Medication AdherenceNCT06273761
Evaluation of Medication Management Service
A study testing Medication Management Service (MMS) in people with Medication Adherence and Medication Safety, run by The University of Hong Kong at 8 sites in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence, Medication Safety, Diabetes Mellitus, Type 2
- What is being tested?
- Medication Management Service (MMS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 8 sitesHong Kong
- Study dates
- 6 Feb 2024to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- aged below 18
- unable to give informed consent
- unable to communicate in Cantonese and/or English
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Hong Kong8 sites, 8 recruiting
- Recruiting
Aberdeen Kai-Fong Welfare Association A-Lively Community Pharmacy
Hong Kong
Kam Kit Mak, 3550 5460, kennethmak.kk@aka.org.hk
- Recruiting
Health In Action Community Pharmacy
Hong Kong
Ka Shing Mak, 3612 9515, simonmak@hia.org.hk
- Recruiting
Hong Kong Sheng Kung Hui Welfare Council Community Pharmacy
Hong Kong
Sze Yin Lee, 2116 0382, wtspharm@skhwc.org.hk
- Recruiting
PHARM+ Haven of Hope Community Pharmacy
Hong Kong
Mei Lun Bruce Tsui, 2156 2280, compharm@hohcs.org.hk
- Recruiting
PHARM+ Pok Oi Hospital Community Pharmacy
Hong Kong
Kwok leung Li, 59506880, ylcppharm1@pokoi.org.hk
Anson Tsz Kin Leung, ylcppharic@pokoi.org.hk
- Recruiting
PHARM+ St. James' Settlement Community Pharmacy
Hong Kong
Kit Sze Chan, 2835 4320, ks.chan@sjs.org.hk
- Recruiting
PHARM+ The Lok Sin Tong Community Pharmacy
Hong Kong
William Ho Ching Yuen, 21872780, tpcp@loksintong.org
- Recruiting
PHARM+ YWCA Community Pharmacy
Hong Kong
Sui Hong Ho, 2511 6020, jackyho@ywca.org.hk
About this study
Official title: Primary Care Community Pharmacy Project: Evaluation of Medication Management Service
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.
Read the detailed description
This is a randomized controlled trial which will be conducted across 8 NGO community pharmacies in Hong Kong. The order of providing MMS service by 8 NGO community pharmacies to study participants will be determined by randomization. The time before each NGO community pharmacy provides MMS service to the study participants is considered as the control period (no MMS service will be provided). A total of 8 NGO community pharmacies will be divided into 4 groups and hence 2 pharmacies will have the same length of control period. The control periods will be categorized into 3-month, 6-month, 9-month and 12-month long. It is anticipated that a total of 640 participants will be recruited to the trial. Informed written consent will be obtained from the study participants before the study starts. Since this trial will involve accessing to personal and healthcare information of study participants for analysis, informed written consent will also be sought for the authorization to access clinical data on the Electronic Health Record Sharing System (eHealth) and the electronic health records from the Hospital Authority (HA) for service evaluation and research purposes. Eligible participants will receive MMS service provided by the pharmacists who work in the NGO community pharmacies after the control period. Different study instruments and methods will be used to evaluate humanistic, clinical and economic outcomes.
To evaluate the humanistic outcomes, participants will complete the validated questionnaires at 5 different 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. Descriptive statistics will be conducted to summarize the participants' characteristics and outcomes of interest. Linear and nonlinear mixed effect models will be conducted for continuous and binary outcomes, respectively.
To evaluate the clinical outcomes, electronic health records of the trial participants will be extracted from the electronic health database of the HA. The HA is the statutory organization that coordinates all public hospitals and primary care clinics, and is responsible for managing the majority of patients with chronic diseases in Hong Kong. Participants' demographics, medical records and clinical parameters will be collected from the HA clinical management system database. Clinical parameters such as blood pressure and blood glucose level will be used to evaluate the differences between before and after MMS. In addition, the attendance and admission records of A\&E and hospitalization will also be collected to evaluate the changes in the health service utilization before and after MMS.
For the evaluation of economic outcomes, a costing study will be conducted to collect the set-up costs and operation costs of MMS service via sending questionnaires to the 8 NGO community pharmacies. Participants will complete the validated questionnaire on health-related quality of life (EQ-5D) to estimate quality-adjusted life years (QALYs). The differences in health service utilization, medical costs and QALYs in participants before and after using MMS will be estimated. The Incremental cost-effectiveness ratio (ICER) based on incremental cost per additional QALY would be calculated. Probabilistic sensitivity analysis based on Monte Carlo simulation will be conducted to test the robustness of estimated costs and QALYs. Finally, a cost-effectiveness acceptability curve will be constructed to assess the simulated probability over a range of amounts that a decision-maker might be willing to pay the MMS for an additional QALY.
- Conditions
- Medication Adherence, Medication Safety, Diabetes Mellitus, Type 2, Hypertension, Polypharmacy, High Risk Medications
- Being tested
- Medication Management Service (MMS)
- Keywords
- Medication Management Service, Community pharmacy service
- Medical subject headings
- Medication Adherence, Diabetes Mellitus, Type 2, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication Management Service (MMS)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Changes in health service utilization (e.g. A\&E admission, hospitalization) before and after receiving medication management service will be assessed using record linkage to the electronic health records from the Hospital Authority.
Measured: Through study completion, an average of 1 year
Patient perception and satisfaction
Patient perception and satisfaction will be assessed by the Pharmacy Services Questionnaire (PSQ). The PSQ consists of 20 items and will be rated by participants on a 5-point scale. (5-Excellent, 4- Very good, 3-Good, 2-Fair and 1-Poor). The maximum score is 100 and the minimum score is 20. Higher scores indicate high levels of satisfaction.
Measured: 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
Perceived Sensitivity to Medicines Scale (PSM-5) will be used to assess the patient's perception on their sensitivity to medicines. Patients will rate the items on a 5-point scale. (5-Strongly agree, 4- Agree, 3-Neutral, 2-Disagree and 1-Strongly disagree).The maximum score is 25 and the minimum score is 5. Higher scores indicate stronger perceived sensitivity to medicines.
Measured: 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 by the Patient Enablement Index (PEI). The PEI is a 6-item questionnaire and is used to assess patient enablement. The maximum score of PEI is 12 and minimum score is 0. Higher scores indicate greater levels of enablement and a score of 0 indicates no enablement.
Measured: 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 by the EuroQol EQ-5D-5L (EQ-5D-5L). The EQ-5D-5L is a 5-item questionnaire used to assess health-related quality of life. The maximum score of EQ-5D-5L is 25 and the minimum score is 5. Higher scores indicate better health status. EQ-5D visual analog scale records the respondent's self-rated health status on a graduated (0-100) scale, with higher scores for higher health related quality of life.
Measured: 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.
Drug-related problems
The number of drug-related problems will be extracted from the computerized clinical documentations system input by the pharmacists.
Measured: Throughout the study period, up to 24 months.
Change in costs
A costing questionnaire will be used for extracting set-up and operational costs of delivering Medication Management Services. Change in health service utilization rate will be obtained from the electronic health records managed by Hospital Authority (HA). Cost associated with the health service utilization will be obtained from the HA Gazette. Change in costs is defined by the difference between before and after MMS intervention.
Measured: Throughout the study period, up to 24 months.
Change in effectiveness
Effectiveness will be measured by quality adjusted life years (QALYs), which will be derived from the EQ-5D-5L adjustment weights. Change in effectiveness is defined by the difference between before and after MMS intervention.
Measured: Throughout the study period, up to 24 months.
Incremental cost effectiveness ratio (ICER)
Incremental cost effectiveness ratio (ICER) is defined as changes in cost divided by changes in QALYs.
Measured: Throughout the study period, up to 24 months.
Beliefs in medicines
The Beliefs about Medicines Questionnaire (BMQ) is a 23-item questionnaire used to assess medication beliefs and perceptions toward medications. The BMQ consists of BMQ-General and BMQ-Specific. BMQ-General is used to assess beliefs that medicines are overused (General-Overuse), medicines are harmful (General-Harm) and medicines are beneficial (General-Benefit). BMQ-Specific assesses beliefs about the necessity of medicines to maintain health (Specific-Necessity) and concerns about potential adverse effects of medicines (Specific-Concerns). Items are scored on a 5-point Likert scale. The score range for BMQ is 23-115. Higher scores indicate stronger beliefs in the subscale.
Measured: Beliefs in medicines 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start6 Feb 2024
- Primary completion1 Aug 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The Hong Kong Jockey Club Charities Trust, Hong Kong Sheng Kung Hui Welfare Council Limited, Hong Kong Young Women's Christian Association, Haven of Hope Hospital, Pok Oi Hospital, St. James' Settlement, Aberdeen Kai-fong Welfare Association, Health In Action, Lok Sin Tong Benevolent Society, Kowloon
- Responsible party
- Principal investigator, Prof. Ian Chi Kei Wong, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273761
- Sponsor's protocol ID
- UW 23-550
- Status last verified
- Jan 2024
- First submitted
- 9 Jan 2024
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Care Community Pharmacy Project: Evaluation of Medication Management Service
- ClinicalTrials.gov ID
- NCT06273761
- Acronym / sponsor ID
- UW 23-550
- Conditions
- Medication Adherence, Medication Safety, Diabetes Mellitus, Type 2, Hypertension, Polypharmacy, High Risk Medications
- Keywords
- Medication Management Service, Community pharmacy service
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- The Hong Kong Jockey Club Charities Trust, Hong Kong Sheng Kung Hui Welfare Council Limited, Hong Kong Young Women's Christian Association, Haven of Hope Hospital, Pok Oi Hospital, St. James' Settlement, Aberdeen Kai-fong Welfare Association, Health In Action, Lok Sin Tong Benevolent Society, Kowloon
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a randomized controlled trial which will be conducted across 8 NGO community pharmacies in Hong Kong. The order of providing MMS service by 8 NGO community pharmacies to study participants will be determined by randomization. The time before each NGO community pharmacy provides MMS service to the study participants is considered as the control period (no MMS service will be provided). A total of 8 NGO community pharmacies will be divided into 4 groups and hence 2 pharmacies will have the same length of control period. The control periods will be categorized into 3-month, 6-month, 9-month and 12-month long. It is anticipated that a total of 640 participants will be recruited to the trial. Informed written consent will be obtained from the study participants before the study starts. Since this trial will involve accessing to personal and healthcare information of study participants for analysis, informed written consent will also be sought for the authorization to access clinical data on the Electronic Health Record Sharing System (eHealth) and the electronic health records from the Hospital Authority (HA) for service evaluation and research purposes. Eligible participants will receive MMS service provided by the pharmacists who work in the NGO community pharmacies after the control period. Different study instruments and methods will be used to evaluate humanistic, clinical and economic outcomes.
To evaluate the humanistic outcomes, participants will complete the validated questionnaires at 5 different 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. Descriptive statistics will be conducted to summarize the participants' characteristics and outcomes of interest. Linear and nonlinear mixed effect models will be conducted for continuous and binary outcomes, respectively.
To evaluate the clinical outcomes, electronic health records of the trial participants will be extracted from the electronic health database of the HA. The HA is the statutory organization that coordinates all public hospitals and primary care clinics, and is responsible for managing the majority of patients with chronic diseases in Hong Kong. Participants' demographics, medical records and clinical parameters will be collected from the HA clinical management system database. Clinical parameters such as blood pressure and blood glucose level will be used to evaluate the differences between before and after MMS. In addition, the attendance and admission records of A\&E and hospitalization will also be collected to evaluate the changes in the health service utilization before and after MMS.
For the evaluation of economic outcomes, a costing study will be conducted to collect the set-up costs and operation costs of MMS service via sending questionnaires to the 8 NGO community pharmacies. Participants will complete the validated questionnaire on health-related quality of life (EQ-5D) to estimate quality-adjusted life years (QALYs). The differences in health service utilization, medical costs and QALYs in participants before and after using MMS will be estimated. The Incremental cost-effectiveness ratio (ICER) based on incremental cost per additional QALY would be calculated. Probabilistic sensitivity analysis based on Monte Carlo simulation will be conducted to test the robustness of estimated costs and QALYs. Finally, a cost-effectiveness acceptability curve will be constructed to assess the simulated probability over a range of amounts that a decision-maker might be willing to pay the MMS for an additional QALY.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Medication Management Service (MMS)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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- aged below 18
- unable to give informed consent
- unable to communicate in Cantonese and/or English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medication Management Service (MMS)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. | Behavioural | Intervention |
Primary outcome
Medication adherence
Time frame: 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.
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.
10 secondary outcomes
Additional health service utilization
Time frame: Through study completion, an average of 1 year
Patient perception and satisfaction
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Drug-related problems
Time frame: Throughout the study period, up to 24 months.
Change in costs
Time frame: Throughout the study period, up to 24 months.
Change in effectiveness
Time frame: Throughout the study period, up to 24 months.
Incremental cost effectiveness ratio (ICER)
Time frame: Throughout the study period, up to 24 months.
Beliefs in medicines
Time frame: Beliefs in medicines 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication Management Service (MMS) in people with Medication Adherence and Medication Safety, run by The University of Hong Kong at 8 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ian Chi Kei Wong, PhD (+852 3917 9441, wongick@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.