Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000568718
Ethics application status
Approved
Date submitted
25/01/2022
Date registered
13/04/2022
Date last updated
15/09/2023
Date data sharing statement initially provided
13/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised Controlled Trial of Self-Management Support for Primary Care Patients with Chronic Obstructive Pulmonary Disease (COPD) and other Chronic Health Conditions
Scientific title
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
Secondary ID [1] 305995 0
None
Universal Trial Number (UTN)
Trial acronym
APCOM Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease 324621 0
Multimorbidity 324622 0
Condition category
Condition code
Respiratory 322074 322074 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 322394 0
Behaviour
Intervention code [2] 322944 0
Treatment: Other
Intervention code [3] 323236 0
Prevention
Comparator / control treatment
Patients in the control group will receive usual care. Usual care for the purpose of the APCOM Trial includes regular healthcare consultations by the patients with their GP and PN, as well as other providers outside the general practice for COPD and other health conditions. GPs and PNs in the control group will be provided a copy of the COPD-X Concise Guide for Primary Care.
Control group
Active

Outcomes
Primary outcome [1] 329840 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] 329840 0
At Baseline and then at 6 and 12 months following commencement of the intervention (Session 1).
Secondary outcome [1] 404022 0
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 [1] 404022 0
At Baseline and then at 6 and 12 months following commencement of the intervention (Session 1).
Secondary outcome [2] 404025 0
COPD Knowledge Questionnaire (COPD-Q): This is a valid and reliable 13-item tool used to assess COPD knowledge and has good internal consistency (Cronbach’s alpha 0.72).
Timepoint [2] 404025 0
At Baseline and then at 6 and 12 months following commencement of the intervention (Session 1).
Secondary outcome [3] 404026 0
Patient Activation Measure (PAM): 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 [3] 404026 0
At Baseline and then at 6 and 12 months following commencement of the intervention (Session 1).
Secondary outcome [4] 404027 0
Smoking status - self report by participants.
Timepoint [4] 404027 0
At Baseline and then at 6 and 12 months following commencement of the intervention (Session 1).
Secondary outcome [5] 404028 0
COPD medication: This will be recorded for evaluation in agreement with the COPD-X Concise Guide for Primary Care.
Timepoint [5] 404028 0
At Baseline and then at 6 and 12 months following commencement of the intervention (Session 1).
Secondary outcome [6] 404029 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 [6] 404029 0
This outcome measure will be collected by the PNs only for patients in the intervention group during the first session (baseline) and 10 weeks post-intervention commencement.
Secondary outcome [7] 404030 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 [7] 404030 0
This outcome measure will be collected by the PNs only for patients in the intervention group during the first session (baseline) and 10 weeks post-intervention commencement.
Secondary outcome [8] 404031 0
Attendance at pulmonary rehabilitation: The number of patients who report attending a pulmonary rehabilitation program in the previous 6 months.
Timepoint [8] 404031 0
At Baseline and then at 6 and 12 months following commencement of the intervention (Session 1).
Secondary outcome [9] 404032 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 [9] 404032 0
At Baseline and then at 6 and 12 months following commencement of the intervention (Session 1).
Secondary outcome [10] 408343 0
Composite healthcare usage and intervention costs: This includes estimation of cost of the intervention (education, device and personnel costs), usual care and condition-specific health care utilisation including medications costs, emergency and/or hospital admissions for an exacerbation from the electronic discharge summary sent to the practice. Information on usual care and condition-specific costs will be extracted from the patients’ electronic medical record. Data on the intervention costs will include PN time for attending training, conducting the health coaching sessions and providing telephone support, production of resource materials for the intervention and patient toolkit for participants allocated to the intervention group. For patients allocated to the control group, only medication and health care utilisation costs will be collected from their electronic medical records.
Timepoint [10] 408343 0
At 12 months following commencement of the intervention (Session 1).
Secondary outcome [11] 408344 0
Post-study interviews with PNs: Qualitative interviews with up to 15 PNs from the intervention arm will be conducted. After obtaining informed consent, the one-to-one interviews will be conducted by a researcher over the telephone using a semi-structured interview guide examining the PNs' perceptions of acceptability, feasibility and sustainability, as well as obtain their feedback on the program. 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 [11] 408344 0
The PN interviews will be conducted after completion of the health coaching sessions of the program and three monthly follow-up phone calls.
Secondary outcome [12] 408345 0
Post-study interviews with GPs: Qualitative interviews with up to 15 GPs from the intervention arm will be conducted. After obtaining informed consent, the one-to-one interviews will be conducted by a researcher over the telephone using a semi-structured interview guide examining the GPs' perceptions of acceptability, feasibility and sustainability, as well as obtain their feedback on the program. 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] 408345 0
The GP interviews will be conducted after completion of the health coaching sessions of the program and three monthly follow-up phone calls.
Secondary outcome [13] 408346 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 over the telephone using a semi-structured interview guide exploring the patients' experience of having participated in the program, adoption and abandonment of self-management behaviours, rationale for not completing the program (if applicable), as well as their feedback on the program. 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] 408346 0
The Patient interviews will be conducted after completion of the health coaching sessions of the program and three monthly follow-up phone calls.

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

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)
Randomisation of practices will be conducted by a statistician independent from the study team using a computer-generated randomisation program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
General practices and their patients will be allocated to either the intervention or control group by simple randomisation using a randomisation table created by computer software in blocks of 4 to 6.
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:

Quantitative: The trial will be conducted in 46 general practices (23 practices each in the control and intervention arms, each practice recruiting 8 patients) across Australia. The sample size calculation is based on between group difference of 2.5 in the COPD Assessment Test (CAT; a widely-used health status too for COPD which is the primary endpoint for the trial). The mean change in CAT in the pilot study was 2.5 which is greater than the published minimum clinically important difference of 25. To detect a between-group difference of 2.5 (SD 7.2) with 80% power based on an intra-cluster correlation coefficient (ICC) of 0.01, and a resultant design effect of 1.07 for a cluster size of 8 patients from each practice, a sample size of 142 patients completing each arm is required. To allow for 20% loss to follow-up by 18 months, 178 patients per group will be recruited.

Qualitative: For the qualitative process evaluation of the trial, semi-structured interviews with up to 15 PNs. 15 GPs and 30 patients from the intervention arm will be conducted. The final number of interviews will be determined by data saturation.

Data analysis:

Quantitative data analysis: Linear or generalised linear models, depending on the distribution of the outcome variable, will be used to assess differences between groups while adjusting for the clustered nature of the data. 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 if baseline group differences are observed despite randomisation. Random effect: GP practice. 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. For cost utility analysis, the QALYs experienced by each patient from baseline to 12 months will be calculated. Differences in baseline characteristics will be investigated and, if necessary, regression methods will be used to control them. An incremental cost utility ratio (ICUR) will be calculated using the cost per gained QALY. The ICUR will be calculated by dividing the incremental costs by the incremental QALYs. The analysis will be guided by ICUR Acceptability Curves to determine if the self-management program is cost-effective at a different cost per QALY threshold. All tests will be two-sided. Overall, p values <0.05 will be considered statistically significant.

Cost effectiveness: A cost-utility analysis will be used to determine the cost-effectiveness of the self-management intervention compared to usual care. Total healthcare usage and intervention costs will be measured. The net cost will be compared with the gains in QALYs, and the cost per QALY gained will be estimated. The EuroQoL EQ-5D-5L will be used to generate utility scores at baseline and follow ups (6 and 12 months) for each individual patient. The cost will include cost of the intervention (education, device and personnel), usual care and condition-specific health care utilisation including medications costs, emergency and/or hospital admissions for an exacerbation from the electronic discharge summary sent to the practice. Information on usual care and condition-specific costs will be extracted from the patients’ medical records at 12 months. Data on the intervention costs will include PN time, telephone support, resource materials for the intervention and patient prompts throughout the trial. Data will also be collected on set-up and implementation costs such as staff training workshops and monitoring.

Qualitative process evaluation: Adoption, including acceptability, feasibility and sustainability of the intervention will be explored. At the practice level, the process evaluation will explore the uptake in practices and to what extent the PN and GP training and support assisted adoption of the intervention. At the patient level, the process evaluation will examine how and why patients use or abandon opportunities for self-management care during the trial, and also whether self-care behaviours promoted by the self-management program are embedded within the life of the participants. Qualitative descriptive evaluation will be done using semi-structured interviews with up to 15 PNs, 15 GPs and 30 patients from the intervention arm. Interviews will be performed from the 6th month follow-up point after intervention completion. Purposive sampling will be used at practice and patient level to achieve maximum variation in key characteristics. At the practice level, these include practice size and geographical location; characteristics at the patient level include geographical location, gender, ethnicity, age, number of comorbidities, COPD severity and change in the CAT score. Audio recordings of the qualitative interviews with the PNs, GPs and patients will be professionally transcribed, coded using NVivo and then thematically analysed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/04/2022
Actual
24/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
356
Accrual to date
80
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 310334 0
Government body
Name [1] 310334 0
Australian Government Department of Health Medical Research Future Fund (MRFF) Primary Health Care Research Initiative
Country [1] 310334 0
Australia
Primary sponsor type
Individual
Name
Professor Nicholas Zwar, Bond University
Address
Faculty of Health Sciences and Medicine, Bond University, 14 University Dr, Robina, QLD 4229.
Country
Australia
Secondary sponsor category [1] 311475 0
Individual
Name [1] 311475 0
Dr Sameera Ansari, UNSW Sydney
Address [1] 311475 0
School of Population Health, Samuels Building, F25, Samuel Terry Ave, Kensington, NSW 2033.
Country [1] 311475 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309994 0
Bond University Human Research Ethics Committee
Ethics committee address [1] 309994 0
Bond University, 14 University Dr, Robina, QLD 4229.
Ethics committee country [1] 309994 0
Australia
Date submitted for ethics approval [1] 309994 0
11/11/2021
Approval date [1] 309994 0
17/12/2021
Ethics approval number [1] 309994 0
SA02927

Summary
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.
Trial website
Trial related presentations / publications
Public notes
The first general practice signed up for the trial on 18th May 2022. As of 3rd April 2023, 12 general practices and 18 patients have consented to participate in the trial.

Contacts
Principal investigator
Name 116110 0
Prof Nicholas Zwar
Address 116110 0
Faculty of Health Sciences and Medicine, Bond University, 14 University Dr, Robina, QLD 4229.
Country 116110 0
Australia
Phone 116110 0
+61755955499
Fax 116110 0
Email 116110 0
nzwar@bond.edu.au
Contact person for public queries
Name 116111 0
Prof Nicholas Zwar
Address 116111 0
Faculty of Health Sciences and Medicine, Bond University, 14 University Dr, Robina, QLD 4229.
Country 116111 0
Australia
Phone 116111 0
+61755955499
Fax 116111 0
Email 116111 0
nzwar@bond.edu.au
Contact person for scientific queries
Name 116112 0
Prof Nicholas Zwar
Address 116112 0
Faculty of Health Sciences and Medicine, Bond University, 14 University Dr, Robina, QLD 4229.
Country 116112 0
Australia
Phone 116112 0
+61755955499
Fax 116112 0
Email 116112 0
nzwar@bond.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 Bond University’s research 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, Prof Nicholas Zwar via email (nzwar@bond.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.

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