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The NICOLA Questionnaire Trial (NICOLA-QT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01978522
Recruitment Status : Completed
First Posted : November 7, 2013
Last Update Posted : April 11, 2018
Information provided by (Responsible Party):
Lisa Maguire, Queen's University, Belfast

Brief 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 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

Condition or disease Intervention/treatment Phase
Healthy Cohort Other: Randomisation of questionnaire receipt. Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8500 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
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.
Actual Study Start Date : January 1, 2014
Actual Primary Completion Date : December 20, 2015
Actual Study Completion Date : December 20, 2016

Arm Intervention/treatment
Experimental: NICOLA Participants
All participants enrolled in the NICOLA cohort
Other: 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.

Primary Outcome Measures :
  1. Influence of group on questionnaire return rates [ Time Frame: Within two months ]

Secondary Outcome Measures :
  1. Influence of group on questionnaire completeness [ Time Frame: Within two months ]
  2. Influence of group on time taken to return questionnaire [ Time Frame: Within two months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01978522

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United Kingdom
Lisa Maguire
Belfast, Northern Ireland, United Kingdom, BT12 6BJ
Sponsors and Collaborators
Queen's University, Belfast
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Principal Investigator: Mike Clarke, PhD Queen's University, Belfast

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Responsible Party: Lisa Maguire, Research Fellow, Queen's University, Belfast Identifier: NCT01978522     History of Changes
Other Study ID Numbers: QUB-1112-QT
First Posted: November 7, 2013    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Keywords provided by Lisa Maguire, Queen's University, Belfast:
Randomised trial
postal questionnaires
return rates