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

NCT04373668 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 720

Last updated 2022-07-27

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • King's College London

    collaborator OTHER
  • University of East Anglia

    collaborator OTHER
  • Aston University

    collaborator OTHER
  • University of Exeter

    lead OTHER

Principal Investigators

  • Anne Corbett · University of Exeter

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2023-04-30
Completion
2023-04-30

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04373668 on ClinicalTrials.gov