- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01978522
The NICOLA Questionnaire Trial (NICOLA-QT)
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Northern Ireland
-
Belfast, Northern Ireland, United Kingdom, BT12 6BJ
- Lisa Maguire
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
Intervention / Treatment |
---|---|
Experimental: NICOLA Participants
All participants enrolled in the NICOLA cohort
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Influence of group on questionnaire return rates
Time Frame: Within two months
|
Within two months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Influence of group on questionnaire completeness
Time Frame: Within two months
|
Within two months
|
Influence of group on time taken to return questionnaire
Time Frame: Within two months
|
Within two months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mike Clarke, PhD, Queen's University, Belfast
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- QUB-1112-QT
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.
Clinical Trials on Healthy Cohort
-
Queen's University, BelfastCompleted
-
Queen's University, BelfastGlasgow Caledonian University; University of GlasgowCompleted
-
Institut National de la Santé Et de la Recherche...University Hospital, Montpellier; University Hospital, Grenoble; APHP; CHU LYON; ...Recruiting
-
Rebiscan, Inc.BlueGrass Orthopaedics Surgery & Hand CareCompletedWave Form Signals Coming From the Eye in a Healthy CohortUnited States
-
Qilu Hospital of Shandong UniversityRecruiting
-
Chang Gung Memorial HospitalRecruiting
-
Ya-Wei XuCompletedLeft Ventricular Diastoic Dysfunction Cohort Study
-
VA Office of Research and DevelopmentActive, not recruiting
-
Peking University First HospitalRecruiting
-
Chinese PLA General HospitalPeking University First Hospital; Xiangya Hospital of Central South University and other collaboratorsCompleted
Clinical Trials on Randomisation of questionnaire receipt.
-
University of GeorgiaRecruiting
-
Bayside HealthBeyondblue (The National Depression Initiative)CompletedDepression | AnxietyAustralia
-
Emory UniversityCompletedImplantable Cardioverter-defibrillators (ICDs)United States
-
Universidad Complutense de MadridCompleted
-
University of NebraskaDepartment of Health and Human ServicesCompletedNicotine Dependence | Cigarette SmokingUnited States
-
PfizerKaiser PermanenteActive, not recruitingRespiratory Syncytial VirusesUnited States
-
University of California, San FranciscoCenter for Research on Environment Health and Population Activities (CREHPA)Active, not recruiting
-
US Department of Veterans AffairsCompletedHIV Infections | Immune System Diseases | Delivery of Health Care | Health Care Quality, Access, and EvaluationUnited States
-
Montefiore Medical CenterNational Institute on Drug Abuse (NIDA); University of Pittsburgh; University...Active, not recruitingHIV Infections | Cannabis | Neuropathic PainUnited States
-
University of UtahNational Heart, Lung, and Blood Institute (NHLBI)WithdrawnVenous Thromboembolism | Pulmonary Embolism | Deep Venous Thrombosis | Bleeding as Surgical Complication (Treatment)