Clinical trial NCT04373668: NightCAP: Reducing Hypnotic Drug Use and Improving Night-time Care
Official title: Reducing Hypnotic Drug Use and Improving Night-time Care for People Living With Dementia in Care Homes (NightCAP): A Randomised Factorial Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dementia
Keywords: Dementia
Care Homes
Hypnotic Medication
Night Time Care
Behavioural symptoms
Cost effectiveness
Lead sponsor: University of Exeter
Sponsor class: OTHER
Collaborators: name: King's College London
name: University of East Anglia
name: Aston University
First posted: 2020-05-04
Enrollment: 720
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Sleep Disturbance Inventory SDI
timeFrame: From baseline and immediately after intervention
Secondary outcomes:
measure: Change of Hypnotic Drug Use
timeFrame: From baseline, immediately after intervention and at four months follow-up
measure: Dementia Quality of Life
timeFrame: From baseline, immediately after intervention and at four months follow-up
measure: Neuropsychiatric Inventory- Nursing Home (NPI-NH)
timeFrame: From baseline, immediately after intervention and at four months follow-up
measure: Cohen-Mansfield Agitation Inventory (CMAI)
timeFrame: From baseline, immediately after intervention and at four months follow-up
measure: Global Deterioration Scale (GDS)
timeFrame: From baseline, immediately after intervention and at four months follow-up
measure: Client Service Receipt Inventory (CSRI)
timeFrame: From baseline, immediately after intervention and at four months follow-up
measure: Functional Assessment Staging (FAST)
timeFrame: From baseline, immediately after intervention and at four months follow-up
measure: EQ5D-5L
timeFrame: From baseline, immediately after intervention and at four months follow-up
measure: Abbey Pain Scale
timeFrame: From baseline, immediately after intervention and at four months follow-up
measure: Approached to Dementia Questionnaire (ADQ)
timeFrame: From baseline, immediately after intervention and at four months follow-up
measure: Patient Health Questionnaire 9 (PHQ-9)
timeFrame: From baseline, immediately after intervention and at four months follow-up
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: University of Exeter
state: Devon
Study officials:
affiliation: University of Exeter
name: Anne Corbett
role: STUDY_CHAIR
References: