Schmid 2016.

Methods	Study design: parallel RCT; 56 assessed for eligibility, 46 randomised Study duration: 12 months Study follow‐up: 12 months
Participants	Country: Germany Setting: community Adult kidney transplant recipients Number: intervention group (23); control group (23) Median, range (years): intervention group (46, 18 to 59); control group (51, 19 to 66) Sex (M): intervention group (61%); control group (48%) Exclusion criteria: not reported
Interventions	Intervention type classification: behavioural counselling eHealth intervention used: Telehealth Intervention group Standard care + telemedically supported care Chronic case management for 1st year post transplant, case management process applicable for acute care situations and a telemedically equipped team Prior to discharge nurse‐trained participants in operation of interactive terminal which enabled remote telemonitoring and prompt real‐time video consultations. Participants answered standardised multiple‐choice questionnaires via the terminal daily Data transferred through safe web‐based connection Supplementary briefings were provided by calls, voice mailbox, SMS and emails to the nurses mobile telephone ensuring prompt responses Nurse had 24‐hour access to all significant medical data. After discharge nurse provided planning, linking and monitoring for achievement of jointly agreed goals, underpinned by self‐management and self‐care related actions Participants had continuous access to expert to discuss specific challenges and to set daily priorities. Nurse regularly assessed details via telemonitoring, VC and mobile phone. If acute issues emerged nurse contacted nephrologist for intervention Nurse regularly assessed details via telemonitoring, VC and mobile phone. If acute issues emerged nurse contacted nephrologist for intervention Control group Standard care Received a booklet for recording drug regimen, vital signs and fluid balance Educational booklet Transplant nurse provided counselling which included standardised self‐management information about disease prevention, immunosuppression adherence and self‐monitoring Regular check‐ups with nephrologist combined with best clinical practice check‐up program. Physicians determined time intervals between check‐ups according to risk stratification and further consultations when needed
Outcomes	Data reported at baseline, 3, 6 and 12 months. Used intention‐to‐treat analysis Medical outcomes ‐ unplanned hospital admissions, length of unplanned admissions, acute rejection rate, length of time before rejection therapy initiated, ambulatory care visit rate Medication adherence ‐ composite adherence score and CAS % grade (Basel Assessment Adherence to Immunosuppression scale (BAASIS), collateral reports from physicians and nurses, hit target tac level) Quality of life (fragebogen alltagskeben ALL, ESRD‐SCL, BSI‐18) Cost analysis (unplanned inpatient costs, work time %)
Notes	Funding source: The project received funding by the European Union within the framework of the INTERREG IV Oberrhein (grant reference number “A12—Promethee")
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer generated randomisation schedule provided by the Institute of Medical Biometry and Medical Informatics
Allocation concealment (selection bias)	Unclear risk	Quote: "concealed allocation" but no further information
Blinding of participants and personnel (performance bias) Blinding of participants	High risk	Could not have been blinded
Blinding of participants and personnel (performance bias) Blinding of personnel	High risk	Nurses delivering intervention could not have been blinded
Blinding of outcome assessment (detection bias) Objective outcome	Low risk	Hospital admissions, LOS, adherence
Blinding of outcome assessment (detection bias) Subjective outcomes	Unclear risk	Psychosocial measures were validated and assessed by psychologist ‐ no mention of whether psychologist blinded to allocation
Incomplete outcome data (attrition bias) All outcomes	Low risk	Used intention‐to‐treat analyses, low loss to follow‐up
Selective reporting (reporting bias)	Unclear risk	Insufficient information to permit judgement
Other bias	Unclear risk	Small sample size