Table 2.
Outcome instruments
| People with dementia | ||||
|---|---|---|---|---|
| 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 | Algorithm to analyze actigraphic data with respect to sleep patterns [41, 42] | 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 | QUALIDEM 2.0 [45, 46] | 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 |
aCare levels based on the assessment of the experts of the medical service of the health insurance funds
bOnly subgroup of eight nursing homes of the Lübeck Study Centre
cRetrospective assessment (of the last 2 weeks before data collection) by nursing professionals. Here, the nursing professionals are instructed by a member of the scientific team
dSelf-assessment = people with dementia guided by a member of the research team
T0 = baseline before randomization, T1 = follow-up after 8 weeks, T2 = follow-up after 16 weeks