Walker 2017.
| Methods |
Study design: multi‐centre, open‐label, parallel individual randomised controlled trial in Estonia, Slovenia, Spain, Sweden, United Kingdom Duration: 39 weeks Setting: hospital, clinic, community health service |
| Participants |
Population: 312 adults recruited from 6 sites (hospital, clinic, community health service) in 5 countries (Estonia, Slovenia, Spain, Sweden, UK) Baseline characteristics: % Male: 66 IC and 65 UC, Mean age: 71 IC and 71 UC, % White: not reported, % African: not reported, % LTOT: not reported, % Home oxygen: not reported, % Anxiety and depression: Mean depression PHQ9 score was 6.27 (IC) and Mean depression PHQ9 score was 5.97 (UC), Baseline meds: not reported, FEV₁: IC 49.4 and UC 50.4, FVC: IC 73.8 and UC 75.8, FEV₁/FVC: IC: 0.53 and UC: 0.53, Current smokers (n): not reported, GOLD stage: IC: I (3%), II (47%), III (36%), IV (15%) and UC: I (2%), II (48%), III (39%), IV (11%), COPD exacerbations last 12 months: 1 exacerbation: IC 63 (41%) and UC 59 (37%); more than 1 exacerbation: IC 91 (59%) and UC 99 (63%), Hospitalisation in past 12 months: IC 64 (42%) and UC 65 (41%) Inclusion criteria: GOLD grade II or higher, exacerbations or hospitalisation or both in the last year, comorbidities such as CHF, SDB, smoking pack‐years > 10 years, able to provide written consent, able to use TM equipment at home, reliable mobile phone coverage at home, > 60 years of age Exclusion criteria: any condition likely to put patient at risk, significant visual or mental condition, planned long‐time absence from home |
| Interventions | Measurements taken at baseline and at end of study Treatment arms
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| Outcomes |
Primary outcomes: time to first hospitalisation, quality of life (change in EQ‐5D utility index score) Secondary outcomes: moderate exacerbation rate, hospitalisation, CAT, PHQ‐9, MLHFQ questionnaires, cost‐utility analysis |
| Notes |
Funding: European Commission grant Other identifier: NCT01960907 |
AECOPD: acute exacerbations of chronic obstructive pulmonary disease; CAT: Chronic Obstructive Pulmonary Disease Assessment Test; CE: Conformity European (marked Philips Motiva System); CES‐D: Centre for Epidemiologic Studies Depression Scale; CHF: congestive heart failure; CLAHRC: Collaborations for Leadership in Applied Health Research and Care; COPD: chronic obstructive pulmonary disease; CRQ: Chronic Respiratory Disease Questionnaire; CWD: chest wall disease; DM: diabetes mellitus; DSL: digital subscriber line; ED: emergency department; EQ‐5D: EuroQoL 5 Dimensions Questionnaire; EQ‐5D‐5L: EuroQoL 5 Dimensions 5‐Level Version Questionnaire; EuroQoL‐5D: European Quality of Life 5 Dimension Questionnaire; EXACT: Exacerbations of Chronic Pulmonary Disease Tool; FEV₁: forced expiratory volume in one second; FEV₁/FVC: forced expiratory volume in one second/forced vital capacity ratio; FVC: forced vital capacity; 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; HADS: Hospital Anxiety and Depression Scale; heiQ: Health Education Impact Questionnaire; HF: heart failure; HRQOL: health‐related quality of life; IC: integrated care; ICD10: International Statistical Classification of Diseases and Related Health Problems, Tenth Edition; ICER: incremental cost‐effectiveness ratio; ICU: intensive care unit; IMC: equivalent to body mass index; ISDN: Integrated Services Digital Network; LABA + ICS: long‐acting beta‐adrenergic agonist + inhaled corticosteroid; LAMA: long‐acting muscarinic antagonist; LTOT: long‐term oxygen therapy; MIC/VC: maximal insufflation capacity/vital capacity ratio; MLHFQ: Minnesota Living With Heart Failure Questionnaire; mMRC: Modified Medical Research Council; MRC: Medical Research Council; (n): number; NIHR: National Institute for Health Research; NMD: neuromuscular disease; nt: number of packages of cigarettes smoked daily, number of years of smoking; OHS: obesity hypoventilation syndrome; OSA: obstructive sleep apnoea; PaCO₂: partial pressure of carbon dioxide; PC: primary care; PCF: peak cough flow; PDA: personal digital assistant; pH: power of hydrogen (acidity or basicity of aqueous solution); PHQ‐9: Patient Health Questionnaire‐9; QOL: quality of life; QOL SF‐36: Health‐Related Quality of Life as Measured by Short Form 36 Version 2 Questionnaire; RM: remote in‐home telemonitoring; SATISFAD 10: instrument that evaluates satisfaction with home care services, self‐administered; SDB: sleep‐disordered breathing; SF‐12: Short Form 12 Questionnaire; SF‐36: Short Form 36 Questionnaire; SGRQ: St George’s Respiratory Questionnaire; SPMSQ: Short Portable Mental Status Questionnaire; STAI: State‐Trait Anxiety Inventory; STAI‐6: State Trait Anxiety Inventory ‐ 6 anxiety scores; TLC: total lung capacity; TM: telemonitoring; TV: television; UC: usual care; UK: United Kingdom; w/o: without.