This study is a double-blind, randomized controlled trial designed to evaluate the
significance of a 7-week Cognitive Stimulation Therapy (CST) program compared to
continued maintenance-level care 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 begin with
research team members meeting site staff to present the study and prepare them to
identify eligible individuals based on the inclusion criteria. Site staff will then
provide a list of potential participants and access to relevant medical records, which
the research team will review before reaching out to potential participants or their
legal representatives via email, phone, or in person.
Interested participants or their Powers of Attorney (POAs) will receive an informational
handout explaining study expectations. If the POA expresses interest in participation, an
electronic version of the informed consent form, will be provided and reviewed. Research
team members will be available to address questions via phone, email, Zoom, or in person.
The signed consent form may be returned electronically, and a copy will be retained by
the participant or their POA.
Once 10 participants are enrolled, they will be randomly assigned to either the
intervention or control group using a computer-generated randomization list. Participants
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 a password-protected flash drive with encryption
and Google Sheets and OneDrive (Google Docs) documents. 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.