Healthy CohortNICOLA-RTNCT01938898
The NICOLA Recruitment Trial (NICOLA-RT)
A study testing Invitation letter randomisation in people with Healthy Cohort, run by Queen's University, Belfast at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Cohort
- What is being tested?
- Invitation letter randomisation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2014to 20 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be aged 50 or over.
- Participants must be living in an non-institutionalised environment.
- Participants must be capable of providing informed consent.
Who cannot join
- Participants who are 49 or younger.
- Participants who are institutionalised.
- Participants who are not capable of providing informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- Gender of the signatory (male versus female versus neutral team signature)
- Description of NICOLA (study versus project)
- 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.
- Conditions
- Healthy Cohort
- Being tested
- Invitation letter randomisation
- Keywords
- Randomized trial, Invitation letter, Recruitment, Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invitation letter randomisationOther
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:
- Male \& Study \& Confidentiality
- Male \& Study
- Male \& Project \& Confidentiality
- Male \& Project
- Female \& Project \& Confidentiality
- Female \& Project
- Female \& Study \& Confidentiality
- Female \& Study
- Neutral \& Study \& Confidentiality
- Neutral \& Study
- Neutral \& Project \& Confidentiality
- Neutral \& Project
| Study group | Role | What they receive |
|---|---|---|
| Potential NICOLA Participants | Other | All potential participants identified through the sampling strategy and contacted to take part in the NICOLA study Receives: Other: Invitation letter randomisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of invitation letter on participation rates.
Difference in participation rates in those receiving letters (1) through to (12)
Measured: Average two weeks
Secondary outcomes (1)
Influence of invitation letter on study retention
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.
Measured: Average twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study start1 Jan 2014
- Primary completion20 Dec 2015
- Study completion20 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy CohortStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 13,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Maguire, Queen's University, Belfast
- Investigators
- Mike Clarke, PhD, Principal investigator, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01938898
- Sponsor's protocol ID
- 12/23
- Acronym
- NICOLA-RT
- Status last verified
- Apr 2018
- First submitted
- 5 Sep 2013
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT01938898
- Acronym / sponsor ID
- NICOLA-RT / 12/23
- Conditions
- Healthy Cohort
- Keywords
- Randomized trial, Invitation letter, Recruitment, Retention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13,000 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 20 Dec 2015 (actual)
- Study completion
- 20 Dec 2016 (actual)
- First posted
- 10 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Gender of the signatory (male versus female versus neutral team signature)
- Description of NICOLA (study versus project)
- 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Potential NICOLA Participants | Other | Other: Invitation letter randomisationAll potential participants identified through the sampling strategy and contacted to take part in the NICOLA study |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must be aged 50 or over.
- Participants must be living in an non-institutionalised environment.
- Participants must be capable of providing informed consent.
Key exclusion criteria (3 listed)
- Participants who are 49 or younger.
- Participants who are institutionalised.
- Participants who are not capable of providing informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invitation letter randomisationThere 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 | Other | Potential NICOLA Participants |
Primary outcome
Influence of invitation letter on participation rates.
Time frame: Average two weeks
Difference in participation rates in those receiving letters (1) through to (12)
1 secondary outcome
Influence of invitation letter on study retention
Time frame: Average twelve months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mike Clarke, PhD principal investigator
Queen's University, Belfast
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Invitation letter randomisation in people with Healthy Cohort, run by Queen's University, Belfast at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influence of invitation letter on participation rates. (time frame: Average two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2018.