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COPD in Primary Care Study

A singlecentre, exploratory, cluster randomised controlled trial of a complex psychosocial intervention for the management of COPD

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN49632858
Enrollment
900
Registered
2012-12-19
Start date
2012-11-05
Completion date
Unknown
Last updated
2016-10-17

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

Conditions

Depression Mental and Behavioural Disorders Depressive episode, unspecified

Interventions

We plan to undertake an exploratory cluster randomised controlled trial in primary care to evaluate a psychosocial intervention for patients with COPD. The intervention is at the level of the practice

Sponsors

Manchester Mental Health & Social Care Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. All patients must have chronic obstructive pulmonary disease 2. All patients must be 18 years or over and be able to read and write 3. We will use MMHSCT Linkworkers where appropriate so that patients, who do not have a good command of English, can still participate in the project 4. The COPD liaison workers will be able to access Link workers for any patients identified in the GP practice to be eligible for their service 5. Male or female participants

Exclusion criteria

Exclusion criteria: 1. People below the age of 18 years 2. People with learning disabilities, dementia or brain damage 3. Patients who lack capacity to consent in research 4. People who are deemed to be too physically unwell by their GP to participate in the research 5. People who are considered at risk of suicide such that referral to mental health crisis services are warranted or admission to an inpatient psychiatric bed.

Design outcomes

Primary

MeasureTime frame
Use of unscheduled care

Secondary

MeasureTime frame
1. Use of scheduled care 2. Health status (EQ5D; The EuroQoL Group 1990) 3. Severity of COPD (Eisner et al. 2005) 4. Quality of life (Chronic Respiratory Questionnaire; Williams et al. 2001) 5. Hospital Anxiety and Depression Scale (Zigmond and Snaith 1983) 6. Qualitative study to explore the acceptability of the training and support offered to practices (primary care staff) and patients' experiences of the psychosocial intervention and care from their practice. Primary and secondary outcomes measured at baseline and 12 months

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026