This study is a quasi-experimental one group pretest-posttest designed to evaluate the
significance of a 7-week Cognitive Stimulation Therapy (CST) program among residents of a
skilled nursing facility with mild to moderate dementia. The primary aim is to assess the
impact of CST on cognitive functioning and occupational engagement.
The study will be conducted at Ridgewood Health Campus and aims to enroll approximately
10 participants over an estimated period of 1-2 months. Recruitment has been 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 will reviewed before reaching out to potential
participants and/or their legal representatives via email, phone, or in person.
Interested participants or 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 are enrolled, they will first complete a one-week screening period,
followed by one week of pre-testing. The CST intervention will be 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) have completed formal training through the North American
Cognitive Stimulation Therapy Training Institute. The CST practice manual will also be
strictly followed. The research team will collaborate 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 will follow all HIPAA and
facility protocols and report the incident to the PI.
Given the vulnerability of the participant population, the research team has prioritized
ethical considerations. All study materials, including the participant handout and
consent forms, are written in plain language and at an appropriate reading level. POAs
are given adequate time and support to make informed decisions. Additionally, a licensed
occupational therapist in the state of Indiana who is familiar with the participants will
be present during sessions to help meet their individual needs and advocate on their
behalf.
Participation is entirely voluntary, and participants may withdraw from the study at any
time without penalty or loss of benefits. Participants may also decline individual
sessions or activities without consequence. During evaluations, participants can skip any
question they do not wish to answer. Data from assessments will be included in analysis
only if at least 75% of items are completed. Likewise, if a participant attends at least
11 of the 14 scheduled CST sessions (~75%), their data will be retained for analysis.
Data from participants who attend fewer sessions or withdraw will be excluded from
analysis, and this will be 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 remains. Psychological effects will be monitored, and any incident
will 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 will be managed using an encrypted password-protected flash drive with
encryption and a password protected file folder. Participant names will be linked to
unique ID codes necessary for tracking consent and study progress. Only coded identifiers
will be used in outcome data collection. Names will be 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 is restricted to the PI and four (Collaborative Institutional Training
Initiative program) CITI-certified research members. Documents are stored on a secure,
shared, encrypted, and password-protected flash drive. All team members' laptops are
password-protected and use two-factor authentication. Devices are stored securely when
not in use, and team members adhere to strict data security practices when in public
settings.
All study procedures will comply with Northern Kentucky University's institutional
ethical guidelines. Any protocol changes have been, and will continue to be, submitted to
the Institutional Review Board (IRB) for approval. Data management follows validated
protocols with comprehensive quality control measures to ensure the integrity and
confidentiality of all collected data.