NCT06273761

Brief Summary

Medication management services (MMS) is a pharmacist-led service of optimizing the medication use and health outcomes, by promoting medication safety and enhancing the ability in self-management of health and diseases of patients and their caregivers. Yet, only limited evidence on the implementation of MMS service in Hong Kong is available. The goal of this clinical trial is to evaluate the cost effectiveness and effects of implementing MMS in community pharmacies owned by 8 non-government organizations (NGOs) in Hong Kong on humanistic and clinical outcomes in patients with hypertension and/or type II diabetes mellitus. The clinical trial aims to look into the following aspects:

  • To evaluate the perception and satisfaction of patients on MMS service
  • To investigate whether MMS could improve patients' adherence to their medication regimen, health-related quality of life, health outcomes and health service utilization, as well as their ability to understand and cope with their illness and drug-related problems
  • To identify and categorize the types of drug-related problems identified during MMS
  • To evaluate the cost-effectiveness of implementing MMS in community pharmacies MMS services will be rolled out in a total of 8 NGO community pharmacies progressively (2 pharmacies per phase) in 4 successive phases. Participants will complete the questionnaires at the following time points throughout the trial, namely 1) during recruitment, 2) baseline (1 month before MMS), 3) 3 months after MMS begins, 4) 12 months after MMS begins, and 5) 24 months after MMS begins. Researchers will compare the results of questionnaires conducted at different time points to identify the potential changes in the effects of MMS. Furthermore, researchers will link up the electronic health records of the participants and identify the potential changes in the health outcomes and health service utilizations after receiving MMS.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
640

participants targeted

Target at P75+ for not_applicable

Timeline
12mo left

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress70%
Feb 2024May 2027

First Submitted

Initial submission to the registry

January 9, 2024

Completed
28 days until next milestone

Study Start

First participant enrolled

February 6, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 23, 2024

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

February 23, 2024

Status Verified

January 1, 2024

Enrollment Period

2.5 years

First QC Date

January 9, 2024

Last Update Submit

February 21, 2024

Conditions

Keywords

Medication Management ServiceCommunity pharmacy service

Outcome Measures

Primary Outcomes (1)

  • Medication adherence

    Medication adherence will be assessed by the Medication Adherence Report Scale (MARS-5) which consists of a total of 5 items and is used to assess patient's adherence to their medications. Participants rate items on a 5-point scale. The score range for MARS-5 is 5-25, higher score indicates better adherence to take medications.

    Medication adherence will be assessed at 5 time points, namely 1) during recruitment, 2) baseline (1 month before MMS), 3) 3 months after MMS begins, 4) 12 months after MMS begins, and 5) 24 months after MMS begins.

Secondary Outcomes (10)

  • Additional health service utilization

    Through study completion, an average of 1 year

  • Patient perception and satisfaction

    Patient perception and satisfaction will be assessed at 3 time points, namely 1) 3 months after MMS begins, 2) 12 months after MMS begins, and 3) 24 months after MMS begins.

  • Patient perceived sensitivity to medicines

    Patient perceived sensitivity to medicines will be assessed at 3 time points, namely 1) 3 months after MMS begins, 2) 12 months after MMS begins, and 3) 24 months after MMS begins.

  • Social impact

    Social impact will be assessed at 5 time points, namely 1) during recruitment, 2) baseline (1 month before MMS), 3) 3 months after MMS begins, 4) 12 months after MMS begins, and 5) 24 months after MMS begins.

  • Health-related quality of life

    Health-related quality of life will be assessed at 5 time points, namely 1) during recruitment, 2) baseline (1 month before MMS), 3) 3 months after MMS begins, 4) 12 months after MMS begins, and 5) 24 months after MMS begins.

  • +5 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Participants who join the trial will have have a control period (no intervention) of 3 to 12 months before receiving medication management service (MMS) at 8 NGO community pharmacies. Since there are 8 NGO community pharmacies, 2 NGO community pharmacies will start delivering MMS by phase at 3, 6, 9 and 12 month intervals. Therefore, all participants who join the trial will receive MMS by month 12 from recruitment date. During the MMS service, pharmacists will review the participants' medication history and conduct medication reconciliation, refer them to doctors for reviewing the prescribing decision if necessary, as well as provide education and lifestyle advice on medication management.

Behavioral: Medication Management Service (MMS)

Control

NO INTERVENTION

Participants who join the trial will have have a control period of 3 to 12 months before receiving medication management service (MMS) at 8 NGO community pharmacies. Participants will have no MMS intervention during the control period. Since there are 8 NGO community pharmacies, two NGO community pharmacies will start delivering MMS by phase at 3, 6, 9 and 12 month intervals. Therefore, all participants who join the trial will receive MMS by month 12 from recruitment date.

Interventions

Medication Management Service (MMS) is a service delivered by community pharmacists aiming at helping patients resolve their medication therapy problems (MTPs) by carrying out medication reconciliation, provision of education about their medication regimen, and also providing professional pharmacological advice to patients.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 18 years or above
  • diagnosed with Type 2 diabetes mellitus and/or hypertension
  • having regular follow-up on Type 2 diabetes mellitus and/or hypertension at Hospital Authority
  • no A\&E admission/hospitalization in the past 3 months
  • no recent changes in medication regimen in the past 3 months
  • polypharmacy (taking 5 or more chronic medications)
  • using at least 1 high-risk medication (Anticoagulants, Oral hypoglycaemics, Insulins, psychotropic medications or immunosuppressants)
  • able to communicate in Cantonese and/or English

You may not qualify if:

  • aged below 18
  • unable to give informed consent
  • unable to communicate in Cantonese and/or English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Aberdeen Kai-Fong Welfare Association A-Lively Community Pharmacy

Hong Kong, Hong Kong

RECRUITING

Health In Action Community Pharmacy

Hong Kong, Hong Kong

RECRUITING

Hong Kong Sheng Kung Hui Welfare Council Community Pharmacy

Hong Kong, Hong Kong

RECRUITING

PHARM+ Haven of Hope Community Pharmacy

Hong Kong, Hong Kong

RECRUITING

PHARM+ Pok Oi Hospital Community Pharmacy

Hong Kong, Hong Kong

RECRUITING

PHARM+ St. James' Settlement Community Pharmacy

Hong Kong, Hong Kong

RECRUITING

PHARM+ The Lok Sin Tong Community Pharmacy

Hong Kong, Hong Kong

RECRUITING

PHARM+ YWCA Community Pharmacy

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Medication AdherenceDiabetes Mellitus, Type 2Hypertension

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Ian Chi Kei Wong, PhD

CONTACT

Eric Yuk Fai Wan, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 9, 2024

First Posted

February 23, 2024

Study Start

February 6, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

February 23, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations