Yan 2018.
| Study characteristics | ||
| Methods |
Study design: single‐centre, open‐label, parallel individual randomised controlled trial in China Duration: 52 weeks Setting: respiratory and nosocomial infection departments at a hospital |
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| Participants |
Population: 240 adults recruited from the Respiratory and Nosocomial Infection Departments at a hospital in Wuhan, China Baseline characteristics: % Male: 60 RM and 66 UC, Mean age: 65.4 RM and 64.6 UC, % White: not reported, % African: not reported, % LTOT: not reported, % Home oxygen: not reported, % Anxiety or depression: not reported, baseline medications: not reported, FEV₁ (% mean): RM 40.98 and UC 41.08, FVC (% mean): not reported, FEV₁/FVC (% mean): RM 54.08 and UC 53.47, Current smokers (n): RM 108 and UC 104, GOLD stage: RM: I (12), II (27), III (67), IV (14) and UC: I (10), II (25), III (70), IV (15), COPD exacerbations last 12 months: not reported, Hospitalisations in past 12 months: not reported Inclusion criteria: not reported Exclusion criteria: not reported |
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| Interventions | Measurements at baseline and at 1 year Treatment arms
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| Outcomes |
Primary outcomes: pulmonary function tests, quality of life (CAT) assessments, hospitalisations Secondary outcomes: not reported |
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| Notes |
Funding: China Medical Board Other identifier: not reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Study authors reported that participants were randomly assigned but provided no further information |
| Allocation concealment (selection bias) | Unclear risk | No further information provided |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible to blind participants and personnel due to nature of the intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No further information provided |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | All participants were included, but it is unclear whether any withdrew |
| Selective reporting (reporting bias) | High risk | No Prisma diagram provided, data in Tables 3 and 4 (continuous data) not clear. Unclear whether SDs or SEs were reported. Trial not registered at trials website; unable to contact study author as email provided was incorrect. Contacted one of the other study authors; awaiting response |
| Other bias | Low risk | None |
6MWD: 6‐minute walking distance; 6MWT: 6‐minute walk test; A&E: accident and emergency visits; AECOPD: acute exacerbations of chronic obstructive pulmonary disease; AEs: adverse events; AMI: acute myocardial infarction; β₂‐agonist: beta2‐agonist; BODE: body mass index, airflow obstruction, dyspnoea, and exercise capacity index; BP: blood pressure; BRC: Biomedical Research Centre; CAT: Chronic Obstructive Pulmonary Disease Assessment Test; CCQ: Clinical Chronic Obstructive Pulmonary Disease Questionnaire; CF: cystic fibrosis; CHF: congestive heart failure; CHROMED: Telemonitoring in Chronic Obstructive Pulmonary Disease in five countries; CHRONIC: an information Capture and Processing Environment for Chronic Patients in the Information Society project; CI: confidence interval; COPD: chronic obstructive pulmonary disease; COPD‐SES: Chronic Obstructive Pulmonary Disease Self‐Efficacy Scale; CRDQ: Chronic Respiratory Disease Questionnaire; CSQ‐8: Client Satisfaction Questionnaire‐8; CTN: care transition nurse; CVD: cardiovascular disease; ED: emergency department; EDGE: sElf‐management anD support proGrammE; EF: ejection fraction; EpxCOPD: Epharmix chronic obstructive pulmonary disease system; EQ‐5D: EuroQoL 5 Dimensions Questionnaire; EQ‐5D‐3L: EuroQoL 5 Dimensions 3‐Level Version Questionnaire; EU: European Union; EuroQoL‐5D: European Quality of Life 5 Dimension Questionnaire; FEV₁: forced expiratory volume in one second; FEV₁/FVC: forced expiratory volume in one second/forced vital capacity ratio; FILAS: locations and financial instruments for producers in Rome and Lazio; FVC: forced vital capacity; GesEPOC: Spanish National Guidelines for Chronic Obstructive Disease Care; GOLD: Global Initiative for Obstructive Lung Disease; GOLD I: Global Initiative for Obstructive Lung Disease stage 1; GOLD II: Global Initiative for Obstructive Lung Disease stage 2; GOLD III: Global Initiative for Obstructive Lung Disease stage 3; GOLD IV: Global Initiative for Obstructive Lung Disease stage 4; GP: general practitioner; GSM: Group Special Mobile; HADS: Hospital Anxiety and Depression Scale; HADS‐A: Hospital Anxiety and Depression Scale ‐ Anxiety; HADS‐D: Hospital Anxiety and Depression Scale ‐ Depression; HCP: healthcare provider; HF: heart failure; HR: hazard ratio; HRQOL: health‐related quality of life; IC: integrated care; ICS: inhaled corticosteroid; ICT: information and communication technologies; ICU: intensive care unit; ILD: interstitial lung disease; ILL: interstitial lung disease; IQR: interquartile range; ISRCTN: primary clinical trial registry recognised by World Health Organization and International Committee of Medical Journal Editors; IST: Information Sciences and Technology; IV: intravenous; LABA: long‐acting beta‐adrenergic agonist; LAMA: long‐acting muscarinic antagonist; LINQ: Lung Information Needs Questionnaire; LOS: length of stay; LTOT: long‐term oxygen therapy; MARS: Medication Adherence Report Scale; MLHFQ: Minnesota Living With Heart Failure Questionnaire; MM: Mini Mental Test; MMSE: Mini Mental State Examination; MRC: Medical Research Council; (n): number; NCT: ClinicalTrials.gov identifier; NHS: National Health Service; NIHR: National Institute for Health Research; NIV: non‐invasive ventilation; NL Agency: division of the Dutch Ministry of Economic Affairs; NSW: New South Wales; O₂: oxygen; PDE4: phosphodiesterase 4 inhibitors; PHQ‐9: Patient Health Questionnaire‐9; PITES‐ISA: Strategic Health Action research projects; PR: pulmonary rehabilitation; QOL: quality of life; RACS‐Plus: Respiratory Ambulatory Care Service‐Plus; RCP: routine clinical practice; RM: remote in‐home telemonitoring; RN: registered nurse; SAA: short‐acting adrenergic; SABA: short‐acting beta2‐agonist; SAE: serious adverse event; SBP: standard best practice care; SC: standard care; SCL‐10A: Standard Checklist 10‐Item Anxiety Measure; SCL‐20: Standard Checklist 20‐Item Questionnaire; SD: standard deviation; SDB: sleep‐disordered breathing; SECD6: Self‐Efficacy for Managing Chronic Disease 6‐Item Scale; SE: standard error; SF‐36: Short Form 36 questionnaire; SF36v2: Short Form 36 questionnaire Italian version; SGRQ: St George’s Respiratory Questionnaire; SGRQ‐C: chronic obstructive pulmonary disease‐specific version of St George’s Respiratory Questionnaire; STATA: Software for Statistics and Data Science; TH: telehealth; THC: telehealthcare; TM: telemonitoring; UC: usual care; UK: United Kingdom.