Mohan 1999.

Methods	DETAILS OF STUDY AIM OF INTERVENTION: to enhance compliance with the use of the home apnea monitor for infants discharged on an apnea monitor. AIM OF STUDY: this study was designed to test whether weekly telephone contact with a health professional would improve the use of the home apnea monitor. STUDY DESIGN: RCT. METHODS OF RECRUITMENT OF PARTICIPANTS: all infants discharged on apnea monitor during a 1.5 year period, were eligible for this study. INCLUSION CRITERIA FOR PARTICIPATION IN STUDY: preterm infants with abnormal pneumocardiogram, patients with bronchopulmonary disease requiring oxygen support/ siblings of a sudden infant death syndrome victim, others infants with various pulmonary, cardiac or neurologic problems. EXCLUSION CRITERIA FOR PARTICIPATION IN STUDY: not specified. INFORMED CONSENT OBTAINED? yes. ETHICAL APPROVAL? yes. FUNDING: unclear. ASSESSMENT OF STUDY QUALITY ALLOCATION CONCEALMENT: unclear. EPOC‐ QUALITY CRITERIA 2002: C. high risk of bias. METHOD OF GENERATING RANDOMISATION SCHEDULE: stratified balanced block technique. METHOD OF CONCEALMENT OF ALLOCATION: unclear. BLINDING: ·PARTICIPANTS: no. ·PROVIDER/S: no. ·OUTCOME ASSESSOR/S: yes. INTENTION TO TREAT ANALYSIS: not stated. BASELINE COMPARABILITY OF INTERVENTION AND CONTROL GROUPS: yes. STATISTICAL METHODS AND THEIR APPROPRIATENESS: t‐test/Mann‐Whitney U‐test/chi‐square. CONSUMER INVOLVEMENT: not stated.
Participants	DESCRIPTION: pediatric patients. GEOGRAPHIC LOCATION: USA. SETTING: discharged home from an acute care setting. NUMBER OF PARTICIPANTS: ELIGIBLE: 69. RANDOMISED TO INTERVENTION: 30. RANDOMISED TO CONTROL: 32. INCLUDED IN ANALYSIS INTERVENTION GROUP: 30. INCLUDED IN ANALYSIS CONTROL GROUP: 32. AGE: RANGE OR MEAN (SD): 0.5 in infants/ 25 years in mothers. GENDER (% MALE): not stated. ETHNICITY: not stated. PRINCIPAL HEALTH PROBLEM OR DIAGNOSIS: preterm infants with abnormal pneumocardiogram, patients with bronchopulmonary disease requiring oxygen support/ siblings of a sudden infant death syndrome victim, others infants with various pulmonary, cardiac or neurologic problems. OTHER HEALTH PROBLEM/S: unclear. TREATMENT RECEIVED/RECEIVING: OTHER SOCIAL/DEMOGRAPHIC DETAILS: 50% of mothers married.
Interventions	DETAILS OF INTERVENTION: above the care comparable to the control group, patients in the experimental group received an additional phone call consisting of a structured interview every week for a total of 8 weeks. The questionnaire addressed the use of monitors and the well‐being of the baby, including any need for an office visit or hospitalisation. DETAILS OF CONTROL: care for all groups: access to a physician in the neonatal intensive care unit at all times, initial instruction as well as support 24 hours per day from the monitor vending company, follow‐up visits with a neonatologist or pediatrician within 2 weeks of discharge and about every month for the next 3 months and most infants had 1‐3 visits by a home nurse in the first 2 weeks following discharge. CO‐INTERVENTION? yes. DETAILS OF CO‐INTERVENTIONS: see control intervention. DELIVERY OF INTERVENTION: Frequency: 8. First time at day 7 after discharge. Period: 8 weeks. PROVIDERS: unclear, probably physician. INTERVENTION QUALITY: unclear. FIDELITY/INTEGRITY: unclear.
Outcomes	NUMBER OF OUTCOMES: 2 OUTCOME / TOOL / TOOL VALIDATED / METHOD OF ASSESSMENT / TIME OF ASSESSMENT A.Psycho‐social health of patients (uncertainty, anxiety, informational needs, mood, coping, quality of life, social activity, ..): Satisfaction / self‐developed / partly, adopted from Gerard and Peterson's cardiac patient learning needs inventory / unclear / unclear, but in first month after discharge. B.Physical health of patients (eg. functional status, self‐care, self‐efficacy, independence, ..): C.Other consumer oriented outcomes (eg. treatment adherence, knowledge, adverse events, ..): Knowledge / self‐developed: heart disease management questionnaire / partly; Kuder‐Richardson coefficient 0.36 / unclear / unclear, but in first month after discharge. D. Health service delivery oriented outcomes (eg. hospital readmission, health services utilization, ..):
Notes	·CHANGES IN TRIAL PROTOCOL ·CONTACT WITH AUTHOR ·POWER CALCULATION? yes. ·RECORD IF THE STUDY WAS TRANSLATED FROM A LANGUAGE OTHER THAN ENGLISH. ·RECORD IF THE STUDY WAS A DUPLICATE PUBLICATION.
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear