The NICOLA Recruitment Trial (NICOLA-RT) (NICOLA-RT)

April 10, 2018 updated by: Lisa Maguire, Queen's University, Belfast

The NICOLA Recruitment Trial (NICOLA-RT): the Effect of Invitation Letters on Overall Recruitment in a Longitudinal Cohort Study in People Over Age of 50.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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 links 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 invitation letters offered to participants on study recruitment rates, with the following specific objectives:

  • Understanding if the gender of the person signing the invitation letter has an effect on recruitment
  • Exploring the potential impact of the use of describing the research as a 'study' or as a 'project'
  • Understanding if discussing and guaranteeing confidentiality for the participants in the invitation letter has an impact on recruitment.

We will do this by randomly allocating each of the 13000 participants contacted by NICOLA to receive invitation letter by one of the following three choices using a 3x2x2 factorial design:

  1. Gender of the signatory (male versus female versus neutral team signature)
  2. Description of NICOLA (study versus project)
  3. Guarantee of confidentiality (inserted versus removed)

We will then analyse the numbers of participants agreeing to join NICOLA and use this to determine which invitation letter is the most acceptable to the participants. This research will occur within the first 18 months of NICOLA, when all participants are being recruited.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom, BT12 6BJ
        • Lisa Maguire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants must be aged 50 or over.
  • Participants must be living in an non-institutionalised environment.
  • Participants must be capable of providing informed consent.

Exclusion Criteria:

  • Participants who are 49 or younger.
  • Participants who are institutionalised.
  • Participants who are not capable of providing informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Potential NICOLA Participants
All potential participants identified through the sampling strategy and contacted to take part in the NICOLA study
Other: Invitation letter randomisation

There are 12 versions of the invitation letter. Three aspects of the letter will be adapted: (1) Gender of the signatory i.e. male, female or gender neutral (signed from the NICOLA team) (2) Description of NICOLA as a 'study' or 'project' and (3) Inserting a sentence guaranteeing the participants confidentially or not having this in the letter (but will still appear in the Patient Information Sheet). The twelve versions are as follows:

  1. Male & Study & Confidentiality
  2. Male & Study
  3. Male & Project & Confidentiality
  4. Male & Project
  5. Female & Project & Confidentiality
  6. Female & Project
  7. Female & Study & Confidentiality
  8. Female & Study
  9. Neutral & Study & Confidentiality
  10. Neutral & Study
  11. Neutral & Project & Confidentiality
  12. Neutral & Project

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Influence of invitation letter on participation rates.
Time Frame: Average two weeks
Difference in participation rates in those receiving letters (1) through to (12)
Average two weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Influence of invitation letter on study retention
Time Frame: Average twelve months
Assessing the retention in the first year of the study including: completion of interview; return of self-completion questionnaire and participation in the health assessment.
Average twelve months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Queen's University, Belfast

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mike Clarke, PhD, Queen's University, Belfast

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 11, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 12/23

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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