Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-24 @ 5:49 PM
Study NCT ID:
NCT04373668
Status:
UNKNOWN
Last Update Posted:
2022-07-27
First Post:
2020-04-28
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
NightCAP: Reducing Hypnotic Drug Use and Improving Night-time Care
Sponsor:
University of Exeter
Organization:
Study Overview
Official Title:
Reducing Hypnotic Drug Use and Improving Night-time Care for People Living With Dementia in Care Homes (NightCAP): A Randomised Factorial Trial
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NightCAP
Brief Summary:
Dementia is a devastating condition characterised by progressive loss of cognition leading to loss of independence and eventually death. One major unmet need, which remains a critical challenge for care provision, is the management of night-time care and sleep-related symptoms in people with dementia living in care homes. The causes and impacts of sleep disturbances in people with dementia in care homes are complex and multi-faceted, indicating the need of a whole-systems approach to the issue. It will require a tailored, person-centred approach which accounts for the environmental, personal and clinical factors contributing to the symptoms.
The aim of this study is to evaluate the NightCAP intervention to improve treatment of sleep disturbance in people with dementia in care homes, with the goal of reducing sleep disturbance behaviour and reducing the use of hypnotic drugs. This will provide robust evidence to support guidance on night time care and improving hypnotic drug prescribing, both of which are major unmet needs in the care of people with dementia.
The aim of this study is to evaluate the NightCAP intervention to improve treatment of sleep disturbance in people with dementia in care homes, with the goal of reducing sleep disturbance behaviour and reducing the use of hypnotic drugs. This will provide robust evidence to support guidance on night time care and improving hypnotic drug prescribing, both of which are major unmet needs in the care of people with dementia.
Detailed 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 NightCAP elements with pharmacological review protocol to enable management of all major contributing factors in sleep disturbance.
This cluster-randomised 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 two arms: optimised usual care or the intervention arm. All homes will receive an optimised person-centred care module. The NightCAP intervention programme consists of three key elements: (i) personalised night-time care planning (supported staff training and implementation); (ii) structured sleep hygiene (staff training); and (iii) hypnotic drug review protocol (GP fact sheet and staff training). The primary outcome will be sleep disturbance at the end of the intervention. Secondary outcomes will be hypnotic drug use, quality of life, resident falls, job satisfaction, burden and coping in care staff, and cost effectiveness.
This cluster-randomised 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 two arms: optimised usual care or the intervention arm. All homes will receive an optimised person-centred care module. The NightCAP intervention programme consists of three key elements: (i) personalised night-time care planning (supported staff training and implementation); (ii) structured sleep hygiene (staff training); and (iii) hypnotic drug review protocol (GP fact sheet and staff training). The primary outcome will be sleep disturbance at the end of the intervention. Secondary outcomes will be hypnotic drug use, quality of life, resident falls, job satisfaction, burden and coping in care staff, and cost effectiveness.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: