Scientific Concept of the National Cohort (status ... - Nationale Kohorte

A.3
A.3 Study design
with a prepared prepaid reply card indicating convenient examination dates. If the second
invitation does not lead to a contact with the subject or has not verified their response state
(e. g., moved away with unknown address, too ill to participate in the study, deceased, or
unwilling to participate in the study), a home visit may be conducted by trained study personnel.
Several attempts will be made to locate the study subject or to retrieve information
from relatives or neighbors regarding the subject’s correct address of residence or telephone
number, or their willingness or ability to participate. For subjects without a registered
telephone number two invitation letters including prepaid reply cards will be sent before
considering a home visit. All direct contact attempts are made by trained and certified study
personnel and are documented in detail.
In order to accommodate the needs and time restraints of an active working population, active
phone calls aimed at contacting potential study subjects will cover all times of the day
and evening as well as weekends.
Important organizational tasks to be performed by the study personnel responsible for contacting
the invited subjects and organizing the recruitment are:
� To schedule an appointment for the examination
� To confirm or change a prebooked appointment
� To contact people who have not responded to the reminder letter
� To record telephone/cell phone number and e-mail details in case the appointment
must be canceled or changed
� To send email or SMS text reminders before the appointment
� To contact people who missed their appointment
� To supply nonresponder questionnaires or to conduct short nonresponder interviews
with subjects unwilling to participate in the study
� To provide information about the study, procedures involved in the recruitment, organizational
aspects, and to clarify concerns
� To cancel the invitation and ensure the invitee is not contacted further (in case of withdrawal)
Previsit reminder message
When potential participants agree to participate, they will be asked to provide an e-mail
address and/or cell phone number. With the participant’s agreement, these contact details
may be used to send an appointment reminder by e-mail or SMS text shortly before their
scheduled appointment.
Written material provided to the study participants prior to the appointment
The first invitation mailing will include a participant information leaflet providing basic information
about the National Cohort, including the aims of the study, funders, and organization.
Furthermore, the information leaflet will briefly inform potential participants about the
examinations and interview. A reminder letter will contain the same information material.
A letter confirming the date of examination will be sent to subjects who agreed to participate
in the study and contains a map of the study center, a brief, self-administered questionnaire,
and specific instructions on how to prepare for the study (e. g., fasting state if needed), and
what to bring to the study center (e.g., packages of medication, reading glasses, or completed
questionnaire).
It will also provide the address of the study website with further information and the telephone
number for further questions. Prior to the assessment, participants will receive more
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