical Trials through Online Questionnaires: the IMPACT online study
• Scientific title: Improving Public Awareness of Clinical Trials through Online Questionnaires: the IMPACT online study
• Date of first enrolment: 19/12/2013
• Target sample size: 300
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12613001337763.aspx
• Study type: Interventional
• Study design: Purpose: Educational / counselling / training; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Factorial;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia, Ireland, Jamaica, New Zealand, South Africa, United Kingdom, United States of America

Contacts

• Name: Prof William Tarnow-Mordi

• Name: Mrs Melinda Cruz

Key inclusion & exclusion criteria

Inclusion criteria: Agreement to complete anonymous online questionnaire
Reported age 18 years or older
Parents
Exclusion criteria: Non agreement to complete anonymous online questionnaire
Reported age less than 18 years

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Public Health - Health promotion/education

Understanding of clinical trials;Anxiety about clinical trials;Willingness to participate in clinical trials;
Understanding of clinical trials
Anxiety about clinical trials
Willingness to participate in clinical trials

Intervention(s)

The study in split into two components: Survey A and B. Respondents who agree to participate will be randomly assigned to either Survey A or B, and undergo one survey only. The study will be administered online. In Survey A, respondents will be randomly assigned to read one of 12 (2x3x2) variations of a leaflet describing a hypothetical trial. These variations incorporate positive, negative or neutral wording. The leaflet is based on BOOST II (www.nejm.org/doi/full/10.1056/NEJMoa1302298). In Survey B, respondents will be randomly presented either (i) a video describing features of clinical trials (ii) a written transcript of the video or (iii) no information. The approximate duration of the video is 5 minutes.

Primary Outcome(s)

For Survey A, the primary outcome being observed is the parent's level of understanding. This will be measured using a previously validated questionnaire (Porteri et al, 2009) adapted for use in parents of newborn infants.[During completion of the anonymous online survey]

For Survey B, respondents’ level of understanding will be measured on a three part Likert Scale on the key aspects and common pitfalls of randomized clinical trials. [During completion of the anonymous online survey]

Secondary Outcome(s)

Both Survey A and B measure general anxiety and changes in levels of anxiety after receiving the intervention. For Survey A this is one of 12 variations of the BOOST II leaflet; and for Survey B this is either the video or the transcript of the ECRAN Video Introduction to Clinical Trials or the control, summing to 3 variations.

Anxiety will be measured using the previously validated State-Trait Anxiety Inventory Form Y (Spielberger et al, 1977; O’Brien et al, 2013). [During completion of the anonymous online survey]

The secondary outcome for both Survey A and B, parents’ willingness to participate, will be measured on a five part Likert Scale ranging from very unlikely to very likely to participate.[During completion of the anonymous online survey]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

NHMRC Clinical Trials Centre, University of Sydney

Secondary Sponsor(s)

Miracle Babies Foundation

Ethics review

Status: Not approved
Approval date:
Contact:

University of Sydney Human Research Ethics Committee 1