None listed
Conditions
Brief summary
Chronic Obstructive Pulmonary Disease (COPD) is a common, long-term health condition that usually co-exists with other long-term conditions (comorbidities), which can lead to low health-related quality of life and death. Poor inhaler device technique and medication adherence further impact management of COPD, and can be improved by tailored, self-management support. This pragmatic randomized controlled clinical trial will test a digital self-management support intervention to improve inhaler device technique and medication adherence, based on the COM-B Model, in people with COPD and comorbidities in the community. The PRISIMA Trial will rigorously test whether this intervention is effective in improving COPD-related quality of life, inhaler device technique, medication adherence for COPD and comorbidities, patient activation, exacerbations and hospital admissions due to COPD, and overall health-related quality of life. A qualitative and health economic evaluation will also be done to determine whether the intervention can be implemented in routine practice.
Interventions
The self-management intervention will be tailored and delivered to patients in the intervention group through a digital integrated care platform called CareMonitor. Following a co-design study including 1.5-hour focus groups with people with COPD and/or their carers, and healthcare professionals, key themes and stakeholder requirements will be identified. These components will be collated to inform the intervention toolkit. The co-design study is currently in the stage of participant recruitment
The self-management intervention will be tailored and delivered to patients in the intervention group through a digital integrated care platform called CareMonitor. Following a co-design study including 1.5-hour focus groups with people with COPD and/or their carers, and healthcare professionals, key themes and stakeholder requirements will be identified. These components will be collated to inform the intervention toolkit. The co-design study is currently in the stage of participant recruitment. Up to 8 online co-design focus groups, each with a maximum of 8 participants, will be conducted by March 2025; each participant will attend one focus group. In accordance with the 5 A’s (Ask, Assess, Advise, Assist, Arrange) model, the intervention will then be tailored based on individual patient demographics including severity of COPD, existing comorbidities, prescribed medication for COPD and comorbidities, level of activation, personal values and preferences, readiness to change and socio-economic status. A Motivational Interviewing approach will be used for tailoring and delivery of the intervention. Two Respiratory Nurse Educators will be trained to tailor and digitally deliver the intervention to patients in the intervention group via the CareMonitor platform through 3 one-to-one monthly health coaching sessions; each session will be approximately 30 minutes and include assessment of inhaler device technique and review of medication adherence. This will be followed by personalised fortnightly text messages and monthly follow-up calls for 3 months. The monthly follow-up phone calls, which will be approximately 10 minutes, are to check in with participants regarding their progress and discuss any challenges in keeping up their health behaviour following the health coaching sessions. Specific content of the sessions will be finalised after the co-design focus groups have been completed. The nurses will receive 2 hours of online training 4 weeks prior to first participant enrolment. The health coaching sessions will be conducted via video calls through CareMonitor; video calling is necessary for inhaler device technique to be assessed and corrected where necessary. For patients who require a Home Medicines Review for polypharmacy due to their COPD and comorbidities, the Respiratory Nurse Educators will organise a referral for a collaborative medication review by a prescribing physician, which will be conducted by an accredited pharmacist at the patient’s home.
Sponsors
Dr Sameera Ansari, UNSW Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients will be eligible to participate in the trial if they: i) have a spirometry-confirmed diagnosis of COPD, ii) have at least one other co-existing comorbidity, iii) are a resident of New South Wales, and iv) have access to an Android or iOS-enabled smartphone or tablet device with Internet connection.
Exclusion criteria
Patients will be excluded if they: i) are admitted in hospital at the time of recruitment; ii) have significant cognitive impairment; iii) are terminally ill; or iv) their carers (in case of NESB patients) do not have sufficient understanding of English to complete the study’s outcome measures and follow the self-management intervention.
Outcome results
None listed