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

Bablok, Isabella; Binder, Harald; Stelzer, Dominikus; Kaier, Klaus; Graf, Erika; Wangler, Julian; Jansky, Michael; Löhr, Michael; Schulz, Michael; Kockläuner, Marie; Geschke, Katharina; Wuttke-Linnemann, Alexandra; Fellgiebel, Andreas; Farin, Erik

doi:10.1186/s12877-021-02114-z

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
Construct	Respondents	t0	t1	t2	Group comparison
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
Stability of care situation (patients and caregivers)	Case managers IG			DSV	IG vs. CG1
Days spent in hospital (patients)	Patients and caregivers IG	Original item	Original item		IG vs. CG2
Days spent in hospital (patients)	Routine data CG2	Aggregated data from health insurance companies	Aggregated data from health insurance companies		IG vs. CG2
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
Utilization of outpatient support services (caregivers)	Case managers IG + CG1	Original item	Original item		IG vs. CG1
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

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 (t0_GP, t1_GP, t2_GP)

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ISSN: 1471-2318

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