NCT01938898: NICOLA-RT

The NICOLA Recruitment Trial (NICOLA-RT)

Completed NA Last updated 11 April 2018

What this trial tests

NA trial testing Invitation letter randomisation in Healthy Cohort in 13,000 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	13,000
Start date	1 January 2014
Primary completion	20 December 2015
Estimated completion	20 December 2016
Sites	1 location across United Kingdom

Drugs / interventions tested

• Invitation letter randomisation

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

The Northern Ireland Cohort for the Longitudinal Study of Ageing (NICOLA) is an opportunity to conduct methodology research relevant to many features of a large prospective study. NICOLA will begin in earnest in Northern Ireland in 2013 and is being conducted by a multidisciplinary team in the Centre for Public Health at Queen's University Belfast. It is an omnibus programme of research on ageing that will continue for at least 10 years and will recruit 8500 middle-aged people in Northern Ireland and follow them into old age, providing a comprehensive assessment of their physical and mental health, their lifestyles, and their social and economic decision making. NICOLA will look at how they perceive disability and health, and how this differs between well-off and disadvantaged groups. NICOLA will also study various genetic, biological and psychological factors, including how participants perceive risk and value their time, and the effect of this on their retirement behaviour (including how they manage their money and their health). People over the age of 50 will be invited to take part and asked to complete detailed interviews and questionnaires every 2 years and health assessments every 4 years.

The overall aim of this research is to examine the impact of differing invitation letters offered to participants on study recruitment rates.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Dietary patterns associated with renal impairment in the Northern Ireland Cohort for the Longitudinal Study of Ageing (NICOLA).
   Paterson EN, Neville CE, Wallace SM, Woodside JV, et al · · 2021 · cited 6× · PMID 33959803 · DOI 10.1007/s00394-021-02579-z
2. The NICOLA recruitment trial (NICOLA-RT): can you improve recruitment by making zero cost amendments to the invitation letter?
   Maguire L, Burns F, Clarke M. · · 2015