Evaluation of an intervention to prevent and reduce sleep disturbances in nursing home residents with dementia

ISRCTN	ISRCTN36015309
DOI	https://doi.org/10.1186/ISRCTN36015309
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	Institute of Social Medicine and Epidemiology, Nursing Research Unit
Funder	Bundesministerium für Bildung und Forschung

Submission date: 27/10/2020
Registration date: 06/11/2020
Last edited: 05/03/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Dementia is a syndrome (a group of related symptoms) associated with an ongoing decline of brain functioning. Sleep disturbances are common in people with dementia. The current state of research shows that drug therapy cannot be recommended. The aim of this study is to pilot and evaluate the effects of a newly developed complex nursing intervention to prevent and reduce sleep problems in people with dementia living in nursing homes.

Who can participate?
Nursing homes with at least 50 residents and sufficient resources (staff and time) to conduct the study.
Residents with dementia who have lived in the participating nursing homes for at least two weeks and nurses with at least a half time position and at least three night shifts in the last three months.

What does the study involve?
Nursing homes will be randomly allocated to one of two groups. Each group will be assigned to 12 nursing homes with 180 residents with dementia. The intervention consists of six components:
1. Assessment of established sleep-promoting interventions in the participating nursing homes
2. Basic education course for nursing staff: “Sleep problems in dementia”
3. Advanced education course for nursing staff: “Tailored problem solving” (two workshops)
4. Workshops: “Development of an institutional sleep-promoting concept” (two workshops with nursing management and sleep nurses)
5. Written information and education material (e.g. brochure and “One Minute Wonder” poster)
6. Implementation of two “sleep nurses” as change agents per nursing home
The intervention will be performed over a period of 16 weeks.
The intervention will be compared to usual care in the control group over a period of 16 weeks. Sleep prevalence will be measured at the start of the study and after 8 and 16 weeks.

What are the possible benefits and risks of participating?
Participants in the intervention group may benefit from the study as it aims to decrease the prevalence of sleep problems. Also, the study will extend the understanding of the effects of the newly developed intervention. There will be no risk of participating for residents with dementia and/or nurses.

Where is the study run from?
University of Lübeck (Germany)

When is the study starting and how long is it expected to run for?
October 2018 to March 2022

Who is funding the study?
German Federal Ministry of Education and Research

Who is the main contact?
Prof. Dr. Sascha Köpke
Sascha.Koepke@uk-koeln.de

Contact information

Prof Sascha Köpke
Scientific

Gleueler Straße 176-178
Cologne
50935
Germany

ORCID ID	0000-0003-4106-4919
Phone	+49 (0)221 478-51658
Email	Sascha.Koepke@uk-koeln.de

Study information

Primary study design	Interventional
Study design	Multicentre interventional cluster-randomized controlled trial
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
Scientific title	Evaluation of a multicomponent, non-pharmacological intervention to prevent and reduce sleep disturbances in nursing home residents with dementia
Study acronym	MoNoPol-Sleep
Study objectives	The study aims at applying a multi-modal, non-pharmacological intervention to avoid sleep disturbances in people with dementia living in nursing homes and reduce caregiver distress
Ethics approval(s)	Approved 06/08/2020, Ethics Committee of German Society of Nursing Science (Stockumer Str. 12, 58453 Witten, Germany; +49 203 356793; Ethikkommission@dg-pflegewissenschaft.de), ref: 20-016
Health condition(s) or problem(s) studied	Sleep disturbances in people with dementia living in nursing homes
Intervention	The trial is a parallel group cluster-randomized controlled trial. The intervention group receive a complex nursing intervention which consists of six components which will be implemented over a period of 16 weeks with the support of the research team. The intervention components are: 1. Assessment of established sleep-promoting interventions in the participating nursing homes 2. Basic education course for nursing staff: “Sleep problems in dementia” 3. Advanced education course for nursing staff: “Tailored problem solving” (two workshops) 4. Workshops: “Development of an institutional sleep-promoting concept” (two workshops with nursing management and sleep nurses) 5. Written information and education material (e.g. brochure and “One Minute Wonder” poster) 6. Implementation of two “sleep nurses” as change agents per nursing home The control group receives usual care. Randomization will be carried out on a cluster level. The randomization list will be computer-generated by an independent external biostatistician, who will be blinded to the identity of the participating organizations and people with dementia. Nursing homes will be allocated to the intervention or control group using balanced randomization using blocks, stratified by the three study centers: Halle (Saale), Lübeck and Witten, as well as the time point of the recruiting phase.
Intervention type	Behavioural
Primary outcome measure(s)	Prevalence of at least two sleep disturbances in people with dementia, measured using the German version of the Sleep Disorder Inventory (SDI) after16 weeks
Key secondary outcome measure(s)	Measured at baseline and 16 weeks (unless otherwise noted): Resident level: 1. Frequency and severity of sleep disturbances. Sleep disturbances are defined based on the items of the German version of the Sleep Disorders Inventory (SDI) 2. Quality of sleep. Quality of sleep is defined based on the German version of the Pittsburgh Sleep Quality Index (PSQI) 3. Objective measurement of sleep quality and sleep problems based on actigraphy (subsample at the Lübeck study center) 4. Daily sleepiness. The Essener Questionnaire Age and Sleepiness (EFAS) is used to determine the level of daytime sleepiness 5. Quality of life. Quality of life is assessed using the German version of the QUALIDEM instrument rated by nurses. 6. Agitation. Agitated behavior of the participating people with dementia is rated by nurses using the Cohen Mansfield Agitation Inventory (CMAI) 7. Adverse events after 16 weeks of follow-up. Adverse events include falls, physical restraints and psychotropic medication. Data collection is based on the nursing documentation into their own data extraction tables Caregiver level: 1. Burden caused by sleep problems of people with dementia. Burden will be assessed with the SDI 2. Burden caused by challenging behaviour of people with dementia. Burden will be assessed applying the 9-item Residents ’ challenging behaviour-related distress index Organisational level: Cost evaluation is carried out throughout the project. A self-developed data entry form is used for cost evaluation. Process-related outcomes: Process-related outcomes are assessed ongoing. The process evaluation is carried out according to the MRC framework on process evaluations for complex interventions and is structured into three components: 1. Intervention components implemented by the research team in the facilities (delivery) 2. Change processes that are implemented in the facilities based on the intervention and on the basis of the developed theory of change (response) 3. Characteristics and aspects of the culture in facilities (context)
Completion date	31/03/2022

Eligibility

Participant type(s)	Mixed
Age group	Mixed
Sex	All
Target sample size at registration	360
Key inclusion criteria	Nursing homes 1. Nursing homes with at least 50 residents will be eligible 2. Nursing homes must indicate sufficient resources (staff and time) to conduct the study Residents 1. Documented dementia diagnosis or a score ≥3 on the Dementia Screening Scale (DSS). 2. At least two sleep problems according to the Sleep Disorder Inventory (SDI) 3. Length of stay ≥ 2 weeks in the nursing home Nurses 1. Work on at least a 50% contract (approx. 19 - 20 hours/week) 2. Worked at least three night shifts during the three months prior to data collection
Key exclusion criteria	Residents with a diagnosis of sleep-apnoea or REM-sleep behaviour disorder
Date of first enrolment	01/03/2021
Date of final enrolment	15/04/2021

Locations

Countries of recruitment

Germany

Study participating centres

University of Lübeck

Institute of Social Medicine and Epidemiology, Nursing Research Unit
Ratzeburger Allee 160
Lübeck
23562
Germany

German Center for Neurodegenerative Diseases (DZNE)

Stockumer Str. 12
Witten
58453
Germany

Martin Luther University Halle-Wittenberg Institute for Health and Nursing Science

Magdeburger Straße 8
Halle (Saale)
06112
Germany

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during the study will be available on reasonable request.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		08/01/2024	16/01/2024	Yes	No
Protocol article		12/01/2021	10/08/2022	Yes	No
Other publications		03/03/2025	05/03/2025	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

05/03/2025: Publication reference added.
16/01/2024: Publication reference added.
16/01/2023: The intention to publish date has been changed from 31/07/2022 to 31/07/2023.
10/08/2022: Publication reference added.
17/12/2021: The following changes were made to the trial record:
1. The overall end date was changed from 28/02/2022 to 31/03/2022.
2. The intention to publish date was changed from 30/04/2022 to 31/07/2022.
3. The plain English summary was updated to reflect these changes.
16/12/2021: The following changes were made to the trial record:
1. The overall end date was changed from 30/09/2021 to 28/02/2022.
2. The intention to publish date was changed from 31/12/2021 to 30/04/2022.
3. The plain English summary was updated to reflect these changes.
09/11/2020: The target number of participants was changed from 24 nursing homes (approximately 480 people with dementia) to 24 nursing homes (approximately 360 people with dementia).
02/11/2020: Trial’s existence confirmed by the Ethics Committee of the German Nursing Society.