Internet Data Collection Clinical Trial
Official title:
Is Internet Data Collection Superior to Traditional Methods in Retaining Participants in Longitudinal Research?
One of the biggest challenges of conducting research where the investigators follow people
over a long period of time is keeping the participants involved. One of way that
investigators may be able to improve participant involvement in research is to give
participants the opportunity to complete their questionnaires online.
Here's how the investigators think the Internet data collection system will help to keep
participants involved and ultimately help to answer important questions about the effects of
nutrition during pregnancy:
1. It will allow investigators to present complicated questionnaires in a way that doesn't
confuse participants. For example, instead of telling participants to skip the
remainder of a question if they answered no to the first part of the question, the ePRO
system does the skipping for them. The result is less confusion, fewer questions to
read, and less of the participant's time.
2. It provides a convenient way for participants to keep track of where to find the
questionnaire, and how much they have already completed. Participants sometimes don't
have time to answer all of the investigator's questions in one sitting. The ePRO system
keeps track of how much participants have already done and it's ready to keep going
whenever the participant has time. It also avoids the common problem of losing the
questionnaires to the household paperwork pile, or worse to the recycling bin.
3. It provides timely reminders to participants. Study participants, and especially new
moms, are busy and they forget to complete the questionnaires. The ePRO system can
provide timely reminders encouraging participants to respond.
4. It helps participants complete the questionnaires accurately. The ePRO system has an
automatic error detection ability that will alert participants to any questions they
missed or completed incorrectly.
Finding ways to keep participants involved in research is something that all researchers are
concerned about, and ultimately it's a concern for all Canadians because the results of
research are often used to make decisions about health care and the kinds of programs that
governments provide. Losing any participant from the study reduces the ability of policy
makers to take the best decisions and choices about what health services to fund with
limited dollars. What the investigators propose is a study to determine whether Internet
data entry really will keep participants involved in a longitudinal study. Previous studies
have shown that the internet can be a useful tool for getting people to sign up for research
and at least one small study showed that using Internet data entry can actually save money.
But no researchers have actually tested whether it really does a better job than paper based
questionnaires in terms of keeping participants involved.
In order to answer this question, the investigators will randomly assign the current Alberta
Pregnancy Outcomes and Nutrition study participants to either continue receiving the
paper-based questionnaire or to start receiving the web-based surveys. The investigators
will follow participants over three assessment occasions (over a period of 18 months) and
observe any differences between the groups in their involvement. Because the investigators
are randomly assigning participants to the two groups, differences in involvement will tell
them about usefulness of Internet data entry as a participant retention tool.
RESEARCH QUESTIONS: In longitudinal research, will participant-initiated internet data entry
improve 1) participant retention and 2) data quality? RESEARCH CONTEXT: While longitudinal
research may be the best tool for examining the course of human health and illness over the
lifespan, the burden of participation over many years often results in loss of participants
to follow-up. Such attrition reduces statistical power and threatens the internal validity
and generalizability of inferences drawn from longitudinal data (Shadish et al., 2002).
Because internet data collection is convenient and simplifies complex questionnaires, this
method may reduce participant burden and reduce attrition. While internet data collection is
already regarded as a viable tool for participant recruitment (Smith et al., 2007) and
usually results in data of equivalent or better quality (e.g., factor loadings,
reliabilities) than traditional paper-and-pencil methods (Vergnaud et al., 2011), internet
data collection as a tool to increase participant retention within an existing longitudinal
cohort has not been evaluated previously. The goal of the current project is to determine
whether internet data collection increases participant retention and data quality within the
APrON (Alberta Pregnancy Outcomes and Nutrition) study.
APrON is an ongoing longitudinal cohort study conducted in Calgary and Edmonton, involving
more than 2000 women, 1200 of their partners, and their 2000 children. It is designed to
answer questions about the impact of maternal nutrient intake and status during pregnancy
on: a) maternal mental health, b) birth outcomes, and c) child health and development. The
data collected from Albertans participating in health research (such as APrON) is a
provincial treasure, an investment that needs to be maximized with easy, modern technology
to reduce participant burden and promote better long-term follow-up. Although software is
available for single questionnaire data entry (e.g., RedCap), the innovative technology the
investigators plan to introduce and evaluate is a made-in-Alberta solution that automates
and simplifies the collection of complex short- and long-term longitudinal data - a process
that other software cannot easily achieve. This technology holds strong potential for broad
application to all longitudinal health research.
Currently, APrON collects data using traditional paper questionnaires mailed out at regular
intervals throughout pregnancy and as children develop over the first 3 years. At some time
points, participants are also asked to attend a clinic where biological samples and physical
measures are taken. The questionnaires are long and complex (whether a question needs to be
answered is dependent upon responses to previous questions) and have been identified as a
major time burden by study participants. In a recent survey of 1763 APrON participants,
almost 65%, indicated they would prefer to complete study questionnaires via the internet -
most of the remainder had no preference. Completion rate for paper questionnaires is
approximately 85% when participants come to a study clinic for an in-person visit. However,
when a clinic visit does not accompany the mailed questionnaires (questionnaires are
completed at home and returned by postage paid envelope) response rates are ~ 65%.
RESEARCH PLAN/METHODOLOGY: Electronic Patient Reported Outcomes (ePRO) is a web-based
software tool developed by the Women & Children's Health Research Institute (WCHRI) at the
University of Alberta. Pilot studies have been performed at the University of Alberta,
however, this study will be the first use of ePRO in a study population of this size.
Questionnaires are built using Checkbox Survey Server. Automatic email invitations to
participants are based on the individualized anchor dates and schedules (e.g., the
questionnaire for children aged 12 months is linked to the individual child's date of
birth). Participants receive links and instructions when a survey is due for completion.
Reminders are automatically sent if a questionnaire is not completed within appropriate
timelines (e.g., after 2 weeks). Study staff can track late and incomplete questionnaires,
re-send invitations, and manually enter data when information is obtained via a paper
questionnaire or telephone interview. Importantly, the system facilitates linking of data
from different questionnaires and different time points.
The investigators propose a randomized trial of data collection methods. Participants will
be allocated using a permuted block randomization of equal block sizes from APrON
participants in Calgary to one of two groups: (1) continue with paper-based data collection;
and (2) use ePRO for future data collection tasks.
IMPACT/RELEVANCE: In 2008, Alberta invested significant research funds to establish
pregnancy and birth cohorts that will help develop knowledge needed to improve the health of
mothers and infants. Answering health questions about developmental effects requires
continued contact and follow-up with the participants every 3-6 months, which is a
significant challenge, and one which most international cohorts are struggling to accomplish
with paper questionnaires. What the investigators propose in this grant is to evaluate a
novel approach to complex longitudinal research that enables data collection that is
convenient, less burdensome, and efficient for participants. The investigators expect that
the ePRO system will: 1) increase completion rate by tracking participant progress in the
study, notifying them when it is time for another round of questionnaires, administering
questionnaires in an efficient manner (skip non-relevant questions), and sending reminders
about incomplete questionnaires, and 2) improve data quality by alerting participants to
missing items.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label