Healthy CohortNCT01978522
The NICOLA Questionnaire Trial (NICOLA-QT)
A study testing Randomisation of questionnaire receipt. in people with Healthy Cohort, run by Queen's University, Belfast at 1 site in United Kingdom.
Trial summary
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… 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?
- Randomisation of questionnaire receipt.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,500 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 Questionnaire Trial (NICOLA-QT): Effect of Timing and Mode of Delivery on Completion and Completeness of a Self-assessment Questionnaire in a Longitudinal Study in People Over Age of 50.
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
Read the detailed 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. In this randomised trial, we will assess the effect of given them the self-assessment questionnaire at different time points, and on paper or online.
Cohort and other studies with longitudinal designs often struggle to maintain their recruited participants across all the study time points and to obtain complete data. The problems reduce the effective sample size quality of the evidence and robustness of the findings, and can undermine the often substantial investment in such studies. Researchers are devoting increasing amounts of time and resources to understand how participants decide to take part in research and what researchers can do to make their work appeal to potential participants. We will explore some of these issues within NICOLA and, to our knowledge, no similar work has been conducted solely within an over 50 population.
Establishing rapport with the participants has been mentioned as another method to increase response rate and we will explore this by examining whether receiving a questionnaire in a face-to-face exchange increases the likelihood of completion - a topic that was not addressed in the aforementioned systematic review.
Our randomised comparison of online versus paper questionnaires will gauge the interest in online methods among the over 50s, and the effects of the different modes on completion and completeness. Embedding this research at the beginning of a large cohort study allows the opportunity to test different methodologies to discover what works best at with regards to the delivery of questionnaires
The overall aim of this research is to examine the impact of differing times and formats of a self assessment questionnaire on completion rates. Specific objectives include:
- Assessing the effect of being given a questionnaire during a face to face interview with a researcher compared to receiving it by post
- Exploring the potential impact of interview fatigue on completion rates
The proposed study is a randomised trial of different timings and methods of offering a self-completion questionnaire. It will be embedded in an ongoing cohort study. All participants who complete the CAPI (Computer Assisted Personal Interview) will be invited to fill in a self-completion (paper) questionnaire whose contents will include measures of: participation in social activities, including organised structured and informal activities; relationship quality (partners/relatives/friends); loneliness; perceived stress; resilience; quality of life; alcohol intake and a measure of food poverty.
After participants have agreed to take part in the study, they will be randomised into one of two different trial arms:
- Receive a paper based questionnaire immediately after their CAPI, handed to them by their Interviewer
- Receive a paper based questionnaire in the post approximately one week after their CAPI interview
- Conditions
- Healthy Cohort
- Being tested
- Randomisation of questionnaire receipt.
- Keywords
- Randomised trial, postal questionnaires, return rates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Randomisation of questionnaire receipt.Other
- The self-completion questionnaire will be delivered to the participants via post a week after completing the CAPI.
- Self-completion questionnaire handed to participants immediately after completing the CAPI.
| Study group | Role | What they receive |
|---|---|---|
| NICOLA Participants | Experimental | All participants enrolled in the NICOLA cohort Receives: Other: Randomisation of questionnaire receipt. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of group on questionnaire return rates
Measured: Within two months
Secondary outcomes (2)
Influence of group on questionnaire completeness
Measured: Within two months
Influence of group on time taken to return questionnaire
Measured: Within two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 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
- 8,500 participants (estimated)
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
- NCT01978522
- Sponsor's protocol ID
- QUB-1112-QT
- Status last verified
- Apr 2018
- First submitted
- 31 Oct 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 Questionnaire Trial (NICOLA-QT): Effect of Timing and Mode of Delivery on Completion and Completeness of a Self-assessment Questionnaire in a Longitudinal Study in People Over Age of 50.
- ClinicalTrials.gov ID
- NCT01978522
- Acronym / sponsor ID
- QUB-1112-QT
- Conditions
- Healthy Cohort
- Keywords
- Randomised trial, postal questionnaires, return rates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,500 participants (estimated)
- 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
- 7 Nov 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.
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
Detailed 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. In this randomised trial, we will assess the effect of given them the self-assessment questionnaire at different time points, and on paper or online.
Cohort and other studies with longitudinal designs often struggle to maintain their recruited participants across all the study time points and to obtain complete data. The problems reduce the effective sample size quality of the evidence and robustness of the findings, and can undermine the often substantial investment in such studies. Researchers are devoting increasing amounts of time and resources to understand how participants decide to take part in research and what researchers can do to make their work appeal to potential participants. We will explore some of these issues within NICOLA and, to our knowledge, no similar work has been conducted solely within an over 50 population.
Establishing rapport with the participants has been mentioned as another method to increase response rate and we will explore this by examining whether receiving a questionnaire in a face-to-face exchange increases the likelihood of completion - a topic that was not addressed in the aforementioned systematic review.
Our randomised comparison of online versus paper questionnaires will gauge the interest in online methods among the over 50s, and the effects of the different modes on completion and completeness. Embedding this research at the beginning of a large cohort study allows the opportunity to test different methodologies to discover what works best at with regards to the delivery of questionnaires
The overall aim of this research is to examine the impact of differing times and formats of a self assessment questionnaire on completion rates. Specific objectives include:
- Assessing the effect of being given a questionnaire during a face to face interview with a researcher compared to receiving it by post
- Exploring the potential impact of interview fatigue on completion rates
The proposed study is a randomised trial of different timings and methods of offering a self-completion questionnaire. It will be embedded in an ongoing cohort study. All participants who complete the CAPI (Computer Assisted Personal Interview) will be invited to fill in a self-completion (paper) questionnaire whose contents will include measures of: participation in social activities, including organised structured and informal activities; relationship quality (partners/relatives/friends); loneliness; perceived stress; resilience; quality of life; alcohol intake and a measure of food poverty.
After participants have agreed to take part in the study, they will be randomised into one of two different trial arms:
- Receive a paper based questionnaire immediately after their CAPI, handed to them by their Interviewer
- Receive a paper based questionnaire in the post approximately one week after their CAPI interview
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NICOLA Participants | Experimental | Other: Randomisation of questionnaire receipt.All participants enrolled in the NICOLA cohort |
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 |
|---|---|---|
| Randomisation of questionnaire receipt.1. The self-completion questionnaire will be delivered to the participants via post a week after completing the CAPI. 2. Self-completion questionnaire handed to participants immediately after completing the CAPI. | Other | NICOLA Participants |
Primary outcome
Influence of group on questionnaire return rates
Time frame: Within two months
2 secondary outcomes
Influence of group on questionnaire completeness
Time frame: Within two months
Influence of group on time taken to return questionnaire
Time frame: Within two 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 Randomisation of questionnaire receipt. 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 group on questionnaire return rates (time frame: Within two months). 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.