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A Randomised Controlled Trial of Self-Management Support for Primary Care Patients with Chronic Obstructive Pulmonary Disease (COPD) and other Chronic Health Conditions

Activating Primary Care COPD Patients with Multimorbidity (APCOM) Trial - A Cluster Randomised Controlled Trial of the Effect of Self-Management Support on Quality of Life

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000568718
Acronym
APCOM Trial
Enrollment
238
Registered
2022-04-13
Start date
2022-11-24
Completion date
2024-04-10
Last updated
2024-09-02

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

Conditions

None listed

Brief summary

Chronic Obstructive Pulmonary Disease (COPD) is a common chronic condition that can progress to disability and death. COPD frequently occurs in the context of other long-term conditions (multimorbidity). There is a lack of effective self-management programs for COPD in primary care. This cluster randomised controlled trial will test a self-management support intervention, based on the Health Belief Model (HBM), delivered primarily by Practice Nurses (PN) that is tailored to patient needs and recognises the context of multimorbidity. In a pilot study, this innovative intervention was associated with improvements in patient activation, COPD-related quality of life and COPD knowledge. The APCOM trial will rigorously test, using a cluster randomised controlled design, whether this intervention is effective in improving quality of life, decreasing COPD exacerbations and increasing patient knowledge of COPD and can be effectively implemented in primary care.

Interventions

Patients from general practices in the intervention arm will receive a tailored, multi-component self-management program delivered by practice nurses (PNs). The program will assist the PNs to systematically address patients’ beliefs, perceived benefits of action and barriers to action, self-efficacy (engagement or lack of engagement) and use stimuli (cues to action) to trigger COPD self-management behaviours such as accurate inhaler device technique, regular physical activity, good nutrition, et

Patients from general practices in the intervention arm will receive a tailored, multi-component self-management program delivered by practice nurses (PNs). The program will assist the PNs to systematically address patients’ beliefs, perceived benefits of action and barriers to action, self-efficacy (engagement or lack of engagement) and use stimuli (cues to action) to trigger COPD self-management behaviours such as accurate inhaler device technique, regular physical activity, good nutrition, etc. The program will be tailored based on patients’ individual demographics, priorities and motivation to ensure that the level of support provided is appropriate to the needs of the participants and engagement in change will be supported using motivational interviewing (MI). The PNs in the intervention group will deliver the program through an initial assessment session followed by up to four health coaching sessions spaced two weeks apart. Each session will be of 30-45 minute duration; the sessions will held face-to-face at the practice or via a virtual meeting platform, as suited to the patient and the PN. The focus of the assessment session is for the PN to gauge the patient's overall health status, individual health priorities and goals, complete the COPD Action Plan by Lung Foundation Australia and assess accuracy of inhaler device technique. The actual number of health coaching sessions required for a patient will be determined by the PNs on a case-by-case basis depending on the initial assessment and individual factors such as socioeconomic status, prior knowledge of COPD, co-existing comorbidities, motivation and readiness to change. A website collating educational resources, including information on COPD by Lung Foundation Australia, inhaler device technique videos by the National Asthma Council Australia, relevant information on vaccination and smoking cessation & abstinence by the Australian Government Department of Health, will be collated on a website that will be accessible patients and providers in the intervention group. Resources created specifically for the program, such as the assessment and planning template to facilitate the health coaching sessions, patient reflection logs for goal setting during each session and completion between sessions, and motivational fridge magnets for patients, will be provided to the PNs to in the intervention group prior to the initial assessment session. Following the last session, PNs will make a monthly follow-up phone call to the patients for three months. The purpose of the monthly follow-up calls are an opportunity for the PNs to motivate patients to continue working towards health goals and keeping up health behaviours following the last health coaching session, as well as to check on their overall health and wellbeing. A template for recording patients' attendance to the health coaching sessions as well as the three monthly follow-up phone calls will also be provided to PNs in the intervention group.

Sponsors

Professor Nicholas Zwar, Bond University
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Eligible general practices will have computer-based patient records and employ at least one PN (a registered practice nurse). Patients will be eligible if they are: i) 40 years or older; ii) have a spirometry-confirmed diagnosis of COPD; iii) have visited their general practice in the last 12 months; and iv) have at least one existing co-morbidity.

Exclusion criteria

Potential participants will be excluded if they: i) have significant cognitive impairment; or ii) are unable to understand English language sufficiently to complete study questionnaires and follow the intervention.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026