NightCAP: Reducing Hypnotic Drug Use and Improving Night-time Care
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Dementia
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Factorial AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 125 years
- Gender
- Both males and females
Description
The main objective of this current study is to explore the effectiveness of specific benefits of key components of the Night Time Care Activities Programme- NightCAP. Particularly elements of sleep hygiene and personalised night-time care planning. There may also be additional benefit in combining N...
The main objective of this current study is to explore the effectiveness of specific benefits of key components of the Night Time Care Activities Programme- NightCAP. Particularly elements of sleep hygiene and personalised night-time care planning. There may also be additional benefit in combining NightCAP elements with pharmacological review protocol to enable management of all major contributing factors in sleep disturbance. This nine-month cluster-randomised factorial proof-of-concept trial will be delivered in 24 UK care homes. Participants will be individuals living with dementia and experiencing sleep disturbance, as well as staff who care for them. Homes will be randomly allocated to one of eight arms. All homes will receive an optimised e-Learning programme; one of the eight is optimised usual care only. The remaining seven active interventions arms comprise of one, or a combination of two or three, of: (i) personalised night-time care planning (supported staff training and implementation); (ii) structured sleep hygiene (staff training); and (iii) hypnotic drug review protocol (GP and staff training). Across all 24 homes, 12 will receive each active intervention (alone or in combination). The primary contrast is hypnotic drug review vs no hypnotic drug review. The primary outcome will be hypnotic drug use at the end of intervention delivery. Secondary outcomes will be behaviour symptoms, sleep disturbance, quality of life, resident falls, job satisfaction, burden and coping in care staff, and cost effectiveness.
Tracking Information
- NCT #
- NCT04373668
- Collaborators
- King's College London
- University of East Anglia
- Aston University
- Investigators
- Study Chair: Anne Corbett University of Exeter