NCT01978522

The NICOLA Questionnaire Trial (NICOLA-QT)

Completed NA Last updated 11 April 2018

What this trial tests

NA trial testing Randomisation of questionnaire receipt. in Healthy Cohort in 8,500 participants. Completed in 20 December 2016.

Timeline

1 January 2014

Primary endpoint
20 December 2015

20 December 2016

Quick facts

Lead sponsor	Queen's University, Belfast
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	double
Primary purpose	other
Enrollment	8,500
Start date	1 January 2014
Primary completion	20 December 2015
Estimated completion	20 December 2016
Sites	1 location across United Kingdom

Drugs / interventions tested

• Randomisation of questionnaire receipt.

Conditions studied

• Healthy Cohort — all drugs for Healthy Cohort →

Sponsor

Queen's University, Belfast

Who can join

50 and older, any sex, with Healthy Cohort. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Recruiting, retaining and gathering complete data on participants in research projects, be they patients or health professionals, can be extremely difficult. These problems increase the risk that research will be abandoned before its true value is appreciated, or lead to delays in resolving uncertainty for decision makers, while further studies are done. Poor recruitment, retention and outcome collection frequently lead to many prospective studies being extended, increasing costs. Researchers need to use strategies that are themselves evidence-based. This study proposes to link with an existing longitudinal ageing study called NICOLA to provide evidence on what research participants prefer in relation to providing personal information through a self-completed questionnaire. NICOLA is a large study of people over the age of 50 that is being conducted in Northern Ireland. NICOLA is aiming to recruit 8500 people and will ask them questions about participation in social activities, including organised structured and informal activities; relationship quality; loneliness; stress; resilience; quality of life; alcohol intake; food poverty and assess their health and wellbeing. Participants in NICOLA agree to having an interviewer visit them at home to ask questions about their lives, complete questionnaires in their own time and attend a health assessment appointment. They also agree to being followed up over a course of at least 10 years. The research described here will examine the impact of differing times and formats of a self assessment questionnaire on completion rates, specifically:

* To assess the effect of being given a questionnaire during a face to face interview with a researcher compared to receiving it by post
* To explore the potential impact of interview fatigue on completion rates

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The NICOLA questionnaire trial (NICOLA-QT): a randomised trial of the effect of timing and mode of delivery on the completion and return of a self-assessment questionnaire
   Maguire L, Burns F, Clarke M. · · 2015