Optimising the feasibility and acceptability of a multi-component, digital health intervention to improve outcomes for people with chronic obstructive pulmonary disease

Not Applicable

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); Respiratory

• Registration Number: ISRCTN82570166
• Lead Sponsor: Clinical Trials and Research Governance – University of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-05
• Last Update Posted: 28 November 2023
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

1. Be willing and able to give informed consent
2. Be aged 40 years or older
3. Have a clinical diagnosis of chronic obstructive pulmonary disease recorded in their medical history
4. Be a current or ex-smoker
5. Be an acute hospital attendance/admission for an exacerbation of chronic obstructive pulmonary disease or pulmonary infection
6. Be able to complete questionnaires (electronic or paper) and use the tablet computer
7. Confirm their post-discharge destination is not a medical facility or prison
8. Lives in Oxfordshire or surrounding counties
9. Be able to adequately understand verbal and written English

Exclusion Criteria

1. Another significant lung disease e.g. lung cancer
2. Chronic heart failure defined by the New York Heart Association classification system as severe (Grade IV)
3. Have a life expectancy of less than six months or be on a palliative pathway

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Proportion of participants in whom data can be obtained and matched from the in-hospital system and the EDGE2 platform – extract and link in-hospital data with other study data for each patient, success pre-defined as 80-90% – initiation of linkage will take place upon provision of consent with in-hospital data retrieved from point of index attendance/admission to discharge.<br>2. Proportion where there is sufficient data to provide clinically relevant data for use across the care pathway – obtain and link in-hospital data with other study data for each patient, success pre-defined as 80-90% – initiation of linkage will take place upon provision of consent with in-hospital data retrieved from point of index attendance/admission to discharge.

Secondary Outcome Measures

Name	Time	Method
1. Quality of life - using St George’s Respiratory Questionnaire for COPD (SGRQ-C) - at baseline and 6 months after hospital discharge<br>2. Generic health status - using the EuroQol-5 Dimension (EQ-5D-5L) scale - at baseline and 6 months after hospital discharge<br>3. Number of hospital admissions - at baseline and 6 months after hospital discharge<br>4. Number of ICU admissions - at baseline and 6 months after hospital discharge<br>5. Number of contacts with health professionals - at baseline and 6 months after hospital discharge<br>6. Use of medications - at baseline and 6 months after hospital discharge<br>7. Physical function – using the sit-to-stand test - at baseline, 4 weeks, 12 weeks and 24 weeks after hospital discharge <br>8. Death - using NHS Digital’s Data Access Request Service<br>9. Attendance and admissions to hospital – using NHS Digital’s Data Access Request Service