An interventional study of Hypnotic Medication Review and Structured Sleep Hygiene in Dementia, sponsored by University of Exeter. Status unknown at 1 site in United Kingdom. Per ClinicalTrials.gov, last updated 2022-07-27.
Sponsored by University of Exeter · Not applicable, Interventional, and Treatment
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 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.
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's planned enrollment of 720 is above the median of 83 across 1,629 interventional studies indexed under Dementia.
Browse Dementia studies →University of Exeter is the lead sponsor of 138 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment delivered as usual in the care home
Care homes to receive all three interventions: Hypnotic Drug Review, Structured Sleep Hygiene and NightCAP interventions
Behavioral: Hypnotic Medication Review · Behavioral: Structured Sleep Hygiene · Behavioral: Night Time Care Activities Programme
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
Sleep Disturbance Inventory SDI
Sleep disturbance behaviour as measured by the Sleep Disturbance Inventory SDI
Time frame: From baseline and immediately after intervention
Change of Hypnotic Drug Use
Hypnotic drug use assessed from the care home Medication Administration Record
Time frame: From baseline, immediately after intervention and at four months follow-up
Dementia Quality of Life
Quality of life assessed using DEMQOL-Caregiver. Consisting of 32 questions the DEMQOL-Caregiver is an interviewer administered measure, with higher scores indicating better quality of life.
Time frame: From baseline, immediately after intervention and at four months follow-up
Neuropsychiatric Inventory- Nursing Home (NPI-NH)
The NPI is a validated structured interview assessment with the informant (care staff), that assesses behavioural disturbances in patients with dementia. This 12-item version consists of 10 behavioural and two neurovegetative areas. It provides both a total score as well as scores for a number of sub-scales (e.g. delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, disinhibition, elation/euphoria, apathy/indifference, irritability/lability, aberrant motor activity, sleep, and appetite/eating disorders). The frequency, severity and caregiver distress for each domain are measured. The total possible maximum score is 144. A higher score reflects increased frequency and severity of the disturbances. This specific version is developed for use in care homes, with adapted questions in the standardised interview and the caregiver distress assessment adapted to occupation disruptiveness.
Time frame: From baseline, immediately after intervention and at four months follow-up
Cohen-Mansfield Agitation Inventory (CMAI)
The CMAI is a caregivers' rating questionnaire to specify agitated behaviour (Cohen-Mansfield et al, 1980). The CMAI consist of 29 items related to agitated behaviour, each of which is rated on a 7- point scale of frequency, from 1= never to 7= several times an hour. The rating is based on a face-to-face interview with a caregiver.
Time frame: From baseline, immediately after intervention and at four months follow-up
Global Deterioration Scale (GDS)
The GDS is a staging scale indicating deterioration in dementia. The scale details clinical descriptions of seven major distinguishable stages, ranging from normal cognition to severe dementia. Stages 1-3 are the pre dementia stages/ Stages 4-7 reflect the stages of dementia.
Time frame: From baseline, immediately after intervention and at four months follow-up
Client Service Receipt Inventory (CSRI)
The CSRI is used to estimate the cost of service packages for each participant in the study. Information is collected on the current living arrangements, use of hospital, community-based and day services. The data collected through the CSRI can be used to calculate service costs and total costs of care.
Time frame: From baseline, immediately after intervention and at four months follow-up
Functional Assessment Staging (FAST)
FAST is a proxy-rated instrument validated for use in people with dementia. It ascertains the severity of dementia in seven stages of functioning.
Time frame: From baseline, immediately after intervention and at four months follow-up
EQ5D-5L
The EQ5D-5L is a measure of Health Related Quality of Life. The EQ5D-5L consist of the EQ5D descriptive system and the EQ visual analogue scale (EQ VAS).
Time frame: From baseline, immediately after intervention and at four months follow-up
Abbey Pain Scale
The Abbey Scale is an observation brief indicator of pain for people with end-stage dementia. The scale is rated on six non verbal indicators of pain where 0 is none and 3 is severe
Time frame: From baseline, immediately after intervention and at four months follow-up
Approached to Dementia Questionnaire (ADQ)
The ADQ is a 19-item instrument. Responses are indicated using a 5-point Likert scale. Higher values represent a better outcome (range from 19-96). The ADQ includes two subscales: person-centredness and hopefulness.
Time frame: From baseline, immediately after intervention and at four months follow-up
Patient Health Questionnaire 9 (PHQ-9)
A measure of carer mental health and behaviour consisting of 9 questions
Time frame: From baseline, immediately after intervention and at four months follow-up
Plan to share: No
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University of Exeter