Table 1.

Trial registration data

Data category	Information
Primary registry and trial identifying number	ClinicalTrials.gov (NCT03496948)
Date of registration in primary registry	23 March 2018
Source(s) of monetary or material support	Innovation Fund, Federal Joint Committee (G-BA)
Trial sponsor	KKH Kaufmännische Krankenkasse
Contact for public queries	FB (frank.bienert@kkh.de), KKH Kaufmännische Krankenkasse
Contact for scientific queries	FR (f.rezvani@uke.de), University Medical Center Hamburg-Eppendorf
Public title	TeGeCoach—a home-based exercise programme using telephone health coaching with telemonitoring for patients with peripheral artery disease
Scientific title	Telephone health coaching with exercise monitoring using wearable activity trackers (TeGeCoach) for improving walking impairment in peripheral artery disease: study protocol for a randomised controlled trial
Countries of recruitment	Germany
Health condition(s) or problem(s) studied	Peripheral artery disease (PAD)
Intervention(s)	Active comparator: telemonitored intermittent walking exercise with medical supervision by a physician and telephone health coaching (TeGeCoach)
	Active comparator: care-as-usual (CAU)
Key inclusion and exclusion criteria	Ages eligible for study: ≥35 years and ≤80 years Sexes eligible for study: both Accepts healthy volunteers: no
	Inclusion criteria: ≥35 years and ≤80 years, insured at one of the participating statutory health insurance funds, access to a telephone, primary or secondary diagnosis of PAD at Fontaine stage IIa/b within the last 36 months, no primary or secondary diagnosis of PAD at Fontaine stage I within the last 12 months, no diagnosis of Fontaine stage III/IV within the last 36 months
	Exclusion criteria: immobility that goes beyond claudication, inability to carry out intervention (chronic) physical conditions that interfere with the intervention, cognitive disorders, severe and persistent mental disorders, suicidality, life-threatening illnesses, active or recent participation in any other PAD intervention trial, ongoing hospitalisation, alcoholism and/or other drug dependency, heart failure graded NYHA classes III and IV
Study type	Interventional
	Allocation: randomised Intervention model: parallel assignment masking: analysis blinding
	Primary purpose: prevention
Date of first enrolment	April 2018
Target sample size	1760
Recruitment status	Completed
Primary outcome(s)	PROM: walking impairment Time points: baseline, 12 and 24 months
Key secondary outcomes	PROMs: generic health-related quality of life, PAD-specific quality of life, depression, generalised anxiety disorder, alcohol use, nicotine dependence, health literacy, patient activation Claims data: total healthcare costs, healthcare resource use, (severe) adverse events Time points: baseline, 12 and 24 months

NYHA, New York Heart Association; PROM, patient-reported outcome measures.