This study was a quasi-experimental one group pretest-posttest designed to evaluate the
significance of a 7-week CST program among residents of a long-term care facility with
mild to moderate dementia. The primary aim was to investigate the preliminary effect of
CST on cognition and engagement in individuals with mild-to-moderate dementia.
The study was conducted at Ridgewood Health Campus and aimed to enroll approximately 10
participants over an estimated period of 1 to 2 months. Recruitment was completed with
one research team member meeting site staff, where she presented the study and prepared
them to identify eligible individuals based on the inclusion criteria. Site staff then
provided a list of potential participants and gave access to relevant medical records,
which the research team reviewed before reaching out to potential participants and/or
their legal representatives via email, phone, or in person.
Interested participants and their Powers of Attorney (POAs) received an informational
handout explaining study expectations. If the POA expressed interest in participation, an
electronic version of the informed consent form was provided and reviewed. Research team
members were available to address questions via phone, email, Zoom, or in person. The
signed consent forms were returned electronically or physically, and a copy was retained
by the participant and/or their POA.
As 10 participants enrolled, they first completed a one-week screening period, followed
by one week of pre-testing. The CST intervention was administered twice weekly for 45
minutes over 7 weeks, followed by a one-week post-intervention assessment period.
To ensure fidelity of the CST intervention, the Principal Investigator (PI) and
Co-Investigators (Co-PIs) completed formal training through the North American Cognitive
Stimulation Therapy Training Institute through Saint Louis University, School of
Medicine. The CST practice manual was also followed strictly. The research team then
collaborated closely with on-site staff to address concerns related to participant
safety, treatment environment, or study procedures. In the event of an adverse event, the
research team planned to follow all HIPAA and facility protocols and planned to report
the incident to the PI.
Given the vulnerability of the participant population, the research team prioritized
ethical considerations. All study materials, including the participant handout and
consent forms, were written in plain language and at an appropriate reading level. Power
of Attorneys were given adequate time and support to make informed decisions.
Additionally, on-site staff (nursing staff and aides) who were familiar with the
participants were present during sessions to help meet their individual needs and
advocate on their behalf. Additionally, because occupational therapy students
co-facilitated the CST sessions, a licensed occupational therapist was present for all
sessions to ensure participant safety and to ensure proper implementation of the
intervention.
Participation was entirely voluntary, and participants could withdraw from the study at
any time without penalty or loss of benefits. Participants were able to decline
individual sessions or activities without consequence. During evaluations, participants
were able to skip any question they did not wish to answer. Data from assessments were
included in the analysis only if at least 75% of items were completed per participant. If
a participant attended greater than or equal to 50% of the scheduled sessions (7 out of
14 sessions), their data was retained for analysis. Data from participants who attended
fewer than 7 sessions were planned to be included from analysis, and this was addressed
in the final report.
CST has not been associated with harmful side effects in previous studies, suggesting
minimal risk to participants. Nonetheless, the possibility of emotional discomfort or
other adverse events remained. Psychological effects were monitored, and any incident was
planned to be addressed promptly following institutional and facility procedures. A
potential risk includes unintentional disclosure of identifiable information, although
safeguards have been implemented to mitigate this.
Data collection was managed using an encrypted password-protected flash drive with
encryption and a password-protected file folder. Participant names were linked to unique
ID codes necessary for tracking consent and study progress. Only coded identifiers were
used in outcome data collection. Names were recorded solely on consent forms and a
separate secure document linking names to ID codes, which will be stored for six years in
accordance with data retention policies. After this period, all physical and electronic
data will be securely destroyed.
Access to data was and will continue to be restricted to the PI and four Collaborative
Institutional Training Initiative program (CITI) certified research members. Electronic
documents were stored on two secure, encrypted, and password-protected flash drives. All
team members' laptops are password-protected and use two-factor authentication. Devices
have been and will continue to be stored securely when not in use, and team members
adhere to strict data security practices when in public settings. Physical copies of data
are stored in a password-protected file folder and stored with the faculty advisor.
All study procedures comply with Northern Kentucky University's institutional ethical
guidelines. All protocol changes were submitted to the Institutional Review Board (IRB)
before the start of the intervention and were approved. Data management followed
validated protocols with comprehensive quality control measures to ensure the integrity
and confidentiality of all collected data.
