Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001839291
Ethics application status
Approved
Date submitted
6/11/2018
Date registered
12/11/2018
Date last updated
16/04/2021
Date data sharing statement initially provided
12/11/2018
Date results provided
16/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot trial of health coaching in community pharmacy: the outcomes for patients with hypertension.
Scientific title
A pilot trial of health coaching in community pharmacy: the outcomes for patients with hypertension.
Secondary ID [1] 296533 0
Nill Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 310312 0
Condition category
Condition code
Cardiovascular 309048 309048 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Health coaching is the study intervention.
Health coaching is a more patient centred approach to health care, it involves the patient telling the pharmacist how they want to manage and improve their health. It is the role of the pharmacist to help the patient set goals and plans to improve their health, in comparison to standard care provided within the community pharmacy. Health coaching involves regular scheduled visits with the pharmacist in order to monitor the patient’s health progress as well as to motivate the patient and address any heath concerns.
Initially, community pharmacies in the Melbourne metropolitan area will be recruited for this study. These Pharmacies have been recruited by the research student.
Pharmacies must have employed a pharmacist willing to be trained in the health coaching. The research student will provide the pharmacists with the study protocol, study documents as well as the pharmacist PICF to read through. Pharmacists will be advised to contact the research student if they have any questions and/ or would like to consent to participate in the trial. It is the role of the research student to consent the pharmacists and ensure that they meet the study inclusion criteria.
Pharmacists that agree to participate in the study must sign the study consent form. Once consented, the pharmacists will receive health coach training by the research student under the guidance of her supervisors. The pharmacists will also receive information and training on how to recruit and consent patients for the trial.
The consented pharmacists will be assigned the role of a study investigator once they have consented to participate in the trial.
Assigning pharmacists with this role is necessary as they will be required to recruit patients with poorly controlled hypertension to participate in the trial and receive health coaching.
Patients that have their blood pressure regularly checked at the pharmacy can opt to have the readings documented in electronic pharmacy records. Patients will often request a copy of their records before seeing their GP or for their own records. The pharmacists will approach patients in their pharmacy that have poorly controlled hypertension. The pharmacist may recognise and approach patients that they recognise to have poorly controlled hypertension through these pharmacy records. Other patients that are taking antihypertensive could also be approached about the trial. Recruitment posters will also be place in pharmacy to assist with the recruitment of participants for the trial. When approaching potential participants about the trial pharmacists should provide patients with a brief overview of the trial in lay terms and also provide interested patients with a patient PICF to take home and read.
Pharmacists should follow-up patients to whom they have provided the PICF at their next visit to the pharmacy, unless the patient is willing to consent sooner.
Pharmacists should then consent patients to participate in the trial. These patients will then be screened by the pharmacist to ensure that they meet the inclusion/ exclusion criteria for the trial. Patients that meet study requirements can then receive health coaching at a time negotiated with the pharmacist.
The pharmacist will consent and screen patients. Patients that have consented and screened, but do not meet the inclusion criteria for the study will be excluded from the trial. Pharmacists will need to consent and screen patients until they have at least 10 patients per site that meet the inclusion criteria for the study.
Pharmacists will document on a record sheet provided by research team, the patient name, date approached about study and provided with PICF, and well as the date they followed up with the patient and the date the patient consented. This document will allow pharmacist to keep track of who they have approached about the study and who and when they need to follow up with the patient with regards to participation the trial. This document is to be kept confidential.
The participants that meet the inclusion criteria for the trial will receive three health coaching sessions 45 minutes in length one-on-one with the pharmacist health coach. These sessions will be scheduled one month apart. The study will also involve a post study visit. In general the patients and pharmacist will need to commit 6 months to participate in the study.
Intervention code [1] 312840 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308007 0
The primary outcome is the change in a participants’ blood pressure from baseline to end of trial as a result of the health coaching in intervention.
Blood pressure will be measured using an automatic blood pressure monitor.
Timepoint [1] 308007 0
Three months after first session with pharmacist.
Secondary outcome [1] 353631 0
Secondary outcomes are the change in participants understanding of their medications. Assessed using Adherence to refills and medications scale (ARMS).
Timepoint [1] 353631 0
Three months after the first visit with the pharmacist
Secondary outcome [2] 353785 0
Secondary outcomes are the change in participants adherence to their anti-hypertensive medications. Assessed using Adherence to refills and medications scale (ARMS) as well as open-ended qualitative interviews with the pharmacist health coach.
Timepoint [2] 353785 0
Three months after the first visit with the pharmacist
Secondary outcome [3] 353786 0
Secondary outcomes are the change in participants reflections and perceptions. Assessed using open-ended qualitative interviews with the pharmacist health coach.
Timepoint [3] 353786 0
Three months after the first visit with the pharmacist
Secondary outcome [4] 353787 0
secondary outcomes also include the change in the health coaches’ reflections during and at the completion of health coaching.Assessed using open-ended qualitative interviews conducted by the researchers.
Timepoint [4] 353787 0
At the completion of the trial

Eligibility
Key inclusion criteria
Key inclusion criteria:
• Age/sex: men and women aged greater than or equal to 18 years
• Diagnosed with essential hypertension
• BP eligibility: systolic and/or diastolic hypertension (equal to 140/90 mmHg) despite compliance with at least one antihypertensive drug
• Understands English
• Non/ex-smoker
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Key exclusion criteria:
• Age/sex: men and women aged less than 18 years
• MI, stroke or angina within 6 months
• Pregnancy
• Current smoker
• Secondary hypertension, cardiovascular (CVD) disorders (unstable angina pectoris, heart failure, life-threatening arrhythmia, nephropathy, and grade III-IV retinopathy), intolerance to ambulatory blood pressure (BP) monitoring (ABPM)
• Inability to communicate and comply with all trial requirements
• Requiring diuretics, CCB, ACEI or a-blockers for reasons other than hypertension
• Work/life commitments that may interfere with trial requirement

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/01/2019
Actual
10/01/2019
Date of last participant enrolment
Anticipated
28/02/2019
Actual
10/07/2019
Date of last data collection
Anticipated
31/12/2019
Actual
4/11/2019
Sample size
Target
21
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 301113 0
University
Name [1] 301113 0
RMIT UNIVERSITY
Country [1] 301113 0
Australia
Primary sponsor type
Individual
Name
Prof Ieva Stupans
Address
RMIT UNIVERSITY
264 Plenty Rd, Bundoora VIC 3083
Country
Australia
Secondary sponsor category [1] 300730 0
None
Name [1] 300730 0
Address [1] 300730 0
Country [1] 300730 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301863 0
Royal Melbourne Institute of Technology Human Research Ethics Committee
Ethics committee address [1] 301863 0
Ethics committee country [1] 301863 0
Australia
Date submitted for ethics approval [1] 301863 0
08/11/2018
Approval date [1] 301863 0
21/12/2018
Ethics approval number [1] 301863 0

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

Contacts
Principal investigator
Name 88362 0
Prof Ieva Stupans
Address 88362 0
RMIT UNIVERSITY
264 Plenty Rd, Bundoora VIC 3083
Country 88362 0
Australia
Phone 88362 0
+61 3 9925 7942
Fax 88362 0
Email 88362 0
[email protected]
Contact person for public queries
Name 88363 0
Ieva Stupans
Address 88363 0
RMIT UNIVERSITY
264 Plenty Rd, Bundoora VIC 3083
Country 88363 0
Australia
Phone 88363 0
+61 3 9925 7942
Fax 88363 0
Email 88363 0
[email protected]
Contact person for scientific queries
Name 88364 0
Ieva Stupans
Address 88364 0
RMIT UNIVERSITY
264 Plenty Rd, Bundoora VIC 3083
Country 88364 0
Australia
Phone 88364 0
+61 3 9925 7942
Fax 88364 0
Email 88364 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
Initially when information is collected about the participants it will be recorded in the case report form kept within a folder specific to the patient. At this point information will be identifiable. Privacy of this identifiable material will be maintained, whereby all participant folders are to be kept in a secure location within the pharmacy. The same will also apply to audio recordings, which will be kept on a password protected computer.
Participants will be allowed access to their results. At the completion of the trial de identified data may used for the purpose of presentations and research papers, as such trial data will only be made available to the public in this format.


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
SourceTitleYear of PublicationDOI
EmbaseA pharmacist health coaching trial evaluating behavioural changes in participants with poorly controlled hypertension.2021https://dx.doi.org/10.1186/s12875-021-01385-0
N.B. These documents automatically identified may not have been verified by the study sponsor.