DementiaNightCAPNCT04373668
NightCAP: Reducing Hypnotic Drug Use and Improving Night-time Care
A study testing Hypnotic Medication Review, Structured Sleep Hygiene and Night Time Care Activities Programme in people with Dementia, run by University of Exeter at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia
- What is being tested?
- Hypnotic Medication Review, Structured Sleep Hygiene and Night Time Care Activities Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2021to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Exeter
Exeter, Devon, EX1 2LU
Kayleigh Nunez, k.nunez@exeter.ac.uk
About this study
Official title: Reducing Hypnotic Drug Use and Improving Night-time Care for People Living With Dementia in Care Homes (NightCAP): A Randomised Factorial Trial
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.
Read the 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.
- Conditions
- Dementia
- Being tested
- Hypnotic Medication Review, Structured Sleep Hygiene, Night Time Care Activities Programme
- Keywords
- Dementia, Care Homes, Hypnotic Medication, Night Time Care, Behavioural symptoms, Cost effectiveness
- Medical subject headings
- Dementia, Behavioral Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypnotic Medication ReviewBehavioural
A training programme focused providing guidance on the review and withdrawal process of hypnotic drugs.
Structured Sleep HygieneBehavioural
Training module on the principle of good sleep hygiene
Night Time Care Activities ProgrammeBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Control, optimised usual care | No intervention | Treatment delivered as usual in the care home |
| Hypnotic Drug Review, Structured Sleep Hygiene and NightCAP | Experimental | Care homes to receive all three interventions: Hypnotic Drug Review, Structured Sleep Hygiene and NightCAP interventions Receives: Behavioral: Hypnotic Medication Review; Behavioral: Structured Sleep Hygiene; Behavioral: Night Time Care Activities Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Disturbance Inventory SDI
Sleep disturbance behaviour as measured by the Sleep Disturbance Inventory SDI
Measured: From baseline and immediately after intervention
Secondary outcomes (11)
Change of Hypnotic Drug Use
Hypnotic drug use assessed from the care home Medication Administration Record
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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
Measured: From baseline, immediately after intervention and at four months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start1 Nov 2021
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, University of East Anglia, Aston University
- Responsible party
- Sponsor
- Investigators
- Anne Corbett, Study chair, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04373668
- Sponsor's protocol ID
- 1920/13
- Acronym
- NightCAP
- Status last verified
- Jul 2022
- First submitted
- 28 Apr 2020
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Hypnotic Drug Use and Improving Night-time Care for People Living With Dementia in Care Homes (NightCAP): A Randomised Factorial Trial
- ClinicalTrials.gov ID
- NCT04373668
- Acronym / sponsor ID
- NightCAP / 1920/13
- Conditions
- Dementia
- Keywords
- Dementia, Care Homes, Hypnotic Medication, Night Time Care, Behavioural symptoms, Cost effectiveness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- King's College London, University of East Anglia, Aston University
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 4 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control, optimised usual care | No intervention | –Treatment delivered as usual in the care home |
| Hypnotic Drug Review, Structured Sleep Hygiene and NightCAP | Experimental | Behavioral: Hypnotic Medication Review, Behavioral: Structured Sleep Hygiene, Behavioral: Night Time Care Activities ProgrammeCare homes to receive all three interventions: Hypnotic Drug Review, Structured Sleep Hygiene and NightCAP interventions |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypnotic Medication ReviewA training programme focused providing guidance on the review and withdrawal process of hypnotic drugs. | Behavioural | Hypnotic Drug Review, Structured Sleep Hygiene and NightCAP |
| Structured Sleep HygieneTraining module on the principle of good sleep hygiene | Behavioural | Hypnotic Drug Review, Structured Sleep Hygiene and NightCAP |
| Night Time Care Activities ProgrammeTraining 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 | Behavioural | Hypnotic Drug Review, Structured Sleep Hygiene and NightCAP |
Primary outcome
Sleep Disturbance Inventory SDI
Time frame: From baseline and immediately after intervention
Sleep disturbance behaviour as measured by the Sleep Disturbance Inventory SDI
11 secondary outcomes
Change of Hypnotic Drug Use
Time frame: From baseline, immediately after intervention and at four months follow-up
Dementia Quality of Life
Time frame: From baseline, immediately after intervention and at four months follow-up
Neuropsychiatric Inventory- Nursing Home (NPI-NH)
Time frame: From baseline, immediately after intervention and at four months follow-up
Cohen-Mansfield Agitation Inventory (CMAI)
Time frame: From baseline, immediately after intervention and at four months follow-up
Global Deterioration Scale (GDS)
Time frame: From baseline, immediately after intervention and at four months follow-up
Client Service Receipt Inventory (CSRI)
Time frame: From baseline, immediately after intervention and at four months follow-up
Functional Assessment Staging (FAST)
Time frame: From baseline, immediately after intervention and at four months follow-up
EQ5D-5L
Time frame: From baseline, immediately after intervention and at four months follow-up
Abbey Pain Scale
Time frame: From baseline, immediately after intervention and at four months follow-up
Approached to Dementia Questionnaire (ADQ)
Time frame: From baseline, immediately after intervention and at four months follow-up
Patient Health Questionnaire 9 (PHQ-9)
Time frame: From baseline, immediately after intervention and at four months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Dementia
RecruitingObservational study
PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
Aging
Active, not recruiting
The PorchLight Project
Memory Loss, Alzheimer Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Active, not recruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's Disease
Alzheimer Disease, Early Onset
Active, not recruiting
NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers
Dementia Caregivers, Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Corbett study chair
University of Exeter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnotic Medication Review, Structured Sleep Hygiene and Night Time Care Activities Programme in people with Dementia, run by University of Exeter at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kayleigh Nunez (01392724464, k.nunez@exeter.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Disturbance Inventory SDI (time frame: From baseline and immediately after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.