Skip to main content

Table 2 Outcome instruments

From: 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

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

  1. aCare levels based on the assessment of the experts of the medical service of the health insurance funds
  2. bOnly subgroup of eight nursing homes of the Lübeck Study Centre
  3. 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
  4. dSelf-assessment = people with dementia guided by a member of the research team
  5. T0 = baseline before randomization, T1 = follow-up after 8 weeks, T2 = follow-up after 16 weeks