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

Evaluation of a multicomponent, non-pharmacological intervention to prevent and reduce sleep disturbances in nursing home residents with dementia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN36015309
Enrollment
360
Registered
2020-11-06
Start date
2021-03-01
Completion date
Unknown
Last updated
2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep disturbances in people with dementia living in nursing homes Mental and Behavioural Disorders

Interventions

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 perio

Sponsors

Institute of Social Medicine and Epidemiology, Nursing Research Unit
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Residents with a diagnosis of sleep-apnoea or REM-sleep behaviour disorder

Design outcomes

Primary

MeasureTime frame
Prevalence of at least two sleep disturbances in people with dementia, measured using the German version of the Sleep Disorder Inventory (SDI) after16 weeks

Secondary

MeasureTime frame
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 an

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 24, 2026