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Trial registered on ANZCTR


Registration number
ACTRN12624001464550
Ethics application status
Approved
Date submitted
18/11/2024
Date registered
16/12/2024
Date last updated
16/12/2024
Date data sharing statement initially provided
16/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomized Controlled Trial of Digital Self-Management Support for Inhaler Device Technique and Medication Adherence in People with Chronic Obstructive Pulmonary Disease (COPD) and other Chronic Health Conditions
Scientific title
A Pragmatic Randomized Controlled Clinical TRial to DIgitally Support Self-Management for Inhaler Device Technique and Medication Adherence among People with COPD and Comorbidities
Secondary ID [1] 307404 0
None
Universal Trial Number (UTN)
Trial acronym
PRISIMA Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease 335343 0
Multimorbidity 335344 0
Medication adherence 335345 0
Inhaler device technique 335346 0
Condition category
Condition code
Respiratory 331934 331934 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 329661 0
Behaviour
Intervention code [2] 329662 0
Treatment: Other
Intervention code [3] 329663 0
Prevention
Comparator / control treatment
Patients randomized to the control group of the trial will receive usual care. Usual care for the purposes of the PRISIMA trial is receiving healthcare in the community as needed for COPD and comorbidities.
Control group
Active

Outcomes
Primary outcome [1] 339536 0
COPD Assessment Test (CAT): This 8-item questionnaire is used to assess patients’ COPD-related quality of life and is a valid and reliable outcome measure (Cronbach’s alpha 0.79).
Timepoint [1] 339536 0
At Baseline and then at 6 and 12 (primary timepoint) months following commencement of the intervention (Session 1).
Secondary outcome [1] 440358 0
Accuracy of inhaler device technique: Device-specific inhaler checklists published by the National Asthma Council Australia and NPS MedicineWise will be used in this trial. A score of 1 is given for every step performed correctly by the patient and 0 if the patient omits a step or does it incorrectly. Since the number of steps varies between devices, inhaler technique will be reported as % of potential score.
Timepoint [1] 440358 0
At Baseline and then at 6 and 12 months following commencement of the intervention (Session 1).
Secondary outcome [2] 440359 0
Test of Adherence to Inhalers (TAI): This 12-item questionnaire is a highly reliable instrument (Cronbach’s alpha 0.86) to assess adherence to inhalers in patients with COPD or asthma.
Timepoint [2] 440359 0
At Baseline and then at 6 and 12 months following commencement of the intervention (Session 1).
Secondary outcome [3] 440360 0
Hill-Bone Medication Adherence Scale: This 9-item scale has broad application across various chronic health conditions, including COPD, for self-management of medication adherence.
Timepoint [3] 440360 0
At Baseline and then at 6 and 12 months following commencement of the intervention (Session 1).
Secondary outcome [4] 440361 0
Prescribed medication for COPD and comorbidities from patients’ Pharmaceutical Benefits Scheme (PBS) data. This will be assessed as a composite outcome.
Timepoint [4] 440361 0
At Baseline and then at 6 and 12 months following commencement of the intervention (Session 1).
Secondary outcome [5] 440362 0
Patient Activation Measure (PAM-13): The PAM is a valid and reliable 13-item instrument with high internal consistency (Cronbach’s alpha 0.87) for assessing patients’ self-efficacy of chronic disease.
Timepoint [5] 440362 0
At Baseline and then at 6 and 12 months following commencement of the intervention (Session 1).
Secondary outcome [6] 440363 0
Frequency of COPD exacerbations: COPD exacerbations will be identified using standardised criteria. Mild exacerbation: “During the last 6 months, how many times have you taken a course of antibiotics or steroids because your breathing was worse?” Severe exacerbation: “In the last 6 months, how many times were you admitted to hospital for one night or more because your breathing was worse?” (counted as 2 exacerbations if events are separated by more than 1 week).
Timepoint [6] 440363 0
At Baseline and then at 6 and 12 months following commencement of the intervention (Session 1).
Secondary outcome [7] 440364 0
Community-treated COPD exacerbations: Patients’ self-report of COPD exacerbations managed in the community during the study period.
Timepoint [7] 440364 0
At Baseline and then at 6 and 12 months following commencement of the intervention (Session 1).
Secondary outcome [8] 440365 0
Hospital admissions due to COPD as well as comorbidities during the study period from Medicare Benefits Schedule (MBS) Data. This will be assessed as a composite outcome.
Timepoint [8] 440365 0
At Baseline and then at 6 and 12 months following commencement of the intervention (Session 1).
Secondary outcome [9] 440366 0
Length of hospital stay: Length of patients’ hospital stay due to COPD and comorbidities during the study period from MBS data. This will be assessed as a composite outcome.
Timepoint [9] 440366 0
At Baseline and then at 6 and 12 months following commencement of the intervention (Session 1).
Secondary outcome [10] 440368 0
Health-related quality of life: The European Quality of Life-5 Dimensions 5 Levels (EuroQol EQ-5D-5L) questionnaire is a valid and reliable questionnaire for measuring health-related quality of life in cost-effectiveness analysis.
Timepoint [10] 440368 0
At Baseline and then at 6 and 12 months following commencement of the intervention (Session 1).
Secondary outcome [11] 440509 0
Health economic evaluation: Health outcomes and costs (outcomes) of implementing the tailored, self-management intervention will be compared. Costs and benefits generated by the intervention and usual care will be collected. Utilisation data will be collected from the corresponding MBS and PBS items, the National Hospital Cost Data Collection, and other relevant sources. Other data for the decision-analytic model and the budget impact analysis will be sourced from extant literature and publicly-available government data sources.

Timepoint [11] 440509 0
At 12 months following commencement of the intervention (Session 1).
Secondary outcome [12] 440510 0
Post-study interviews with healthcare providers: Qualitative interviews with up to 30 participating healthcare providers from the intervention arm will be conducted. After obtaining informed consent, the one-to-one interviews will be conducted by a researcher using a semi-structured interview guide examining perceptions of acceptability, feasibility and sustainability, as well as obtain their feedback on the intervention. The interviews will explore use and uptake of the intervention by healthcare providers and to what extent the CareMonitor platform assisted adoption of the intervention. Audio recordings of the interviews, which will each be about 30 minutes' duration, will be professionally transcribed, coded using NVivo and then thematically analysed.
Timepoint [12] 440510 0
At 6 months following commencement of the intervention (Session 1).
Secondary outcome [13] 440511 0
Post-study interviews with patients: Qualitative interviews with up to 30 patients from the intervention arm will be conducted. After obtaining informed consent, the one-to-one interviews will be conducted by a researcher using a semi-structured interview guide examining perceptions of acceptability, feasibility and sustainability, as well as obtain their feedback on the intervention. The interviews will explore how and why patients and carers used or abandoned tailored health education and opportunities for self-management of inhaler device technique and medication adherence during the trial, and also whether new health behaviours promoted by the self-management intervention were embedded within their daily life. Audio recordings of the interviews, which will each be about 30 minutes' duration, will be professionally transcribed, coded using NVivo and then thematically analysed.
Timepoint [13] 440511 0
At 6 months following commencement of the intervention (Session 1).

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomization of patients will be done centrally within the CareMonitor application; neither the research team nor the participants will be aware of group allocation prior to randomization.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomized in blocks of 4 to 6 via a computer-generated randomization program within the CareMonitor application to either the intervention or control group as they enrol in the trial.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size: The sample size calculation is based on between-group difference of 2.5 points in the COPD Assessment Test (CAT; a widely-used health status tool for COPD which is the primary endpoint for the trial). The mean change in CAT in a prior feasibility trial by the research team members on self-management of COPD in the context of multimorbidity in primary care was 2.5, which is greater than the minimum clinically significant difference of 2 points. To detect a between-group difference of 2.5 (SD 7.2) at 80% power, a sample size of 131 patients completing each arm of the trial is required. To allow for 20% loss to follow-up by 12 months, 164 patients per arm (N=328) patients will be recruited.

Quantitative: Linear or generalised linear models, depending on the distribution of the outcome variable, will be used to assess differences between groups. Mixed models with random effects will be used to compare changes between groups from baseline to follow-up. Dependent: CAT score, and other outcome measures; Independent: Group and demographic data will be entered as time-invariant covariates. Random effect: To manage missing data, mixed models assume the data are missing at random and incorporate baseline data in the model when the final measures are missing. Multiple imputation will be considered if missing data is substantial. All tests will be two-sided. Overall, p values <0.05 will be considered statistically significant.

Qualitative process evaluation: In accordance with the Normalisation Process Theory, acceptability, feasibility and sustainability of the intervention will be explored via post-study qualitative interviews with relevant stakeholders. At the health service level, the process evaluation will explore use and uptake of the intervention by participating healthcare providers and to what extent the CareMonitor platform assisted adoption of the intervention. At the patient level, the process evaluation will examine how and why patients and carers used or abandoned tailored health education and opportunities for self-management of inhaler device technique and medication adherence during the trial, and also whether new health behaviours promoted by the self-management intervention were embedded within their daily life. Semi-structured interviews will be conducted with up to 30 healthcare providers and 30 patients and carers from the intervention arm, with final number of interviews determined by data saturation. The interviews will be conducted from after 6 months post-intervention completion. Purposive sampling will be used at both provider and patient level to achieve maximum variation in key characteristics, including discipline and geographical location of participating providers; characteristics at the patient level will include age, gender, ethnicity, geographical location, number of comorbidities, COPD severity and change in the CAT score. Audio recordings of all qualitative interviews will be professionally transcribed, coded using NVivo and then thematically analysed.

Health economic evaluation: The health economic evaluation of the intervention will be guided by best practice, with an economic evaluation which will compare health outcomes and costs (outcomes) of implementing the tailored, self-management intervention. A within-trial cost-effectiveness analysis, a decision-analytic model, and a budget impact analysis will assess the economic value of the novel intervention. The results will demonstrate the net benefits and the expected cost of funding and implementing the intervention. An Australian health system perspective will be used to estimate the potential cost-effectiveness of implementation strategies assuming Australia-wide (population level) implementation as per the Medical Services Advisory Committee (MSAC) guidelines.

The health economic evaluation model will link estimates of clinical effectiveness, cost and uptake of the self-management intervention, and the disease modelling to estimate the overall impact of using the intervention compared to the usual care. The model time horizon will be a lifetime. The type of economic evaluation will be both a cost-effectiveness and cost-utility analysis, with outcomes (e.g., hospital admissions, length of hospital stay, adherence to inhalers) measured through cost per life-year gained and cost per quality-adjusted life year (QALY) gained. Finally, a budget impact analysis will be conducted to assess the fiscal impact on the Australian healthcare system with the potential implementation of the self-management intervention at a nationwide level. Comprehensive univariate and probabilistic sensitivity analyses will be conducted around cost variables to estimate robustness of results to plausible variations in key variables.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/11/2025
Actual
Date of last participant enrolment
Anticipated
31/08/2026
Actual
Date of last data collection
Anticipated
31/08/2027
Actual
Sample size
Target
328
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 311679 0
Government body
Name [1] 311679 0
Australian Government Department of Health Medical Research Future Fund (MRFF) Chronic Respiratory Conditions Grant
Country [1] 311679 0
Australia
Primary sponsor type
Individual
Name
Dr Sameera Ansari, UNSW Sydney
Address
Country
Australia
Secondary sponsor category [1] 313133 0
Individual
Name [1] 313133 0
Professor Helen Reddel, Woolcock Institute of Medical Research, Macquarie University
Address [1] 313133 0
Country [1] 313133 0
Australia
Other collaborator category [1] 283298 0
Charities/Societies/Foundations
Name [1] 283298 0
Lung Foundation Australia
Address [1] 283298 0
Country [1] 283298 0
Australia
Other collaborator category [2] 283299 0
Commercial sector/Industry
Name [2] 283299 0
CareMonitor
Address [2] 283299 0
Country [2] 283299 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311134 0
The University of New South Wales Committee C
Ethics committee address [1] 311134 0
Ethics committee country [1] 311134 0
Australia
Date submitted for ethics approval [1] 311134 0
30/08/2024
Approval date [1] 311134 0
08/10/2024
Ethics approval number [1] 311134 0
iRECS7241

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120062 0
Dr Sameera Ansari
Address 120062 0
School of Population Health, UNSW Sydney, Kensington, NSW 2052.
Country 120062 0
Australia
Phone 120062 0
+61452070047
Fax 120062 0
Email 120062 0
sameera.ansari@unsw.edu.au
Contact person for public queries
Name 120063 0
Dr Sameera Ansari
Address 120063 0
School of Population Health, UNSW Sydney, Kensington, NSW 2052.
Country 120063 0
Australia
Phone 120063 0
+61452070047
Fax 120063 0
Email 120063 0
sameera.ansari@unsw.edu.au
Contact person for scientific queries
Name 120064 0
Dr Sameera Ansari
Address 120064 0
School of Population Health, UNSW Sydney, Kensington, NSW 2052.
Country 120064 0
Australia
Phone 120064 0
+61452070047
Fax 120064 0
Email 120064 0
sameera.ansari@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The deidentified quantitative dataset of this trial will be lodged in the University of New South Wales’ data repository.
When will data be available (start and end dates)?
The data will be available immediately after publication; no end date.
Available to whom?
The data will be available to interested stakeholders such as clinicians, researchers and health organisations.
Available for what types of analyses?
The data will be available for the purpose of secondary analyses of clinical trial data such as meta-analyses.
How or where can data be obtained?
The data can be obtained upon request from the primary sponsor of the study, Dr Sameera Ansari, via email (sameera.ansari@unsw.edu.au)


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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