Background
Objectives
Study design
Methods: participants, interventions and outcomes
Eligibility criteria
Cluster level
Resident level
Nurse level
Recruitment of clusters and study participants
Who will take informed consent?
Intervention
Intervention description
No. | What? Procedures | Why? Rationale and theory | What? Materials | How? Modes of delivery | Who? Intervention provider | When and how much? Number of sessions etc. |
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1. | Assessment of established sleep-promoting interventions and an appropriate environment in the participating nursing homes ▪ This assessment is based on interviews with the nursing staff (from night shifts) and a proxy assessment (via structured observations) of implemented interventions to promote the sleep of people with dementia. | ▪ Nursing homes are heterogeneous in terms of the existing prevalence of sleep problems and implemented interventions to avoid or reduce sleep problems [10, 33]. ▪ To ensure that the MoNoPol-Sleep intervention can be individually tailored to the needs of the participating nursing home, an assessment will be carried out. | ▪ Self-developed structured observation checklist and interview guide (which was already tested and adapted during the intervention development) ▪ Structured feedback as part of intervention component No. 3 | ▪ Observation on site (participating nursing home) and face to face interviews | ▪ Research staff | ▪ One proxy assessment (on site observation between 5 p.m. and 2 a.m.) and interviews with a minimum of four nurses (two day shift and two night shift) ▪ First week of the intervention phase |
2. | Implementation of two “sleep nurses” as change agents per nursing home. ▪ During the intervention phase, the sleep nurses (one nurse from the day shift and one nurse from the night shift) act as contact persons, multipliers, coordinators, change agents and as implementers of person-centered sleep promotion. ▪ For this purpose, the sleep nurses receive in-depth knowledge about sleep promotion, implementation strategies with regard to the MoNoPol-Sleep interventions and problem-solving strategies. ▪ In addition, the sleep nurses can reflect on their actions in coaching sessions and develop new problem-solving strategies. | ▪ Local praxis development champions are a crucial factor to implement person-centered care interventions [34, 35] ▪ Sleep nurses are important as contact persons, change agents and local champions. Such champions are recommended for the implementation of complex interventions [36]. | ▪ Written education material ▪ Written profile of the sleep nurses | ▪ Education sessions (both sleep nurses together for each nursing home) ▪ Coaching sessions (both sleep nurses together for each nursing home) | ▪ Research staff | ▪ Education: approx. Two hours of education as part of component No. 3 ▪ Coaching: approx. One hour after each workshop of the components No. 4 and 5 |
3. | Basic education course for nursing staff: “Sleep problems in dementia”. ▪ The education session is divided into three parts: ▪ Part 1 aims to provide information on the following topics: information on the background, course, schedule and responsibilities of the MoNoPol-Sleep trial, principles of person-centered care, sleep and sleep problems of people with dementia. Moreover, evidence-based information regarding six strategies to promote sleep of people with dementia will be presented. These strategies are: (1) Activation of people with dementia during the day, (2) Review and, if necessary, adjustment of the “going to bed routine”, (3) Review and, if necessary, adjustment of the night care (e.g. change of position routine), (4) Freedom from symptoms (e.g. with regard to thirst, pain, itching, anxiety), (5) Reflection of the appropriateness of sleep medication (6) Review and, if necessary, adjustment of the sleeping environment (e.g. light, sounds, temperature) ▪ The results of the assessment of established sleep-promoting interventions (component No. 1) will be presented in Part 2. ▪ Part 3 aims to provide information on the function and tasks of the new role of a sleep nurse (component No. 2) as change agent in each nursing home (intervention group). | ▪ Information regarding six strategies to promote sleep of people with dementia will be based on three reviews [23, 27, 37]. ▪ To give the nursing staff basic information about sleep problems in dementia as well as the schedule of the upcoming interventions. ▪ Sleep nurses need further information to fulfill their new role. | ▪ Written education material ▪ Information brochure (component No. 6) | ▪ Group session | ▪ Research staff | ▪ One session divided into three parts: ▪ Part 1 takes approx. 45 min, while Part 2 takes approx. 45 min and Part 3 lasts approx. Two hours ▪ Second week of intervention |
4. | Advanced education course for nursing staff: “Tailored problem solving” (two workshops). ▪ Two workshops which aim to support the implementation of person-centered sleep promotion and problem-solving competencies. ▪ In both workshops, one case of a resident with sleep problems from the facility will be discussed and solutions for improved sleep promotion sought. ▪ Each workshop contains the following seven steps: (1) Introduction, (2) Presentation of one resident as a case with sleep problems by the sleep nurse, (3) Prioritizing of care problems by all workshop participants, (4) Information about potential reasons for sleep problems by the moderating researcher, (5) Analysis of potential influencing factors for case-specific sleep problems by all workshop participants, (6) Formation of hypotheses for understanding, (7) Development and consensus on an action plan. | ▪ Based on a theory of change which was developed during the MoNoPol-Sleep intervention development: Sleep problems and their causes are individual for each person with dementia. ▪ Nursing home staff needs support in problem solving which take the available resources of people with dementia and the care environment into account. | ▪ Direction plan for the workshop ▪ Digital presentation ▪ Written education material ▪ Self-developed, standardized case analysis chart ▪ Moderator manual including e.g. list of causes for sleep problems, list of symptoms of sleep problems) | ▪ Group sessions | ▪ Research staff ▪ Sleep nurses | ▪ Both workshops take approx. 1.5 h each ▪ The first workshop will be held after component No. 3 and by the 6th week of intervention at the latest ▪ The second workshop will be held between the 7th and 12th week of intervention |
5. | Workshops: “Development of an institutional sleep-promoting concept” (two workshops with nursing management and sleep nurses). ▪ Two workshops aimed at the development and implementation of an organizational, specific action plan to promote sleep. ▪ The first workshop contains the following four steps: (1) Introduction, (2) Knowledge refreshment regarding the results of the assessment of established sleep-promoting interventions (component No. 1) and six strategies to promote sleep of people with dementia (see component No. 3), (3) Identification of organizational structures and processes which promote or hinder the sleep promotion, (4) Development and consensus on an action plan. ▪ The second workshop contains three steps: (1) Introduction, (2) Identification of organizational structures and processes which promote or hinder the implementation of the action plan (workshop 1), (3) Development and consensus on the implementation of the action plan. | ▪ Based on a theory of change which was developed during the MoNoPol-Sleep intervention development: Nursing homes are heterogeneous in terms of opportunities to provide person-centered sleep promotion. | ▪ Self-developed, standardized workshop protocol including resources for the moderator (e.g. action plan form) | ▪ Group sessions | ▪ Research staff ▪ Sleep nurses | ▪ Both workshops take approx. 2.5 h each ▪ The first workshop will be held after component No. 3 and by the 6th week of intervention at the latest ▪ The second workshop will be held between the 7th and 12th week of intervention |
6. | Written information and education material (e.g. brochure and “One Minute Wonder” poster). ▪ A series of eight “One Minute Wonder” posters addressing restful sleep, the identification of sleep problems and six strategies to promote sleep of people with dementia (see component No. 3). ▪ Two individual nursing home “One Minute Wonder” posters which will contain the nursing home’s specific action plan and its implementation (component No. 5). ▪ Information brochure which contains evidence-based information on sleep and sleep problems of people with dementia, six strategies to promote sleep of people with dementia (see component No. 3) and education material. | ▪ See components No. 1 to 5 | ▪ “One Minute Wonder” poster ▪ Information brochure | ▪ Not applicable | ▪ Research staff | ▪ Each ward of the participating nursing homes will receive the poster in weekly rhythm ▪ The first posters of the series are distributed on the wards after the basic education course (component No. 3) ▪ After completion of the basic education course, the staff of the nursing home will receive a brochure |
Explanation for the choice of comparators
Criteria for discontinuing or modifying allocated interventions
Strategies to improve adherence to interventions
Relevant concomitant care permitted or prohibited during the trial
Provisions for post-trial care
Outcomes
People with dementia | ||||
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Variable | Instrument | Source | Measurement points | Type of variable |
Demographic variables (e.g. documented sleep apnea, documented dementia diagnosis, Dementia Screening Scale, length of stay in nursing home) | Single items | Nursing records | T0 | Inclusion and exclusion criteria |
Demographic Variables (e.g. age, sex, care dependency levela) | Single items | Nursing records | T0 | Control variables |
Sleep Disorders | Sleep Disorder Inventory [32] | Retrospective rating by registered nurse (night shift)c | T0, T1, T2 | Primary outcome, Inclusion criterion |
Objective Sleep Measuresb | Actigraphy | T0, T2 | Secondary outcome | |
Quality of Sleep | Pittsburgh Sleep Quality Index [43] | Self-rating by participating people with dementiad | T0, T2 | Secondary outcome |
Daytime Sleepiness | Essener Questionaire of Age and Sleepiness in the Elderly (EFAS) [44] | Retrospective rating by registered nurse (day shift) | T0, T2 | Secondary outcome |
Quality of Life | Retrospective rating by registered nurse (night shift)c | T0, T2 | Secondary outcome | |
Agitation | Cohen-Mansfield Agitation Inventory [47] | Retrospective rating by registered nurse (day shift)b | T0, T2 | Secondary outcome |
Accidental falls | Single item | Nursing documentation | T1, T2 | Control variable |
Physical restraint use | Single item | Nursing documentation | T1, T2 | Control variable |
Psychotropic medication | Single items | Nursing documentation | T1, T2 | Control variable |
Staff | ||||
Variable | Instrument | Source | Measurement points | Type of variable |
Demographic variables (e.g. age, sex) | Single items | Staff questionnaire | T0 | Control variable |
Nurses sleep-related distress | Sleep Disorder Inventory [32] | Retrospective rating by registered nurse (night shift) | T0, T1, T2 | Secondary outcome |
Nurses distress caused by residents’ challenging behavior | Residents’ Challenging Behavior–related Distress Index [17] | Retrospective rating by registered nurse (day & night shift) | T0, T2 | Secondary outcome |
Cost analysis | ||||
Variable | Instrument | Source | Measurement points | Type of variable |
Costs related to the implementation of the intervention and the predefined outcomes | Self-developed cost protocol [48] | Documentation by trained external study assistants | Ongoing | Cost outcome |
Parameter | Material | Measurement points | Elements of process evaluation |
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Recruitment description | ▪ Documentation of the recruitment process ▪ Survey of reasons for participation (nursing home management/nursing service management) ▪ Survey of reasons for non-participation/withdrawal (nursing home management/nursing service management) | T0 | Recruitment |
Description of the context factors of the nursing homes | ▪ Existence of concepts or standards for dealing with sleep or promoting sleep (structured survey, nursing service management) | T0, T2 (only control group) | Description of the cluster (Context) |
▪ Culture in the nursing homes (Organizational Readiness for Implementing Change (ORIC)) [49]. ▪ Person-centered care (Person-centered climate questionnaire (staff version) (PCQ-S)) [50]. ▪ Team effort (Assessment of Interprofessional Team Collaboration Scale (AITCS)) [51]. ▪ Sample: nursing services and residential area managers, as well as 20% of all nursing staff per cluster | T0, T2 | ||
Implementation of the intervention components | ▪ Information about the needs assessment for each cluster (e.g. number of stakeholders involved, content) ▪ Number, frequency and content of the different components delivered to each cluster (including duration, number and function of participants, topics, necessary adjustments (type, reasons), deviations from the protocol), i.e.: ▪ Educational courses (basic and advanced) offered per cluster ▪ Workshops offered per cluster ▪ Training and support delivered to the change agents ▪ Other components offered | Implementation phase, T1, T2 (only intervention group) | Implementation of the intervention (Delivery) |
Adoption of the intervention components in the nursing homes | ▪ Content of the sleep-related care concept (document analysis) | T1, T2 | Implementation of the intervention (Response) |
▪ Number (rate) of participants attending the workshops per cluster (documentation) | Implementation phase | ||
▪ Number of workshops and internal training planned and carried out in the context of the intervention | T1, T2 | ||
▪ Changes in procedures and processes as a result of the interventions’ implementation (e.g. assessments) | T1, T2 | ||
Change processes in the nursing homes | ▪ Changes in procedures and processes due to the implementation of the sleep concept in each cluster (planned vs. implemented) | T1, T2 (only intervention group | |
▪ Changes regarding sleep promotion in the care plans of people with dementia (document analysis, n = 5 residents with sleep problems per cluster) | T2 (only intervention group) | ||
▪ Performance of care plans for sleep promotion (participating observations, 2 residents with sleep problems from selected nurses (2 per cluster)) | T2 (only intervention group) | ||
▪ Perception of changes in sleep promotion from people with dementia or their representatives, relatives or legal guardians (interviews, 4 per cluster) | T2 (only intervention group) | ||
Inhibiting / promoting factors and contextual conditions | ▪ Perspective of the target groups (managers, nurses actively involved in the intervention; interviews) | T2 (only intervention group) |
Primary outcome
Secondary outcomes
Process evaluation
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▪ Intervention components that are implemented by the research team in the nursing homes (delivery),
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▪ Change processes that are implemented in nursing homes as a result of the intervention and on the basis of the developed theory of change (response).
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▪ Characteristics of nursing homes and aspects of organizational culture (context).
Participant timeline
Sample size calculation
Assignment of interventions: allocation
Sequence generation
Concealment mechanism
Implementation
Assignment of interventions: blinding
Who will be blinded
Procedure for unblinding if neede
Data collection and management
Plans for assessment and collection of outcomes
Plans to promote participant retention and complete follow-up
Data management
Confidentiality
Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use
Statistical methods
Statistical methods for primary and secondary outcomes
Interim analyses
Methods for additional analyses (e.g. subgroup analysis)
Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data
Process evaluation
Oversight and monitoring
Composition of the coordinating center and trial steering committee
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▪ Prof. Dr. Sascha Köpke, Institute of Nursing Science, University of Cologne, Germany (Scientific coordinator)
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▪ Dr. Martin N. Dichter, Institute of Nursing Science, University of Cologne, Germany
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▪ Prof. Dr. Gabriele Meyer, Institute for Health and Nursing Science, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany
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▪ Dr. Almuth Berg, Institute for Health and Nursing Science, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany
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▪ Prof. Dr. Margareta Halek, German Center for Neurodegenerative Diseases (DZNE), Witten, Germany
Composition of the data monitoring committee, its role and reporting structure
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▪ Ms. Brigitte Bührlen, Munich, patient advocate, representative of “Wir pflegen! Stiftung pflegender Angehöriger” (self-help organization for people with dementia and/or their informal caregivers), Munich, Germany
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▪ Prof. Dr. med. Helmut Frohnhofen, geriatrician and sleep physician, University Hospital Düsseldorf, Düsseldorf, Germany
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▪ Mr. Thomas Peters, nursing home manager, Arbeiter Samariter Bund, “Norbert Burger nursing home”, Cologne, Germany
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▪ Dr. med. Tanja Richter, physician, legal guardian, health services researcher, University of Hamburg, Faculty of Mathematics, Informatics and Natural Sciences, Hamburg, Germany