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Table 1 Study Measures and Testing Occasions

From: A timed activity protocol to address sleep-wake disorders in home dwelling persons living with dementia: the healthy patterns clinical trial

Domain (purpose)

Measure

Description

Respondent

Testing Occasion

PLWD cognitive status (descriptive, possible covariate)

Clinical Dementia Rating (CDR) [27]

Cognitive status

PLWD

Nurse visit

PLWD physical function (descriptive, possible covariate)

Barthel Index [31]

CG proxy report of PLWD dependence level

Caregiver

T1

PLWD Quality of life as rated by CG (primary outcome)

QOL-AD [32]

12 domains

Caregiver

T1, T2

Sleep Wake disorder

Actigraph [33]

WASO, TST, day/night sleep ratio, number of night awakenings

PLWD

T1, T2

Subjective sleep PLWD

PROMIS Sleep Related Impairment [34]

Symptoms of sleep impairment in PLWD

Caregiver

T1, T2

Subjective sleep of caregiver

Pittsburgh Sleep Quality Index (PSQI) [35]

Sleep quality rating

Caregiver

T1, T2

HPA Axis activity (possible mechanism)

Salivary cortisol [36] Salivary melatonin [36]

Diurnal stress across the day

PLWD

T1, T2

Demographics (descriptive, possible covariate)

Caregiver and PLWD Information (US Census + other sources)

Basic background characteristics

Caregiver

T1

Medications (descriptive, possible covariate)

PLWD medications

Brown bag review of prescription and non-prescription meds

Brown bag review

Nurse visit

PLWD physical health (descriptive, possible covariate)

Charlson Comorbidity Index [37]

CG Proxy report of health

Caregiver

T1

Neuropsychiatric Behaviors (secondary outcome)

Neuropsychiatric Inventory (NPI) [38]

For each NPI behavior, CG rates upset (0 = no upset to 4 = very upset); Vigilance items ask CG to estimate time spent in care (alpha = .89)

Caregiver

T1, T2

Caregiver strain (secondary outcome)

Zarit Burden Interview (12) [39]

Caregiver burden

Caregiver

T1, T2

CG Depressive symptoms (potential moderator)

CES-D short form [40]

10-items; sensitive to change; Cut off for depression ≥8

Caregiver

T1, T2

Evaluation of study/ Quality control (descriptive, quality control)

Program Evaluation (Adapted from investigator’s previous studies)

Caregiver satisfaction with and utility of intervention; quality assurance

Caregiver

Telephone survey following T3

  1. Note: PlwD person living with dementia, T1 baseline, T2 1-month follow-up, T3 2-month follow-up. We estimate interviews with to average 1 h