NightCAP: Reducing Hypnotic Drug Use and Improving Night-time Care (NightCAP)

July 25, 2022 updated by: University of Exeter

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

720

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control, optimised usual care
Treatment delivered as usual in the care home
Experimental: Hypnotic Drug Review, Structured Sleep Hygiene and NightCAP
Care homes to receive all three interventions: Hypnotic Drug Review, Structured Sleep Hygiene and NightCAP interventions
Behavioral: Hypnotic Medication Review
A training programme focused providing guidance on the review and withdrawal process of hypnotic drugs.
Behavioral: Structured Sleep Hygiene
Training module on the principle of good sleep hygiene
Behavioral: Night Time Care Activities Programme
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Disturbance Inventory SDI
Time Frame: From baseline and immediately after intervention
Sleep disturbance behaviour as measured by the Sleep Disturbance Inventory SDI
From baseline and immediately after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Hypnotic Drug Use
Time Frame: From baseline, immediately after intervention and at four months follow-up
Hypnotic drug use assessed from the care home Medication Administration Record
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
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.
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
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.
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
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.
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
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.
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
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.
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
FAST is a proxy-rated instrument validated for use in people with dementia. It ascertains the severity of dementia in seven stages of functioning.
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
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).
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
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
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
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.
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
A measure of carer mental health and behaviour consisting of 9 questions
From baseline, immediately after intervention and at four months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Exeter

Collaborators

King's College London
University of East Anglia
Aston University

Investigators

  • Study Chair: Anne Corbett, University of Exeter

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Anticipated)

April 30, 2023

Study Completion (Anticipated)

April 30, 2023

Study Registration Dates

First Submitted

April 28, 2020

First Submitted That Met QC Criteria

April 30, 2020

First Posted (Actual)

May 4, 2020

Study Record Updates

Last Update Posted (Actual)

July 27, 2022

Last Update Submitted That Met QC Criteria

July 25, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1920/13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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