Fostering Positive Care Interactions in Assisted Living
ConditionDementia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorUniversity of Maryland, Baltimore
About this trial
The purpose of this study is to improve the quality of staff-resident care interactions particularly among residents living with Alzheimer's disease or related dementias (ADRD ) by testing the Fostering Positive Care Interactions in Assisted Living (FPCI-AL) intervention. This study will be a critical first step in determining the sample size needed to test the efficacy of a practical approach to improving the quality of care interactions for assisted living residents living with ADRD, ultimately enhancing behavioral outcomes such as decreasing behavioral symptoms of distress, reducing resistiveness to care, and optimizing engagement in care tasks.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
55 years of age or older
currently residing in a participating community
Evidence of ADRD based on a score ≤20 on the Saint Louis University Mental Status Examination
Disqualifiers
Admitted to the assisted living for short term care
Trial design
Design model
Parallel
Treatments tested in this trial
FPCI-AL
BehavioralFollowing randomization, champions and stakeholder team members from the communities will be identified. The investigators will recommend the following individuals to be members of the stakeholder team: assisted living administrator, nurse manager, nursing assistant, and activity and rehabilitation staff as available. Following the initial team meeting, the research facilitator will work with each treatment assisted living community for eight hours weekly during months one and two, and then for four hours weekly for the remaining four months using a face-to-face approach to implement the four components of the FPCI-AL.
Education Only (EO)
BehavioralCommunities randomized to education only will receive the same education as provided in FPCI-AL step two via an established PowerPoint. Delivery format will match community preferences (e.g., online or in-person) for pragmatic reasons and to facilitate the education process.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: FPCI-ALExperimental treatment 1 intervention
Group B: Education Only (EO)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Modified Quality of Interactions Scale
Quality of care interactions will be measured using the Modified Quality of Interactions Scale, an observational tool that measures interaction characteristics and quality using a quantified scoring system. It records the care interaction location, type of care activity, and type of care provider in care (e.g., nurse). The total score ranges from 0 to 7, with higher scores indicating better, more positive interactions.
Time frame
Baseline, 4 months, 6 monthsSecondary outcomes
1
Neuropsychiatric Inventory Questionnaire
The Neuropsychiatric Inventory Questionnaire (NPI-Q) assesses the presence, severity, and impact on caregivers of 12 behavioral symptoms of distress (e.g., delusions, hallucinations, anxiety). For the purposes of this study only the presence of behavior will be considered. The total score ranges from 0 to 12, with higher numbers indicating more behavioral symptoms of distress.
Time frame
Baseline, 4 months, 6 months2
Resistiveness to Care Scale
Resistiveness to care will be assessed during care interactions using the Resistiveness to Care Scale, which measures the frequency of 16 resistive behaviors (e.g., kicking, hitting). The total score ranges from 0 to 16, with higher scores indicating more resistiveness to care behaviors.
Time frame
Baseline, 4 months, 6 months3
Resident Engagement with Staff During Care Interactions
The Modified Quality of Interaction Scale item, "What is the level of resident engagement?", will be used during assessments of staff-resident care interactions to record resident engagement as active, passive, or restrictive.
Time frame
Baseline, 4 months, 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Maryland, Baltimore
Lead sponsor
Alzheimer's Association
Collaborator
Source ClinicalTrials.gov