NightCAP: Reducing Hypnotic Drug Use and Improving Night-time Care
NightCAP
Reducing Hypnotic Drug Use and Improving Night-time Care for People Living With Dementia in Care Homes (NightCAP): A Randomised Factorial Trial
1 other identifier
interventional
720
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2020
CompletedFirst Posted
Study publicly available on registry
May 4, 2020
CompletedStudy Start
First participant enrolled
November 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2023
CompletedJuly 27, 2022
July 1, 2022
1.5 years
April 28, 2020
July 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sleep Disturbance Inventory SDI
Sleep disturbance behaviour as measured by the Sleep Disturbance Inventory SDI
From baseline and immediately after intervention
Secondary Outcomes (11)
Change of Hypnotic Drug Use
From baseline, immediately after intervention and at four months follow-up
Dementia Quality of Life
From baseline, immediately after intervention and at four months follow-up
Neuropsychiatric Inventory- Nursing Home (NPI-NH)
From baseline, immediately after intervention and at four months follow-up
Cohen-Mansfield Agitation Inventory (CMAI)
From baseline, immediately after intervention and at four months follow-up
Global Deterioration Scale (GDS)
From baseline, immediately after intervention and at four months follow-up
- +6 more secondary outcomes
Study Arms (2)
Control, optimised usual care
NO INTERVENTIONTreatment delivered as usual in the care home
Hypnotic Drug Review, Structured Sleep Hygiene and NightCAP
EXPERIMENTALCare homes to receive all three interventions: Hypnotic Drug Review, Structured Sleep Hygiene and NightCAP interventions
Interventions
A training programme focused providing guidance on the review and withdrawal process of hypnotic drugs.
Training module on the principle of good sleep hygiene
Training and support package to assist in the development of a personalised night time care plan and support the implementation and dissemination of information within the care home environment
Eligibility Criteria
You may qualify if:
- Care homes (inclusive of residential and nursing) that have failed to meet more than 1 of the 5 CQC care home quality standards check
- Care homes who have at least 12 eligible care home resident participants
- Care homes with a minimum of two residents who are eligible to participate in the study taking hypnotic medication
- Resident participants will have an established or probable diagnosis of dementia
- Residents will have experienced an episode/occurrence of sleep disturbance behaviour in the past four weeks/two weeks (as reported by care staff)
- Care home member of staff whose duties include providing care to individuals with dementia
- Care home care staff are required to have an adequate level of English language to complete all required assessment outcomes
- Care home care staff participants who will remain in work without plans for extended leave over the study period
You may not qualify if:
- Care homes receiving special support from the local authority
- Agency care staff
- Care staff will be able to withdraw from the study at any time
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Exeterlead
- King's College Londoncollaborator
- University of East Angliacollaborator
- Aston Universitycollaborator
Study Sites (1)
University of Exeter
Exeter, Devon, EX1 2LU, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Anne Corbett
University of Exeter
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2020
First Posted
May 4, 2020
Study Start
November 1, 2021
Primary Completion
April 30, 2023
Study Completion
April 30, 2023
Last Updated
July 27, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share