Qualitative sleep in nursing home residents
| ISRCTN | ISRCTN50844606 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50844606 |
- Submission date
- 26/08/2024
- Registration date
- 09/09/2024
- Last edited
- 09/09/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
One in three people in Belgium suffer from insomnia, half of the residents in residential care settings take benzodiazepines and one in three of the residents with dementia show nocturnal restlessness. Good sleep quality has a positive impact on people's quality of life. But how do you achieve this for residents in residential care settings that are as unique as their sleep problems? This study aims to transfer the scientific insights on cognitive behavioural therapy for insomnia in children (CBT-i) to the context of residential care centres.
Who can participate?
People living or working in a nursing home
What does the study involve?
The five components of CBT-i (sleep consolidation, sleep hygiene, stimulus control, cognitive restructuring and the application of relaxation techniques) will be applied to caregivers from residential care centers. It is expected that when their beliefs about sleep and insomnia change and when they consciously engage with stimulus control (eg turning on lights at night), practicing sleep hygiene in residents (eg no alcohol or coffee just before bedtime) and allowing the residents to 'relax', the residents' sleep quality will increase.
To investigate this, a cluster-allocated (at the level of the nursing home) study with pretest and posttest will be conducted with an intervention group (n=2 nursing homes) (CBT-i) and a control group (n=3 nursing homes) (standard care). Measurements will be taken by both employees and residents. After informed consent, a questionnaire with demographic data and beliefs and practices about sleep will be administered to the caregivers. These beliefs will partly be based on the Dysfunctional Beliefs about Sleep Questionnaire (DBAS) and partly on individual interviews that were held with caregivers in 2022-2023. In 25 items their beliefs about the reasons and consequences of insomnia, their concerns and their expectations of sleep and sleep medication are probed. In cognitively adequate residents, researchers take a questionnaire that gauges their quality of sleep (PSQI) end in cognitive inadequate residents two observers per resident fill in a behavioural observation scale that measures pain behaviour (Doloplus-2) and behavioural and mood changes such as nocturnal restlessness (Neuropsychiatric Inventory - NPI). Differences in scores will be calculated for both the staff and the residents. In addition, data on the use of psychotropic drugs will be collected. The hypothesis is that dysfunctional beliefs about sleep among caregivers will decrease (primary outcome), that residents' quality of sleep will increase and the use of benzodiazepines will decrease (secondary outcome).
What are the possible benefits and risks of participating?
There are no incentives for participating in this study. For residents whereby relaxation techniques will be applied, an evaluation of the effect is planned after eight weeks. In case of discomfort or other disadvantages of the relaxation techniques, the intervention will be stopped for that participant.
Where is the study run from?
University College Odisee
When is the study starting and how long is it expected to run for?
September 2023 to April 2026
Who is funding the study?
University College Odisee
Who is the main contact?
Katrin Gillis, katrin.gillis@odisee.be
Contact information
Public, Scientific, Principal Investigator
University College Odisee, Campus Sint-Niklaas, Hospitaalstraat 23
Sint-Niklaas
9100
Belgium
 ORCID ID |
0000-0002-2258-8285 |
|---|---|
| Phone | +32477967742 |
| katrin.gillis@odisee.be |
Study information
| Study design | Cluster randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Care home |
| Study type | Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Effectiveness of cognitive behaviour therapy for insomnia amongst professional caregivers on nursing home residents' quality of sleep |
| Study acronym | SLOP-NH |
| Study objectives | Cognitive behavioural therapy for insomnia amongst caregivers in nursing home might increase the sleep quality of residents. |
| Ethics approval(s) |
Approved 18/12/2023, Committee of Ethics Antwerp University Hospital (Drie Eikenstraat 655, Edegem, 2650, Belgium; +3238213000; ethisch.comite@uza.be), ref: B3002023000194 |
| Health condition(s) or problem(s) studied | Treatment of older adults in nursing homes with bad sleep quality or nocturnal unrest |
| Intervention | Caregivers (nurses and nurse assistants) will be cluster-randomised using a computer to receive cognitive behavioural therapy whereby they will receive education to change their beliefs in sleep and training on non-pharmacological interventions to provide relaxation moments to residents. On a team level, every team in the intervention group have to make an appointment to regulate better sleep hygiene and reduce sleep deprivation stimuli. The sleep situation of residents with 'worse' sleep will be analyzed by an interdisciplinary team to provide a tailored relaxation program for these residents. |
| Intervention type | Behavioural |
| Primary outcome measure | Sleep beliefs of caregivers measured using the Dysfunctional Beliefs and Attitudes about Sleep scale at baseline and after eight months |
| Secondary outcome measures | 1. The sleep quality of residents measured using the Pittsburgh Sleep Quality Index for Cognitively Adequate residents and the Neuropsychiatric Inventory and Doloplus-2 for cognitively impaired residents at baseline and after one year 2. Use of benzodiazepines and other psychotropics measured using electronic medication files at baseline and after one year |
| Overall study start date | 15/09/2023 |
| Completion date | 01/04/2026 |
Eligibility
| Participant type(s) | Health professional, Resident |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 110 Years |
| Sex | Both |
| Target number of participants | 300 residents and 150 caregivers |
| Key inclusion criteria | People living or working in a nursing home |
| Key exclusion criteria | Not meeting the participant inclusion criteria |
| Date of first enrolment | 01/02/2024 |
| Date of final enrolment | 01/02/2026 |
Locations
Countries of recruitment
- Belgium
Study participating centres
Dentergem
8720
Belgium
Ruiselede
8755
Belgium
Kieldrecht
9130
Belgium
Zoersel
2980
Belgium
Sint-Niklaas
9100
Belgium
Sponsor information
University/education
Warmoesberg 26
Brussels
1000
Belgium
| Phone | +32 486 49 74 71 |
|---|---|
| dirk.smits@odisee.be | |
| Website | https://www.odisee.be/ |
"ROR" |
https://ror.org/02c89h825 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 30/09/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in an international peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Katrin Gillis (katrin.gillis@odisee.be). • The type of data that will be shared: excel file with raw data ‘demographics, DBAS, NPI and Doloplus2, PSQI • Timing for availability: after publication of the study manuscript (estimated end of 2025) • Whether consent from participants was required and obtained: yes • Comments on data anonymization: all data will be anonymised • Any ethical or legal restrictions; none • Any additional comments: none |
Editorial Notes
27/08/2024: Study's existence confirmed by the Committee of Ethics Antwerp University Hospital.
