Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000020987
Ethics application status
Approved
Date submitted
10/12/2019
Date registered
14/01/2020
Date last updated
23/06/2021
Date data sharing statement initially provided
14/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of health information distributed to people with knee osteoarthritis through community pharmacies: a feasibility study
Scientific title
The effect of health information distributed to people with knee osteoarthritis through community pharmacies on health perceptions, attitudes, and knowledge: a feasibility study
Secondary ID [1] 299811 0
HRC 19/675
Universal Trial Number (UTN)
U1111-1240-8926
Trial acronym
f-COPER (feasibility of Care for Osteoarthritis through Pharmacy Education and Referral)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 315189 0
Condition category
Condition code
Musculoskeletal 313504 313504 0 0
Osteoarthritis
Public Health 313920 313920 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Name: COPER booklet

The COPER booklet was specifically designed for this study. It contains information about osteoarthritis, explanation of common myths, and information about investigations, pain, other symptoms, optimising quality of life, movement and activity, diet and sleep, and seeking support. The COPER booklet integrates a biopsychosocial perspective and quotations from people who have knee osteoarthritis. A supporting website can be accessed using a link provided with the booklet. The website contains more detailed information, video content, links to research and other resources, and worksheets to aid development of an arthritis action plan.

The COPER booklet will be passively delivered to intervention arm participants without any further explanation. People who receive the COPER booklet will also be able to access the supporting website. People will receive the booklet once in a community pharmacy. People will be able to refer to the booklet at their own discretion for as long as they wish. Use of the booklet and website or adherence to the recommendations will not be monitored or assessed. The effect of the intervention over four weeks will be measured .
Intervention code [1] 316070 0
Rehabilitation
Intervention code [2] 316071 0
Lifestyle
Intervention code [3] 316072 0
Behaviour
Comparator / control treatment
Name: The Pharmaceutical Society of New Zealand Arthritis Fact Sheet

The Arthritis Fact Sheet (updated May 2019) contains a traditional biomedical explanation of osteoarthritis and a description of signs and symptoms, treatments (predominantly focusing on medicines), self care strategies, and contact details for arthritis support groups. The Arthritis Fact Sheet will be passively delivered to control arm participants without any further explanation. People will be able to refer to the fact sheet at their own discretion for as long as they wish. Use of the fact sheet or adherence to the recommendations will not be monitored or assessed.
Control group
Active

Outcomes
Primary outcome [1] 321963 0
Change in Brief Illness Perception Questionnaire (B-IPQ) score
Timepoint [1] 321963 0
Baseline, 4 weeks post randomisation (primary timepoint)
Secondary outcome [1] 376816 0
Change in knee pain when walking over the last week measured with the 11-point ordinal numeric pain rating scale (NPRS)
Timepoint [1] 376816 0
Baseline, 4 weeks post randomisation
Secondary outcome [2] 376817 0
Change in fear of movement measured with the Brief Fear of Movement Scale for Osteoarthritis
Timepoint [2] 376817 0
Baseline, 4 weeks post randomisation
Secondary outcome [3] 376818 0
Change in osteoarthritis knowledge measured with the Knee Osteoarthritis Knowledge Survey (KOAKS)
Timepoint [3] 376818 0
Baseline, 4 weeks post randomisation
Secondary outcome [4] 376822 0
Recruitment rate measured as the number of consumer participants recruited per pharmacy per week assessed with data from the study database
Timepoint [4] 376822 0
Baseline
Secondary outcome [5] 376823 0
Baseline data completeness assessed through a data audit of the proportion of baseline questionnaire items completed in the recruitment booklet
Timepoint [5] 376823 0
Baseline
Secondary outcome [6] 376824 0
Randomisation adherence will be assessed by cross-referencing the sequence of participant information pack distribution with the time of recruitment (recorded on the final page of the recruitment booklet) to assess whether information packs were distributed in the order dictated by the randomisation sequence.
Timepoint [6] 376824 0
Baseline
Secondary outcome [7] 376825 0
Loss to follow-up will be assessed through the proportion of participants who fail to return their 4-week follow-up survey using data from the study database.
Timepoint [7] 376825 0
Four weeks post-randomisation
Secondary outcome [8] 376826 0
Pharmacist perceptions measured through pharmacist focus groups. These audio-recorded semi-structured facilitated group interviews will last approximately 60 minutes.
Timepoint [8] 376826 0
At the completion of consumer participant recruitment
Secondary outcome [9] 376827 0
Consumer perceptions measured through telephone qualitative interviews. These audio-recorded, semi-structured interviews with open-ended questions will last approximately 30 minutes.
Timepoint [9] 376827 0
> 4 weeks post-randomisation
Secondary outcome [10] 378062 0
The proportion of participants whose knee osteoarthritis was diagnosed within pharmacy as part of the study, measured by being screened as being eligible and reporting that they have not previously being diagnosed as having osteoarthritis by a health professional.
Timepoint [10] 378062 0
Baseline
Secondary outcome [11] 378072 0
The proportion of participants who identify as being of Maori or a Pacifica ethnicity as recorded on their baseline questionnaire
Timepoint [11] 378072 0
Baseline

Eligibility
Key inclusion criteria
Pharmacists:
• New Zealand registered pharmacist
• Working in Canterbury
• Working in a community pharmacy that has agreed to participate in the study

Consumers:
• They are over 18 years of age
• They have knee pain that has been:
o diagnosed by a health professional as OA, or
o diagnosed within the pharmacy as OA as part of the recruitment visit, using
the NICE (National Institute for Health and Care Excellence) diagnostic criteria.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pharmacist participants will be excluded if they:
• do not participate in study training sessions.

Consumer participants will not be eligible for the study if they:
• have had a joint replacement in either knee at any time.
• have had knee surgery (other than joint replacement) in the last 12 months.
• are unable to read and write in English.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Consumer information (COPER booklets or Arthritis Fact Sheet information leaflets) will be contained within opaque coded envelopes. These envelopes will be padded and similar quantities of material will be included in both intervention and control envelopes to ensure group allocation cannot be identified without opening the envelope. The envelope will be sealed so that it cannot be opened without disrupting the seal or tearing the envelope.

Each pharmacy will have a master list with an ordered list of the sequence of codes to be given out. The coded envelopes (marked with the same codes on the pharmacy master list) will be sorted in the same order at the master list for ease of retrieval. The pharmacist will tick each sequential code off the list as they provide the coded envelope to a participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated permuted block randomisation (blocks of 12 equating to the expected recruitment in each pharmacy)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
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:

Sample size for the feasibility study (72 consumers total) is geared to address the recruitment feasibility assessment (target n=12 participants per pharmacy). This sample size will give reasonable estimation precision for belief change (the presumed mediator that would drive any clinical gains) by measuring changes in illness perceptions at 4 weeks. A sample size of 56 participants (n=28 per arm) would give 80% power to detect an 8 point difference on the B-IPQ (representing a 20% improvement from baseline score, assuming a standard deviation of 10.5 and using an alpha of 0.05). Recruiting a total of 72 consumers will thus provide important information about whether the intervention is likely to be able to alter psychological processes hypothesised to drive any intervention effect, which would be examined for clinical outcomes in the larger main RCT.

In addition, 12 consumers participants will be recruited to take part in qualitative interviews and 12 pharmacists will be recruited to take part in qualitative focus groups.

Analysis:

Statistical significance will be judged with an a of 0.05. All results will be reported as estimates of effect size (e.g. mean difference, risk ratio) with 95% confidence intervals (95% CI). All analyses will be conducted on an intention to treat basis (that is, data will be analysed according to the random allocation arm irrespective of receipt of treatment).

Consumer participant self-reported outcomes:

The B-IPQ, fear of movement, and K-OAKS analyses will be conducted on an intention-to-treat basis using linear mixed models to consider whether the intervention changes beliefs to the extent that it is plausible that health outcomes may be changed (as will be tested in the main RCT). These models will be adjusted for important baseline co-variates (age, gender, baseline knee pain, and duration of symptoms).

Recruitment:

Recruitment rates, participant characteristics, method of OA identification, method of finding out about the study will be analysed with descriptive statistics.

Qualitative data:

Qualitative data (pharmacist focus groups and consumer telephone interviews) will be transcribed verbatim, managed using N-Vivo software. Data will be analysed using Thematic Analysis. Pharmacist focus group and patient transcripts will be analysed separately. Data will be analysed iteratively to enable themes that emerge in early interviews can be explored in subsequent interviews.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/02/2020
Actual
18/02/2020
Date of last participant enrolment
Anticipated
3/07/2020
Actual
31/07/2020
Date of last data collection
Anticipated
28/08/2020
Actual
15/09/2020
Sample size
Target
84
Accrual to date
Final
76
Recruitment outside Australia
Country [1] 22106 0
New Zealand
State/province [1] 22106 0
Canterbury

Funding & Sponsors
Funding source category [1] 304271 0
Government body
Name [1] 304271 0
Health Research Council of New Zealand
Country [1] 304271 0
New Zealand
Primary sponsor type
Individual
Name
Dr Ben Darlow
Address
Department of Primary Health Care and General Practice
University of Otago, Wellington
23 Mein Street
Newtown
Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 304875 0
None
Name [1] 304875 0
Address [1] 304875 0
Country [1] 304875 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304728 0
Health and Disability Ethics Committees
Ethics committee address [1] 304728 0
Ethics committee country [1] 304728 0
New Zealand
Date submitted for ethics approval [1] 304728 0
03/10/2019
Approval date [1] 304728 0
19/12/2019
Ethics approval number [1] 304728 0
19/NTA/146

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

Contacts
Principal investigator
Name 98018 0
Dr Ben Darlow
Address 98018 0
Department of Primary Health Care and General Practice
University of Otago, Wellington
23 Mein St
Newtown
Wellington 6021
New Zealand
Country 98018 0
New Zealand
Phone 98018 0
+6449186051
Fax 98018 0
Email 98018 0
[email protected]
Contact person for public queries
Name 98019 0
Ben Darlow
Address 98019 0
Department of Primary Health Care and General Practice
University of Otago, Wellington
23 Mein St
Newtown
Wellington 6021
New Zealand
Country 98019 0
New Zealand
Phone 98019 0
+6449186051
Fax 98019 0
Email 98019 0
[email protected]
Contact person for scientific queries
Name 98020 0
Ben Darlow
Address 98020 0
Department of Primary Health Care and General Practice
University of Otago, Wellington
23 Mein St
Newtown
Wellington 6021
New Zealand
Country 98020 0
New Zealand
Phone 98020 0
+6449186051
Fax 98020 0
Email 98020 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a feasibility study and data will not be appropriate for sharing. We plan to share IPD from the full RCT that the feasibility study will inform.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5862Ethical approval  [email protected]



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFeasibility of a randomised controlled trial of two types of written information for people with knee osteoarthritis.2022https://dx.doi.org/10.1016/j.ocarto.2022.100254
N.B. These documents automatically identified may not have been verified by the study sponsor.