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Chronic obstructive pulmonary disease (COPD): The impact of a telemetric COPD monitoring service

Chronic obstructive pulmonary disease (COPD): The impact of a telemetric COPD monitoring service - a randomised controlled trial with nested qualitative study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN96634935
Enrollment
300
Registered
2009-01-30
Start date
2009-01-01
Completion date
Unknown
Last updated
2018-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease Respiratory Other chronic obstructive pulmonary disease

Interventions

This is a one year researcher-blinded randomised controlled trial. Intervention group Patients in the intervention group will be given a modified "tablet" touch screen computer with video capabilit

Sponsors

University of Edinburgh (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Both males and females, no age limits 2. Patients registered with Lothian general practices admitted with an exacerbation of COPD as the primary diagnosis to one of the three acute hospitals in Lothian in the previous year

Exclusion criteria

Exclusion criteria: 1. Patients with other significant lung disease 2. Unable to consent 3. Unable to use the technology (e.g., inability to use the technology or complete the questionnaires) 4. Other more significant medical/social reasons at the GPs discretion

Design outcomes

Primary

MeasureTime frame
The time until first hospital admission with a primary diagnosis of an exacerbation of COPD up to one year post-randomisation. An exacerbation is a sustained worsening of the patient's symptoms from his or her usual stable state that is beyond normal day-to-day variations, and is acute in onset. Commonly reported symptoms are worsening breathlessness, cough, increased sputum production and change in sputum colour. The change in these symptoms often necessitates a change in medication. An exacerbation is defined as being the 'primary diagnosis' if the presenting symptoms are consistent with, and the patient is treated for an acute exacerbation of COPD, and if no other disease was treated as a priority.

Secondary

MeasureTime frame
1. Exacerbations and admissions 1.1. The time until first hospital admission with a primary diagnosis of an exacerbation of COPD or all-cause deaths up to one year post-randomisation 1.2. The difference in mean number of bed-days for emergency admissions with a primary diagnosis of COPD during one calendar year 1.3. The number of hospital admissions with a primary diagnosis of COPD during one calendar year 1.4. The number and duration of admissions in which COPD is listed in the discharge letter as a factor in the admission (i.e., not necessarily the primary diagnosis) during one calendar year 1.5. The number of exacerbations (defined as a sustained worsening of the patient's symptoms necessitating a change in medication) during one calendar year 1.6. Proportion of deaths at one year. Cause of death will be taken from the primary and/or secondary care clinical records. 2. Quality of life 2.1. St George's Respiratory Questionnaire (SGRQ) at one year. The SGRQ is a validated and widely used instrument which measures health impairment (symptoms, activities and impacts) in patients with COPD on a scale: 100 (greatest impairment) to 0, is responsive to change, with a minimum important difference (MID) of 4. 2.2. Proportion of patients with an improvement of 4 or more units in the SGRQ at one year. 3. Anxiety and depression 3.1. Hospital Anxiety and Depression Scale (HADS) at one year. The HADS is a validated questionnaire with independent scales for anxiety and for depression (scores >=11 indicate significant anxiety [or depression]; scores <=7 are normal) 4. Patient knowledge and self-efficacy 4.1. Self-Efficacy for Managing Chronic Disease 6-item scale (SECD6) at one year. The SECD6 assesses confidence in ability to self-manage symptoms and impact on life on a scale of 1 (low self-efficacy) to 10 (high). It has been used in a range of long-term conditions. 4.2. Lung Information Needs Questionnaire (LINQ) at one year. The LINQ measures the informatio

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 22, 2026