. Author manuscript; available in PMC: 2024 Feb 1.

Published in final edited form as: J Am Geriatr Soc. 2022 Nov 26;71(2):588–598. doi: 10.1111/jgs.18128

Table 2.

Three example CRTs involving PLWD in LTC homes

Example 1: Managing Agitation and Raising Quality of Life (MARQUE) Trial¹⁸
Aim: Evaluate the effectiveness of the MARQUE intervention: training to teach healthcare professionals in LTC homes strategies to manage agitation.
Design: Parallel arm CRT involving 20 LTC homes in England.
Intervention: Developed with involvement from healthcare professionals, patients, and community representatives. LTC home staff were trained about the etiology and management of agitation and were given feedback on performance.
Data collection: Cohen-Mansfield Agitation Inventory and the Neuropsychiatric Inventory at baseline and at 8 months post-training. Proxy-rated quality of life of each PLWD by interviewing a healthcare professional or a family caregiver.
Results: No reduction in agitation or improvement in quality of life.
Consent procedures: Researchers obtained informed consent for participation from healthcare professionals. Researchers assessed the decision-making capacity of PLWD using the Mental Capacity Act 2005 criteria and obtained informed consent for participation from PLWD with capacity. For PLWD who lacked capacity, researchers obtained surrogate consent for trial participation from a family caregiver or professional consultee. Gatekeeper permission to enrol each LTC home was obtained from the LTC home manager.

Example 2: Elastic Trial¹⁹
Aim: Evaluate the effectiveness of the Wheelchair-using Senior Elastic Band (WSEB) intervention: group exercise sessions designed for wheelchair-using PLWD in LTC homes.
Design: Parallel arm CRT involving 8 LTC homes in Southern Taiwan.
Intervention: WSEB group exercise sessions involving aerobic and resistance training were led by instructors who regularly volunteered in each LTC home and took place thrice weekly for 6 months. Additional instructors were present during exercise sessions to monitor PLWD for physical discomfort.
Data collection: Researchers performed physical assessments, measuring activities of daily living, flexibility, joint range of motion, cardiopulmonary function, and muscle strength and endurance.
Results: Significant improvement in functional fitness and performance of activities of daily living.
Consent procedures: Researchers obtained assent for participation from PLWD and surrogate consent for participation from their family caregivers. Researchers did not report conducting capacity assessments.

Example 3: Bath trial²⁰
Aim: Evaluate the effectiveness of the Bathing Without a Battle (BWAB) intervention: training to teach healthcare professionals in LTC homes noncoercive, individualised, person-centered bathing techniques to make bathing PLWD safe and comfortable.
Design: Stepped wedge CRT involving 6 LTC homes in New York State, USA.
Intervention: Healthcare professionals were taught to (1) effectively communicate with PLWD, (2) understand behavioural symptoms as an expression of unmet needs, (3) respect the preferences of PLWD, and (4) ensure the physical environment is safe.
Data collection: Researchers directly observed each bath and documented physical and verbal aggressive behaviour exhibited by PLWD. Use of antipsychotic medication on bath days was collected from medical records.
Results: Significant reduction in agitation during baths and anti-psychotic use on bath days.
Consent procedures: LTC home administrators sought informed consent for participation from healthcare professionals. LTC home administrators sought informed consent for participation from either PLWD or their family caregiver. Researchers reported conducting capacity assessments but did not state how capacity was assessed.