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Table 2 Secondary endpoints relating to patients and caregivers

From: Primary dementia care based on the individual needs of the patient: study protocol of the cluster randomized controlled trial, DemStepCare

Construct Respondents Instrument at a given time Group comparison
t0 t1 t2
Quality of life (caregivers) Caregivers
IG + CG1
World Health Organization Quality of Life Short Form (WHOQOL-Bref) [67] WHOQOL-Bref   IG vs. CG1
Comorbidities (caregivers) Caregivers
IG + CG1
Comorbidity Score (KoMo-Score) [71] KoMo-Score   IG vs. CG1
Stress (caregivers) Caregivers
IG + CG1
Perceived Stress Scale (PSS-10) [69, 68] PSS-10   IG vs. CG1
Case managers
IG + CG1
10 point scale 10 point scale   
Case managers
IG
   10 point scale  
Resilience (caregivers) Caregivers
IG + CG1
Brief Resilience Scale (BRS) [70] BRS   IG vs. CG1
Stability of care situation (patients and caregivers) Case managers
IG + CG1
Dementia specific screening tool (in German: Demenzspezifisches Screening zur Versorgungssituation, DSV [47]) DSV   IG vs. CG1
Case managers
IG
   DSV
Days spent in hospital (patients) Patients and caregivers
IG
Original item Original item   IG vs. CG2
Routine data
CG2
Aggregated data from health insurance companies Aggregated data from health insurance companies  
Hospital admissions (patients) Patients and caregivers
IG + CG1
Original item Original item   IG vs. CG1
IG vs. CG2
Routine data
IG + CG1
Individual data from health insurance companies Individual data from health insurance companies Individual data from health insurance companies
Routine data
CG2
Aggregated data from health insurance companies Aggregated data from health insurance companies  
Utilization of outpatient support services (caregivers) Caregivers
IG + CG1
Original item Original item   IG vs. CG1
Case managers
IG + CG1
Original item Original item  
Quality and safety of medication (patients) Pharmacy
IG + CG1
Medication review (using the Medication Appropriateness Index (MAI) [63, 62], START criteria [64], PRISCUS-list [65], FORTA-list [66], STOPP-criteria [64], deprescribing strategies, PCNE version 9.0) Medication review Medication review IG vs. CG1
  1. IG intervention group, CG control group, t0 = study inclusion, t1 = minimum duration of the intervention / nine months after t0, t2 = end of intervention / max. 27 months after t0. The secondary endpoints which refer to the GPs are not shown in this table because there are different measurement times (t0GP, t1GP, t2GP)
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