ANZCTR - Registration

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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]

Nill Known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Hypertension

Condition category

Condition code

Cardiovascular

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]

Treatment: Other

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Three months after first session with pharmacist.

Secondary outcome [1]

Secondary outcomes are the change in participants understanding of their medications. Assessed using Adherence to refills and medications scale (ARMS).

Timepoint [1]

Three months after the first visit with the pharmacist

Secondary outcome [2]

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]

Three months after the first visit with the pharmacist

Secondary outcome [3]

Secondary outcomes are the change in participants reflections and perceptions. Assessed using open-ended qualitative interviews with the pharmacist health coach.

Timepoint [3]

Three months after the first visit with the pharmacist

Secondary outcome [4]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

RMIT UNIVERSITY

Address [1]

264 Plenty Rd, Bundoora VIC 3083

Country [1]

Australia

Primary sponsor type

Individual

Name

Prof Ieva Stupans

Address

RMIT UNIVERSITY
264 Plenty Rd, Bundoora VIC 3083

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Melbourne Institute of Technology Human Research Ethics Committee

Ethics committee address [1]

124 La Trobe St, Melbourne VIC 3000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

08/11/2018

Approval date [1]

21/12/2018

Ethics approval number [1]

Summary

Brief summary

In this study pharmacists trained in health coaching will provide coaching to patients with poorly controlled hypertension. Patients will receive three health coaching sessions with the pharmacist. The aim of this project is to determine if there is an association between health coaching provided by a community pharmacists and an improvement in blood pressure and medication adherence. The project will also look at the change in patients health behaviours through the study through assessing patient’s stage of change from a stages of change chart. The project will also look at the opinions and attitudes of the pharmacist health coaches throughout the study as well as those of the patients. An improvement in patients’ blood pressure is also expected at the end of the study as well as their health behaviours. It is also expected that patients will have an improved understanding of high blood pressure and its management.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Ieva Stupans

Address

RMIT UNIVERSITY
264 Plenty Rd, Bundoora VIC 3083

Country

Australia

Phone

+61 3 9925 7942

Fax

ieva.stupans@rmit.edu.au

Contact person for public queries

Name

Ieva Stupans

Address

RMIT UNIVERSITY
264 Plenty Rd, Bundoora VIC 3083

Country

Australia

Phone

+61 3 9925 7942

Fax

ieva.stupans@rmit.edu.au

Contact person for scientific queries

Name

Ieva Stupans

Address

RMIT UNIVERSITY
264 Plenty Rd, Bundoora VIC 3083

Country

Australia

Phone

+61 3 9925 7942

Fax

ieva.stupans@rmit.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	A pharmacist health coaching trial evaluating behavioural changes in participants with poorly controlled hypertension.	2021	https://dx.doi.org/10.1186/s12875-021-01385-0

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically