A mHealth intervention to reduce perceived stress in patients with ischemic heart disease: study protocol of the randomized, controlled confirmatory intervention “mStress-IHD” trial

Table 1 Overview of the assessment schedule of the mStress-IHD trial

	Planned assessment time points
Measures	Baseline (T0–month 0)	During treatment (weekly assessment)	End of treatment (T1–month 3)	Follow-up 1–4 (T2–T5–months 4, 6, 9, 15)	Dropout
Primary outcome
Combined stress measure^a	x		x	x	x
Secondary outcomes
Health-related quality of life
SF-36	x		x	x
EQ-5D-5L	x		x	x
Angina-related physical function and quality of life
SAQ	x		x	x
Functional capacity
6-min walk test	x		x	x
Blood pressure and heart rate
Three consecutive measurements at rest	x		x	x
Self-efficacy
GSES	x		x	x
Depression and anxiety symptoms
BDI-II	x		x	x
STAI	x		x	x
PHQ-4	x	x	x	x
Anger
PROMIS-Anger	x		x	x
Distress
GHQ-12	x		x	x
DT	x	x	x	x
Perceived stress
PSS	x		x	x
Client satisfaction, usability, predictors of usage, and internet-related variables
CSQ-I			x		x
SUS			x		x
UTAUT	x
ETHSA			x		x
Internet-related variables	x
Time to drop out and usage behavior
Usage behavior via backend		x
Demographic and medical characteristics	x
Utilization of healthcare services	x		x	X^b

BDI-ll Beck Depression Inventory, STAI State-Trait Anxiety Inventory, PROMIS-Anger, Patient-Reported Outcomes Measurement Information System-Anger scale, GHQ General Health Questionnaire-12 item version; PSS Perceived Stress Scale, SF-36 Short-Form-36 health questionnaire, EQ-5D-5L European Quality of Life 5 Dimensions 5 Level Version, SAQ Seattle Angina Questionnaire, GSES General Self-Efficacy, DT Distress Thermometer, PHQ-4 Patient Health Questionnaire-4, CSQ-I Client Satisfaction Questionnaire adapted to Internet-based interventions, SUS System Usability Scale, UTAUT Unified theory of acceptance and use of technology model, ETHSA Evaluation Tool for Healthcare Smartphone Applications, QALY cost per additional quality-adjusted life year
^aThe combined stress measure includes Beck Depression Inventory II (BDI-II), State-Trait Anxiety Inventory (STAI), Patient-Reported Outcomes Measurement Information System (PROMIS)–Anger, General Health Questionnaire (GHQ), and Perceived Stress Scale (PSS)
^bUtilization of health care services will be documented after 6, 9, and 15 months

ISSN: 1745-6215