Efficacy of team-based collaborative care for distressed patients in secondary prevention of chronic coronary heart disease (TEACH): study protocol of a multicenter randomized controlled trial

Table 2 Visit schedule and assessments

Periods	Name	Screen 1 (in-hospital)	Screen 2 (telephone)	Randomization	Treatment		Follow-up
Visits	Name	Screen 1 (in-hospital)	Screen 2 (telephone)	Baseline Assessment (Visit)	6 months (telephone)	EOT (visit)	FU 18 (visit)	FU 24^a (telephone)	FU 30^a (telephone)
Visits	Time	Day-120–day-90	Day-14	Day 0	Month 6	Month 12	Month 18	Month 24	Month 30
informed screening consent		X
Screen 1: Inclusion and exclusion criteria		X
Screen 2: Inclusion and exclusion criteria			X
Informed study consent				X
Demographics				X		X	X
Medical History^b				X	X	X	X
Physical examination^c				X		X	X
Laboratory tests^d				X		X	X
Psychometric battery 1^e				X	X	X	X	X	X
Psychometric battery 2^f				X		X	X
Medication				X	X	X	X	X	X
Actimetry				X		X	X
Adverse Events/Vital Status				X	X	X	X	X	X

EOT end of study treatment, FU follow-up
^aFU 18 will be administered in all participants to measure treatment durability. FU 24 and FU 30 will only be administered before the end of study, i.e. only in participants included during the first 12 or 6 months, of recruitment, respectively
^bFull medical history and demographics will be obtained at baseline only. Only relevant changes from baseline will be documented during later assessments
^cPhysical examination will typically be limited to heart rate, blood pressure, body height (baseline only) and weight. Other physical examinations will only be performed based on clinical need
^dLaboratory tests comprise LDL cholesterol, HbA1c, creatinine, and cotinine
^eQuestionnaires included: HeartQoL (primary outcome), HADS, PSS-4
^fQuestionnaires included: see Table 4

ISSN: 1471-2261