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Table 1 Outcome-parameter and instruments

From: Rationale, design and conduct of a randomised controlled trial evaluating a primary care-based complex intervention to improve the quality of life of heart failure patients: HICMan (Heidelberg Integrated Case Management)

Outcome-parameter

Instrument

Primary outcome

 

Quality of life

SF-36, scale 1 (PF)

Secondary outcomes

 

Quality of life

other scales of SF-36

Disease-specific Quality of life

KCCQ

Depression

PHQ-9

Anxiety disorder

GAD-7

Patient assessment of care

Modified PACIC

Adherence

EHFScBS and SANA

Disease course

NT-proBNP

Other comorbidity

CIRS, small geriatric assessment

Health care utilisation

Case report form (CRF)

Medication

CRF

Sociodemographic variables

Questionnaire

HICMan documentation of CM

CRF, PHQ-9, GAD-7 and small geriatric assessment