NightCAP: Reducing Hypnotic Drug Use & Improving Night-time Care

Status Recruiting

Clinical 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 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.

Clinical Trial 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

Related Conditions & MeSH terms

Dementia

Clinical Trial Details

NCT number	NCT04373668
Study type	Interventional
Source	University of Exeter
Contact	Kayleigh Nunez
Phone	01392724464
Email	k.nunez@exeter.ac.uk
Status	Recruiting
Phase	N/A
Start date	November 1, 2021
Completion date	April 30, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05686486` - Gentle Gymnastics and Relationship Between Family Caregivers and Residents With Dementia in Nursing Homes	N/A
Terminated	`NCT05451693` - Outreach-ER: A Dementia Care Intervention Program
Recruiting	`NCT05820919` - Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase	N/A
Enrolling by invitation	`NCT06040294` - Dementia and Disability Simulation for College Nursing Students' Senior Activity Facilitation Skills	N/A
Completed	`NCT05114187` - An Internet-Based Education Program for Care Partners of People Living With Dementia	N/A
Recruiting	`NCT06322121` - Vascular Aspects in Dementia: Part 2
Active, not recruiting	`NCT03676881` - Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
Completed	`NCT04426838` - Cognitive Behavioral Therapy for Insomnia for the Dementia Caregiving Dyad	N/A
Recruiting	`NCT03462485` - Pilot Study of the Effects of Playing Golf on People With Dementia	N/A
Active, not recruiting	`NCT03677284` - Managing Time With Dementia: Effects of Time Assistive Products in People With Dementia	N/A
Completed	`NCT03849937` - Changing Talk Online (CHATO) Study	N/A
Recruiting	`NCT06284213` - Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia Consortium
Recruiting	`NCT05579236` - Cortical Disarray Measurement in Mild Cognitive Impairment and Alzheimer's Disease
Completed	`NCT05080777` - Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems	N/A
Completed	`NCT04571697` - A Study of Comparing Rates of Dementia and Alzheimer's Disease in Participants Initiating Methotrexate Versus Those Initiating Anti-tumor Necrosis Factor (TNF)-Alpha Therapy
Completed	`NCT03583879` - Using Gait Robotics to Improve Symptoms of Parkinson's Disease	N/A
Recruiting	`NCT06033066` - Financial Incentives and Recruitment to the APT Webstudy	N/A
Active, not recruiting	`NCT05204940` - Longitudinal Observational Biomarker Study
Recruiting	`NCT05684783` - Dementia Champions in Homecare
Completed	`NCT03147222` - Function Focused Care: Fracture Care at Home	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms