Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on sleep in brain health

LIVE: Thursday 2nd May 2024, 18:00-19:30 (CEST)

Quality sleep is essential for health. But what happens to our brains when sleep patterns are disturbed? Join our experts to explore the interplay between sleep disruption and neurological diseases, and the questions that you need to be asking your patients to help you prevent the harmful effects of sleep deprivation.
ADVANCED SEARCH
Log in
Top
BMC Geriatrics
Published in: BMC Geriatrics 1/2021

01-12-2021 | Care | Study protocol

Evaluation of a multi-component, non-pharmacological intervention to prevent and reduce sleep disturbances in people with dementia living in nursing homes (MoNoPol-sleep): study protocol for a cluster-randomized exploratory trial

Authors: Martin N. Dichter, Almuth Berg, Jonas Hylla, Daniela Eggers, Denise Wilfling, Ralph Möhler, Burkhard Haastert, Gabriele Meyer, Margareta Halek, Sascha Köpke

Published in: BMC Geriatrics | Issue 1/2021

Login to get access

Abstract

Background

Sleep problems are highly prevalent in people with dementia. Nevertheless, there is no “gold standard” intervention to prevent or reduce sleep problems in people with dementia. Existing interventions are characterized by a pronounced heterogeneity as well as insufficient knowledge about the possibilities and challenges of implementation. The aim of this study is to pilot and evaluate the effectiveness of a newly developed complex intervention to prevent and reduce sleep problems in people with dementia living in nursing homes.

Methods

This study is a parallel group cluster-randomized controlled trial. The intervention consists of six components: (1) the assessment of established sleep-promoting interventions and an appropriate environment in the participating nursing homes, (2) the implementation of two “sleep nurses” as change agents per nursing home, (3) a basic education course for nursing staff: “Sleep problems in dementia”, (4) an advanced education course for nursing staff: “Tailored problem-solving” (two workshops), (5) workshops: “Development of an institutional sleep-promoting concept” (two workshops with nursing management and sleep nurses) and (6) written information and education material (e.g. brochure and “One Minute Wonder” poster). The intervention will be performed over a period of 16 weeks and compared with usual care in the control group.
Overall, 24 nursing homes in North, East and West Germany will be included and randomized in a 1:1 ratio. The primary outcome is the prevalence of sleep problems in people with dementia living in nursing homes. Secondary outcomes are quality of life, quality of sleep, daytime sleepiness and agitated behavior of people with dementia, as well as safety parameters like psychotropic medication, falls and physical restraints. The outcomes will be assessed using a mix of instruments based on self- and proxy-rating. A cost analysis and a process evaluation will be performed in conjunction with the study.

Conclusions

It is expected that the intervention will reduce the prevalence of sleep problems in people with dementia, thus not only improving the quality of life for people with dementia, but also relieving the burden on nursing staff caused by sleep problems.

Trial registration

Current controlled trials: ISRCTN36015309. Date of registration: 06/11/2020.
Literature
1.
RKI. Gesundheit in Deutschland. Gesundheitsberichterstattung des Bundes. Gemeinsam getragen von RKI und Destatis. Berlin: Robert-Koch-Institut; 2015.
2.
Ziegler U, Doblhammer G. Prevalence and incidence of dementia in Germany--a study based on data from the public sick funds in 2002. Gesundheitswesen (Bundesverband der Arzte des Offentlichen Gesundheitsdienstes (Germany)). 2009;71(5):281–90.CrossRef
3.
Doblhammer G, Fink A, Fritze T. Short-term trends in dementia prevalence in Germany between the years 2007 and 2009. Alzheimer’s Dementia. 2015;11(3):291–9.PubMedCrossRef
4.
5.
Yesavage JA, Friedman L, Ancoli-Israel S, Bliwise D, Singer C, Vitiello MV, Monjan AA, Lebowitz B. Development of diagnostic criteria for defining sleep disturbance in Alzheimer's disease. J Geriatric Psychiatry Neurol. 2003;16(3):131–9.CrossRef
6.
Fung CH, Martin JL, Chung C, Fiorentino L, Mitchell M, Josephson KR, Jouldjian S, Alessi C. Sleep disturbance among older adults in assisted living facilities. Am J Geriatr Psychiatry. 2012;20(6):485–93.PubMedPubMedCentralCrossRef
7.
Neikrug AB, Ancoli-Israel S. Sleep disturbances in nursing homes. J Nutr Health Aging. 2010;14(3):207–11.PubMedCrossRef
8.
Fung CH, Vitiello MV, Alessi CA, Kuchel GA. Report and Research Agenda of the American Geriatrics Society and National Institute on Aging Bedside-to-Bench Conference on Sleep, Circadian Rhythms, and Aging: New Avenues for Improving Brain Health, Physical Health, and Functioning. J Am Geriatr Soc. 2016;64(12):e238–47.PubMedPubMedCentralCrossRef
9.
Smagula SF, Stone KL, Fabio A, Cauley JA. Risk factors for sleep disturbances in older adults: Evidence from prospective studies. Sleep Med Rev. 2016;25:21–30.PubMedCrossRef
10.
Wilfling D, Dichter MN, Trutschel D, Kopke S. Prevalence of Sleep Disturbances in German Nursing Home Residents with Dementia: A Multicenter Cross-Sectional Study. J Alzheimers Dis. 2019;69(1):227–36.PubMedCrossRef
11.
Webster L, Costafreda Gonzalez S, Stringer A, Lineham A, Budgett J, Kyle S, Barber J, Livingston G. Measuring the prevalence of sleep disturbances in people with dementia living in care homes: a systematic review and meta-analysis. Sleep. 2020;43(4). https://​doi.​org/​10.​1093/​sleep/​zsz251.
12.
Uchmanowicz I, Markiewicz K, Uchmanowicz B, Kołtuniuk A, Rosińczuk J. The relationship between sleep disturbances and quality of life in elderly patients with hypertension. Clin Interv Aging. 2019;14:155–65.PubMedPubMedCentralCrossRef
13.
Zhang H, Li Y, Zhao X, Mao Z, Abdulai T, Liu X, Tu R, Wang Y, Qian X, Jiang J, et al. The association between PSQI score and hypertension in a Chinese rural population: the Henan Rural Cohort Study. Sleep Med. 2019;58:27–34.PubMedCrossRef
14.
Cipriani G, Lucetti C, Danti S, Nuti A. Sleep disturbances and dementia. Psychogeriatrics. 2015;15(1):65–74.PubMedCrossRef
15.
Wilfling D, Dichter MN, Trutschel D, Kopke S. Nurses’ burden caused by sleep disturbances of nursing home residents with dementia: multicenter cross-sectional study. BMC Nurs. 2020;19:83.PubMedPubMedCentralCrossRef
16.
Bird M, Anderson K, MacPherson S, Blair A. Do interventions with staff in long-term residential facilities improve quality of care or quality for life people with dementia? A systematic review of the evidence. Int Psychogeriatr. 2016;28(12):1937–63.PubMedCrossRef
17.
Schmidt SG, Dichter MN, Palm R, Hasselhorn HM. Distress experienced by nurses in response to the challenging behaviour of residents - evidence from German nursing homes. J Clin Nurs. 2012;21(21–22):3134–42.PubMedCrossRef
18.
McPherson S, Hiskey S, Alderson Z. Distress in working on dementia wards - A threat to compassionate care: A grounded theory study. Int J Nurs Stud. 2016;53:95–104.PubMedCrossRef
19.
Aasmul I, Husebo BS, Flo E. Staff Distress Improves by Treating Pain in Nursing Home Patients With Dementia: Results From a Cluster-Randomized Controlled Trial. J Pain Symptom Management. 2016;52(6):795–805.CrossRef
20.
Maust DT, Langa KM, Blow FC, Kales HC. Psychotropic use and associated neuropsychiatric symptoms among patients with dementia in the USA. Int J Geriatr Psychiatry. 2017;32(2):164–74.PubMedCrossRef
21.
Berry SD, Lee Y, Cai S, Dore DD. Nonbenzodiazepine sleep medication use and hip fractures in nursing home residents. JAMA Int Med. 2013;173(9):754–61.CrossRef
22.
Saarelainen L, Tolppanen AM, Koponen M, Tanskanen A, Sund R, Tiihonen J, Hartikainen S, Taipale H. Risk of Hip Fracture in Benzodiazepine Users With and Without Alzheimer Disease. J Am Med Directors Assoc. 2017;18(1):87.e15–21.CrossRef
23.
McCleery J, Cohen DA, Sharpley AL. Pharmacotherapies for sleep disturbances in dementia. Cochrane Database Syst Rev. 2016;11:Cd009178.PubMed
24.
Wilfling D, Junghans A, Marshall L, Eisemann N, Meyer G, Möhler R, Köpke S. Non-pharmacological interventions for sleep disturbances in people with dementia. Cochrane Database Syst Rev. 2015;(9).
25.
Craig P, Petticrew M. Developing and evaluating complex interventions: reflections on the 2008 MRC guidance. Int J Nurs Stud. 2013;50(5):585–7.PubMedCrossRef
26.
Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Medical Research Council G: Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ (Clinical research ed). 2008;337:a1655.
27.
Wilfling D, Hylla J, Berg A, Meyer G, Köpke S, Halek M, Möhler R, Dichter MN: Characteristics of multi-component, non-pharmacological interventions to reduce or avoid sleep disturbances in nursing home res-idents: A systematic review. International Psychogeriatrics 2020:XXX.
28.
Dichter MN, Hylla J, Berg A, Eggers D, Möhler R, Meyer G, Köpke S, Halek M. Development of a Theory of Change as a basis for an intervention to reduce sleep problems in people with dementia in nursing homes. In: 21 Annual Meeting German Evidence based Medicine Network 2020: 13. - 15.02.2020; University of Basel; 2020.
29.
Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, Moore L, O'Cathain A, Tinati T, Wight D, et al. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015;350:h1258.PubMedPubMedCentralCrossRef
30.
Grant A, Treweek S, Dreischulte T, Foy R, Guthrie B. Process evaluations for cluster-randomised trials of complex interventions: a proposed framework for design and reporting. Trials. 2013;14:15.PubMedPubMedCentralCrossRef
31.
Köhler L, Weyerer S, Schäufele M. Proxy screening tools improve the recognition of dementia in old-age homes: results of a validation study. Age Ageing. 2007;36(5):549–54.PubMedCrossRef
32.
Tractenberg RE, Singer CM, Cummings JL, Thal LJ. The Sleep Disorders Inventory: an instrument for studies of sleep disturbance in persons with Alzheimer's disease. J Sleep Res. 2003;12(4):331–7.PubMedPubMedCentralCrossRef
33.
Webster L, Powell K, Costafreda SG, Livingston G. The impact of sleep disturbances on care home residents with dementia: the SIESTA qualitative study. Int Psychogeriatr. 2020:1–9.
34.
Quasdorf T, Riesner C, Dichter MN, Dortmann O, Bartholomeyczik S, Halek M. Implementing Dementia Care Mapping to develop person-centred care: results of a process evaluation within the Leben-QD II trial. J Clin Nurs. 2017;26(5–6):751–65.PubMedCrossRef
35.
Santana MJ, Manalili K, Jolley RJ, Zelinsky S, Quan H, Lu M. How to practice person-centred care: A conceptual framework. Health Expect. 2018;21(2):429–40.PubMedCrossRef
36.
Groot Kormelinck CM, Janus SIM, Smalbrugge M, Gerritsen DL, Zuidema SU. Systematic review on barriers and facilitators of complex interventions for residents with dementia in long-term care. Int Psychogeriatr. 2020:1–17.
37.
Capezuti E, Sagha Zadeh R, Pain K, Basara A, Jiang NZ, Krieger AC. A systematic review of non-pharmacological interventions to improve nighttime sleep among residents of long-term care settings. BMC Geriatr. 2018;18(1):143.PubMedPubMedCentralCrossRef
38.
Halek M, Reuther S, Muller-Widmer R, Trutschel D, Holle D. Dealing with the behaviour of residents with dementia that challenges: A stepped-wedge cluster randomized trial of two types of dementia-specific case conferences in nursing homes (FallDem). Int J Nurs Stud. 2020;104:103435.PubMedCrossRef
39.
Lichtwarck B, Myhre J, Selbaek G, Kirkevold O, Rokstad AMM, Benth JS, Bergh S. TIME to reduce agitation in persons with dementia in nursing homes. A process evaluation of a complex intervention. BMC Health Serv Res. 2019;19(1):349.PubMedPubMedCentralCrossRef
40.
Reuther S, Dichter MN, Buscher I, Vollmar HC, Holle D, Bartholomeyczik S, Halek M. Case conferences as interventions dealing with the challenging behavior of people with dementia in nursing homes: a systematic review. Int Psychogeriatr. 2012;24(12):1891–903.PubMedCrossRef
41.
Lüdtke S, Hein A, Krüger F, Bader S, Kirste T. Actigraphic Sleep Detection for Real-World Data of Healthy Young Adults and People with Alzheimer's Disease. In: BIOSIGNALS; 2017. p. 185–92.
42.
Hein A, Krüger F, Bader S, Eschholz P, Kirste T. Challenges of collecting empirical sensor data from people with dementia in a field study. In: 2017 IEEE International Conference on Pervasive Computing and Communications Workshops (PerCom Workshops): IEEE; 2017. p. 22–5.
43.
Buysse DJ, Reynolds CF, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: A New Instrument for Psychiatric Practice and Research. Psychiatry Res. 1988;28:193–213.CrossRef
44.
Frohnhofen H, Bibl M, Nickel B, Popp R. Der essener Fragebogen Alter und Schläfrigkeit (EFAS) - ein neues Assessmentinstrument zur Messung von Tagschläfrigkeit bei alten Menschen. Eur J Geriatr. 2010;12(2):84–90.
45.
Dichter MN, Ettema TP, Schwab CGG, Meyer G, Bartholomeyczik S, Halek M, Dröes RM. QUALIDEM - User Guide. In: Witten; 2016.
46.
Ettema TP, Dröes RM, de Lange J, Mellenbergh GJ, Ribbe MW. QUALIDEM: development and evaluation of a dementia specific quality of life instrument. Scalability, reliability and internal structure. Int J Geriatr Psychiatr. 2007;22(6):549–56.CrossRef
47.
Cohen-Mansfield J, Marx MS, Rosenthal AS. A description of agitation in a nursing home. J Gerontol. 1989;44(3):M77–84.PubMedCrossRef
48.
Richter C, Berg A, Langner H, Meyer G, Köpke S, Balzer K, Wolschon E, Silies K, Soönnichsen A, Löscher S, et al. Effect of person-centred care on antipsychotic drug use in nursing homes (EPCentCare): a cluster-randomised controlled trial. Age Ageing. 2019;48(3):419-425.
49.
Shea CM, Jacobs SR, Esserman DA, Bruce K, Weiner BJ. Organizational readiness for implementing change: a psychometric assessment of a new measure. Implement Sci. 2014;9:7.PubMedPubMedCentralCrossRef
50.
Edvardsson D, Koch S, Nay R. Psychometric evaluation of the English language Person-centred Climate Questionnaire--staff version. J Nurs Manag. 2010;18(1):54-60.
51.
Orchard C, Pederson LL, Read E, Mahler C, Laschinger H. Assessment of Interprofessional Team Collaboration Scale (AITCS): Further Testing and Instrument Revision. J Contin Educ Health Prof. 2018;38(1):11–8.PubMedCrossRef
52.
Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine. 2000;25(24):3186–91.PubMedCrossRef
53.
Smith MT, McCrae CS, Cheung J, Martin JL, Harrod CG, Heald JL, Carden KA. Use of Actigraphy for the Evaluation of Sleep Disorders and Circadian Rhythm Sleep-Wake Disorders: An American Academy of Sleep Medicine Clinical Practice Guideline. J Clin Sleep Med. 2018;14(7):1231–7.PubMedPubMedCentralCrossRef
54.
Frohnhofen H, Bibl M, Nickel B, Popp R. The Essen questionnaire on age and sleepiness – a new assessment tool to measure daytime sleepiness in elderly people. Eur J Geriatr. 2010;12(2):84–90.
55.
Dichter MN, Schwab CG, Meyer G, Bartholomeyczik S, Halek M. Item distribution, internal consistency and inter-rater reliability of the German version of the QUALIDEM for people with mild to severe and very severe dementia. BMC Geriatr. 2016;16:126.PubMedPubMedCentralCrossRef
56.
Cohen-Mansfield J. Instruction Manual for the Cohen-Mansfield Agitation Inventory (CMAI). Maryland: Rockville; 1991.
57.
Hülser K. Klinische Diagnostik im Rahmen der Qualitätssicherung. Ruhr-Universität Bochum; 2001.
58.
Abraham J, Kupfer R, Behncke A, Berger-Hoger B, Icks A, Haastert B, Meyer G, Kopke S, Mohler R. Implementation of a multicomponent intervention to prevent physical restraints in nursing homes (IMPRINT): A pragmatic cluster randomized controlled trial. Int J Nurs Stud. 2019;96:27–34.PubMedCrossRef
59.
Donner A, Klar N. Design and Analysis of Cluster Randomization Trials in Health Research; 2000.
60.
61.
Dixon JR. The International Conference On Harmonization Good Clinical Ppractice Guideline. Qual Assurance. 1999;6(2):65–74.CrossRef
62.
Mayring P. Qualitative inhaltsanalyse. In: Handbuch qualitative Forschung in der Psychologie: Springer; 2010. p. 601–13.
63.
Verbeek H, Meyer G, Leino-Kilpi H, Zabalegui A, Hallberg IR, Saks K, Soto ME, Challis D, Sauerland D, Hamers JP, et al. A European study investigating patterns of transition from home care towards institutional dementia care: the protocol of a RightTimePlaceCare study. BMC Public Health. 2012;12:68.PubMedPubMedCentralCrossRef
64.
65.
Campbell MK, Piaggio G, Elbourne DR, Altman DG, Group C. Consort 2010 statement: extension to cluster randomised trials. BMJ 2012;345:e5661.
66.
Möhler R, Köpke S, Meyer G. Criteria for Reporting the Development and Evaluation of Complex Interventions in healthcare: revised guideline (CReDECI 2). Trials. 2015;16:204.PubMedPubMedCentralCrossRef
67.
McKeown J, Clarke A, Ingleton C, Repper J. Actively involving people with dementia in qualitative research. J Clin Nurs. 2010;19(13–14):1935–43.PubMed
68.
Schnell MW, Heinritz C. Forschungsethik: ein Grundlagen-und Arbeitsbuch mit Beispielen aus der Gesundheits-und Pflegewissenschaft: Huber; 2006.
69.
Dewing J. Participatory research: a method for process consent with persons who have dementia. Dementia. 2007;6(1):11–25.CrossRef
Metadata
Title
Evaluation of a multi-component, non-pharmacological intervention to prevent and reduce sleep disturbances in people with dementia living in nursing homes (MoNoPol-sleep): study protocol for a cluster-randomized exploratory trial
Authors
Martin N. Dichter
Almuth Berg
Jonas Hylla
Daniela Eggers
Denise Wilfling
Ralph Möhler
Burkhard Haastert
Gabriele Meyer
Margareta Halek
Sascha Köpke
Publication date
01-12-2021
Publisher
BioMed Central
Published in
BMC Geriatrics / Issue 1/2021
Electronic ISSN: 1471-2318
DOI
https://doi.org/10.1186/s12877-020-01997-8

Other articles of this Issue 1/2021

BMC Geriatrics 1/2021 Go to the issue

Research article

The adaptation of older adults’ transition to residential care facilities and cultural factors: a meta-synthesis

Research

Potentially inappropriate medication use among older adult patients on follow-up at the chronic care clinic of a specialized teaching hospital in Ethiopia. A cross-sectional study

Study protocol

Developing and evaluating online COVID-centric advance care planning training and information resources for nursing staff and family members in nursing homes: the necessary discussions study protocol

Research article

Incidence and multidimensional predictors of occasional and recurrent falls among Malaysian community‐dwelling older persons

Research

Does the combination of resistance training and a nutritional intervention have a synergic effect on muscle mass, strength, and physical function in older adults? A systematic review and meta-analysis

Research

Knowledge, attitude and practice of dentists toward providing care to the geriatric patients

ACC 2024 Congress Coverage

Heart Failure Video

Year in Review: Heart failure and cardiomyopathies

Watch now

Watch this official video from ACC.24 to hear Dr. Biykem Bozkurt discuss last year's major advances in heart failure and cardiomyopathies.

Semaglutide benefits people with type 2 diabetes and obesity-related heart failure

16-04-2024 Type 2 Diabetes News

Incentivised to exercise

11-04-2024 Lifestyle Modifications News

New intervention for STEMI-related cardiogenic shock

10-04-2024 Myocardial Infarction News

» View more highlights on the ACC 2024 congress hub page

Image Credits