Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000146796
Ethics application status
Approved
Date submitted
5/02/2013
Date registered
7/02/2013
Date last updated
23/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of a community-based medication counselling service on enhancing drug compliance among patients prescribed antihypertensive agents: a randomized controlled trial
Scientific title
Effectiveness of a community-based medication counselling service on enhancing drug compliance among patients prescribed antihypertensive agents: a randomized controlled trial
Secondary ID [1] 281901 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 288302 0
Condition category
Condition code
Cardiovascular 288646 288646 0 0
Hypertension
Public Health 288660 288660 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Standardized community-based medication counseling service by community pharmacists to enhance antihypertensive medication compliance will be delivered once at baseline, lasting for 10-20 minutes. This includes addressing participant's concern and uncertainties in taking medications, and reinforcing relevant knowledge on the chronic disease they are suffering from. Participants will receive a comprehensive pamphlet summarizing the content of medication counseling and motivated to enhance compliance to antihypertensive agents. During the 6-month study period, they will be offered free-of-charge telephone consultations with community pharmacists at 3 and 6-month after baseline.
Intervention code [1] 286470 0
Treatment: Other
Comparator / control treatment
This is an alternate arm to this study, in which participants assigned to the control group will be educated on the diagnoses of hypertension, their implications, and lifestyle factors that affect blood pressure by the physicians. This will be delivered once at baseline, lasting for 3-5 minutes.
Control group
Active

Outcomes
Primary outcome [1] 288803 0
Changes in the systolic and diastolic blood pressure as assessed by a random-zero sphygmomanometer in the right arm with an appropriately sized cuff.
Timepoint [1] 288803 0
Timepoint: baseline, 3 months and 6 months from baseline
Secondary outcome [1] 301029 0
Changes in compliance to antihypertensive medications as assessed by Morisky Medication Adherence Scores (MMAS).
Timepoint [1] 301029 0
Timepoint: baseline, 3 months and 6 months after baseline

Eligibility
Key inclusion criteria
1. Aged 18 years or older;
2. Taking long-term antihypertensive medications
3. Not previously received any community-based intervention programmes on medication adherence;
4. Assessed as having suboptimal compliance to the antihypertensive medication, as assessed by the Morisky self-reported adherence questionnaire.
5. Consent to adhere to the group of intervention they are allocated to.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Inability of the patient to communicate and understand Cantonese;
2. Medical conditions rendering the patient not mentally capable to participate in this study.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2013
Actual
15/09/2011
Date of last participant enrolment
Anticipated
Actual
20/12/2011
Date of last data collection
Anticipated
Actual
20/06/2012
Sample size
Target
300
Accrual to date
Final
318
Recruitment outside Australia
Country [1] 4852 0
Hong Kong
State/province [1] 4852 0

Funding & Sponsors
Funding source category [1] 286693 0
University
Name [1] 286693 0
CUHK Research Committee Funding (Direct Grant)
Country [1] 286693 0
Hong Kong
Primary sponsor type
Individual
Name
WONG Chi Sang, Martin
Address
Rm 407, 4/F, School of Public Health, Prince of Wales Hospital, Shatin, Hong Kong (Postcode:852)
Country
Hong Kong
Secondary sponsor category [1] 285462 0
None
Name [1] 285462 0
Address [1] 285462 0
Country [1] 285462 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288756 0
Joint Chinese University of Hong Kong- New Territories East Cluster Clinical Research Ethics Committee
Ethics committee address [1] 288756 0
Flat 3C, Block B, Staff Quarters, Prince of Wales Hospital, Shatin, Hong Kong (Postcode:852)
Ethics committee country [1] 288756 0
Hong Kong
Date submitted for ethics approval [1] 288756 0
Approval date [1] 288756 0
16/06/2011
Ethics approval number [1] 288756 0

Summary
Brief summary
This study aims to evaluate the effectiveness of a community-based medication counseling service in enhancing compliance to antihypertensive medications among patients in primary care settings. It is hypothesized that this intervention is effective in enhancing medication compliance among patients prescribed antihypertensive agents for the management of hypertension.
Trial website
Trial related presentations / publications
Martin CS Wong, Liu KQ, Wang HH, Lee CL, Kwan MW, Lee KW, Cheung Y, Lee GK, Morisky DE, Griffiths SM. Effectiveness of a Pharmacist-Led Drug Counseling on Enhancing Antihypertensive Adherence and Blood Pressure Control: A Randomized Controlled Trial. J Clin Pharmacol. 2013; 53(7): 753-761.
Public notes

Contacts
Principal investigator
Name 37650 0
Prof WONG Chi Sang, Martin
Address 37650 0
Rm 407, 4/F, School of Public Health, Prince of Wales Hospital, Shatin, Hong Kong (Postcode:852)
Country 37650 0
Hong Kong
Phone 37650 0
+852 22528782
Fax 37650 0
Email 37650 0
[email protected]
Contact person for public queries
Name 37651 0
Dr WANG Haoxiang, Harry
Address 37651 0
Rm 509, 5/F, School of Public Health, Prince of Wales Hospital, Shatin, Hong Kong (Postcode:852)
Country 37651 0
Hong Kong
Phone 37651 0
+852 22528703
Fax 37651 0
Email 37651 0
[email protected]
Contact person for scientific queries
Name 37652 0
Dr WANG Haoxiang, Harry
Address 37652 0
Rm 509, 5/F, School of Public Health, Prince of Wales Hospital, Shatin, Hong Kong (Postcode:852)
Country 37652 0
Hong Kong
Phone 37652 0
+852 22528703
Fax 37652 0
Email 37652 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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