Diabetes Mellitus, Type 2NCT05101330
Impact of Bilingual Prescription Medication Labels Among Elderly Singaporeans
A study testing Bilingual prescription medication labels in people with Diabetes Mellitus, Type 2 and Hypertension, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
The proposed study aims to provide preliminary data that will enable the conduct of a larger Randomized Controlled Trial (RCT) on the impact of bilingual Prescription Medication Labels (PMLs) on 3 medication-related outcomes - medication adherence, medication management self-efficacy, and PML understanding. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Hypertension
- What is being tested?
- Bilingual prescription medication labels
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Nov 2021to 12 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Singapore citizen/permanent resident
- Aged 50 years and above
- Just received a new (i.e., not received before) oral medication for a chronic disease
- No moderate/severe cognitive impairment (5 or more correct responses on the Abbreviated Mental Test, AMT)
- Not deaf (self-reported)
- No binocular presenting near vision impairment (near visual acuity, with routinely used spectacles/lenses: at least 6/15 (0.40 logMAR) on the Landolt's C chart)
Show all 9Show fewer
- Able to speak at least 1 of the 4 official languages;
- Unable to read in English but able to read another official language (as they will benefit the most from bilingual PMLs)
- Assessed as non-adherent
Who cannot join
- Patients who received, from the prescribing physician, a set of instructions for their new oral medication that does not match standard instructions (as the bilingual instructions for non-standard instructions would not be prepared for beforehand)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Bilingual Prescription Medication Labels on Medication Adherence and Medication Management Self-Efficacy Among Elderly Singaporeans: A Pilot Study
The proposed study aims to provide preliminary data that will enable the conduct of a larger Randomized Controlled Trial (RCT) on the impact of bilingual Prescription Medication Labels (PMLs) on 3 medication-related outcomes - medication adherence, medication management self-efficacy, and PML understanding.
Read the detailed description
The investigators will randomize 40 patients to Pilot Trial A or Pilot Trial B. Those in Pilot Trial A will be further randomized to Bilingual PMLs (intervention arm) or English PMLs (usual care arm) at 2 weeks post-recruitment, after assessing baseline level of the 3 medication-related outcomes; trial outcomes: difference in change, from baseline to 2 weeks post-randomization, in the 3 medication-related outcomes between the 2 arms. Those in Pilot Trial B will be further randomized to Bilingual PMLs or English PMLs immediately post-recruitment; trial outcomes: difference, at 2 weeks post-randomization, in the 3 medication-related outcomes between the 2 arms. This formative study will (1) assess the feasibility of administering the intervention, (2) refine protocols for study participant recruitment, engagement and retention, and (3) gain experience with and refine measurement of the outcomes for evaluating the intervention. The conduct of 2 pilot trials will allow us to choose the optimal trial design and determine variability.
- Conditions
- Diabetes Mellitus, Type 2, Hypertension
- Being tested
- Bilingual prescription medication labels
- Keywords
- Medication adherence, Prescription Medication Labels, Bilingual prescription medication labels, Anti-diabetic drugs, Older adults, Medication management self-efficacy, Health literacy, Literacy, Anti-hypertensives, Glucose-lowering agent
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension, Medication Adherence, Literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilingual prescription medication labelsDevice
Also called PMLs
The bilingual PML contains English and Chinese medication-related instructions for participants.
| Study group | Role | What they receive |
|---|---|---|
| Pilot Trial A, Usual Care arm | No intervention | At recruitment, participants will be dispensed with new medication provided together with PMLs in English. After 2 weeks, data will be collected during a home visit and no changes will be made to the PMLs. After another 2 weeks, data will be collected and Rx Cap pill bottles will be retrieved. |
| Pilot Trial A, Intervention arm | Experimental | At recruitment, participants will be dispensed new medication in Rx Cap pill bottles provided with PMLs in English. After 2 weeks, a home visit will be conducted, where the English PMLs will be switched out with bilingual PMLs. A final home visit will be done after another 2 weeks, and the labels will be switched back to the standard-issue PMLs issued by SGH, and the Rx Cap pill bottles will be retrieved. Receives: Device: Bilingual prescription medication labels |
| Pilot Trial B, Usual Care arm | No intervention | At recruitment, participants will be dispensed new medication in Rx Cap pill bottles provided with PMLs in English. After 2 weeks, data will be collected and Rx Cap bottles will be retrieved. |
| Pilot Trial B, Intervention arm | Experimental | At recruitment, participants will be dispensed new medication in Rx Cap pill bottles, provided with bilingual PMLs. After 2 weeks, data will be collected accordingly during the home visit and Rx Cap bottles will be retrieved. Bilingual labels will be removed and participants will resume usage of standard-issue SGH PMLs. Receives: Device: Bilingual prescription medication labels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring change from Week 2 in Medication Adherence on the Adherence to Refills and Medications Scale (ARMS) at Week 4. (Pilot Trial A)
ARMS is a validated self-reported medication-adherence scale intended for patients with chronic diseases.
Its 12 questions consist of 2 subscales - adherence to refilling prescriptions and adherence with taking medications. Each item is structured using the Likert scale, with the following response options and corresponding scores: "none" (score of 1), "some" (score of 2), "most" (score of 3 ), or "all of the time" (score of 4). The range of possible total scores is 12 to 48. Lower scores indicate better adherence.
Measured: Week 2 and Week 4 of Pilot Trial A
Assessing Medication Adherence on the ARMS at Week 2. (Pilot Trial B)
ARMS is a validated self-reported medication-adherence scale intended for patients with chronic diseases.
Its 12 questions consist of 2 subscales - adherence to refilling prescriptions and adherence with taking medications. Each item is structured using the Likert scale, with the following response options and corresponding scores: "none" (score of 1), "some" (score of 2), "most" (score of 3 ), or "all of the time" (score of 4). The range of possible total scores is 12 to 48. Lower scores indicate better adherence.
Measured: Week 2 of Pilot Trial B
Measuring change from Week 2 in Medication Adherence using the MedTake Assessment at Week 4. (Pilot Trial A)
MedTake Assessment is a self-reported measure for pharmacy staff when providing pharmaceutical care services, assessing patient adherence and knowledge to dose, dosage, indication, food or water co-ingestion, and regimen. A composite score (0-100%); higher ~ better) summarizes patient's ability to take medicine safely.
Measured: Week 2 and Week 4 of Pilot Trial A
Assessing Medication Adherence using the MedTake Assessment at Week 2 (Pilot Trial B)
MedTake Assessment is a self-reported measure for pharmacy staff when providing pharmaceutical care services, assessing patient adherence and knowledge to dose, dosage, indication, food or water co-ingestion, and regimen. A composite score (0-100%); higher ~ better) summarizes patient's ability to take medicine safely.
Measured: Week 2 of Pilot Trial B
Measuring change from Week 2 in Medication Adherence via Pill Count at Week 4. (Pilot Trial A)
A pill count, in context of the new oral medication, will be done. % adherence = ((quantity dispensed)-(quantity remaining))/ ((prescribed number of pills per day) x (no. of days between dispensing date and interview))
Measured: Week 2 and Week 4 of Pilot Trial A
Assessing Medication Adherence via Pill Count at Week 2. (Pilot Trial B)
A pill count, in context of the new oral medication, will be done. % adherence = ((quantity dispensed)-(quantity remaining))/ ((prescribed number of pills per day) x (no. of days between dispensing date and interview))
Measured: Week 2 of Pilot Trial B
Measuring change from Week 2 in Medication Adherence based on Rx Cap openings at Week 4. (Pilot Trial A)
The Rx Cap Bluetooth smart cap automatically tracks medication usage every time it is opened. The data collected and stored within the Smart Cap will be imported at home visits with participants. Continuous (% adherence to prescribed regimen; 0-100%) and categorical variables (not at all; partially; fully) for medication adherence will be derived.
Measured: Week 2 and Week 4 of Pilot Trial A
Assessing Medication Adherence based on Rx Cap openings at Week 2. (Pilot Trial B)
The Rx Cap Bluetooth smart cap automatically tracks medication usage every time it is opened. The data collected and stored within the Smart Cap will be imported at home visits with participants. Continuous (% adherence to prescribed regimen; 0-100%) and categorical variables (not at all; partially; fully) for medication adherence will be derived.
Measured: Week 2 of Pilot Trial B
Measuring change from Week 2 in Medication management self-efficacy on the MUSE Scale at Week 4. (Pilot Trial A)
The 8-item Medication Understanding and Use Self-Efficacy Scale (MUSE), comprises of 2 subscales: (1) taking medication (4 items), and (2) learning about medication (4 items). Item scores (four-point Likert scale; strongly disagree (score 1), to, strongly agree (score=4)) will be summed for subscale (range: 4-16) and total scores (range: 8-32; higher score ~ greater level of medication management self-efficacy).
Measured: Week 2 and Week 4 of Pilot Trial A
Measuring Medication management self-efficacy on the MUSE Scale at Week 2 (Pilot Trial B)
The 8-item Medication Understanding and Use Self-Efficacy Scale (MUSE), comprises of 2 subscales: (1) taking medication (4 items), and (2) learning about medication (4 items). Item scores (four-point Likert scale; strongly disagree (score 1), to, strongly agree (score=4)) will be summed for subscale (range: 4-16) and total scores (range: 8-32; higher score ~ greater level of medication management self-efficacy).
Measured: Week 2 of Pilot Trial B
Measuring change from Week 2 in PML understanding at Week 4. (Pilot Trial A)
Respondents will be asked tailored questions (in their preferred language) specific to the instructions presented on their PML for the new oral medication.
Measured: Week 2 and Week 4 of Pilot Trial A
Assessing PML understanding at Week 2. (Pilot Trial B)
Respondents will be asked tailored questions (in their preferred language) specific to the instructions presented on their PML for the new oral medication.
Measured: Week 2 of Pilot Trial B
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start1 Nov 2021 (estimated)
- Primary completion12 May 2022
- Study completion12 May 2022 (estimated)
Why it stopped: Recruitment was challenging, and no participants were recruited after 6 months despite minimizing these challenges. Therefore the study team has decided not to pursue this study any further.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will recruit 40 patients who have just been given a new oral medication for a chronic disease. They will then be randomized (1:1) to either Pilot Trial A or Pilot Trial B. There will be 2 pilot versions of a 2-arm parallel-group RCT.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Duke-NUS Graduate Medical School
- Responsible party
- Sponsor
- Investigators
- Giat Yeng Khee, PhD, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05101330
- Sponsor's protocol ID
- 1
- Status last verified
- May 2022
- First submitted
- 29 Mar 2021
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Malhotra R, Bautista MAC, Muller AM, Aw S, Koh GCH, Theng YL, Hoskins SJ, Wong CH, Miao C, Lim WS, Malhotra C, Chan A. The Aging of a Young Nation: Population Aging in Singapore. Gerontologist. 2019 May 17;59(3):401-410. doi: 10.1093/geront/gny160.
PubMed 30517628Malhotra R, Bautista MAC, Tan NC, Tang WE, Tay S, Tan ASL, Pouliot A, Saffari SE, Chei CL, Vaillancourt R. Bilingual Text With or Without Pictograms Improves Elderly Singaporeans' Understanding of Prescription Medication Labels. Gerontologist. 2019 Mar 14;59(2):378-390. doi: 10.1093/geront/gnx169.
PubMed 29190378
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Bilingual Prescription Medication Labels on Medication Adherence and Medication Management Self-Efficacy Among Elderly Singaporeans: A Pilot Study
- ClinicalTrials.gov ID
- NCT05101330
- Acronym / sponsor ID
- 1
- Conditions
- Diabetes Mellitus, Type 2, Hypertension
- Keywords
- Medication adherence, Prescription Medication Labels, Bilingual prescription medication labels, Anti-diabetic drugs, Older adults, Medication management self-efficacy, Health literacy, Literacy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment was challenging, and no participants were recruited after 6 months despite minimizing these challenges. Therefore the study team has decided not to pursue this study any further.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- Duke-NUS Graduate Medical School
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 12 May 2022 (actual)
- Study completion
- 12 May 2022 (estimated)
- First posted
- 1 Nov 2021 (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.
The proposed study aims to provide preliminary data that will enable the conduct of a larger Randomized Controlled Trial (RCT) on the impact of bilingual Prescription Medication Labels (PMLs) on 3 medication-related outcomes - medication adherence, medication management self-efficacy, and PML understanding.
Detailed description
The investigators will randomize 40 patients to Pilot Trial A or Pilot Trial B. Those in Pilot Trial A will be further randomized to Bilingual PMLs (intervention arm) or English PMLs (usual care arm) at 2 weeks post-recruitment, after assessing baseline level of the 3 medication-related outcomes; trial outcomes: difference in change, from baseline to 2 weeks post-randomization, in the 3 medication-related outcomes between the 2 arms. Those in Pilot Trial B will be further randomized to Bilingual PMLs or English PMLs immediately post-recruitment; trial outcomes: difference, at 2 weeks post-randomization, in the 3 medication-related outcomes between the 2 arms. This formative study will (1) assess the feasibility of administering the intervention, (2) refine protocols for study participant recruitment, engagement and retention, and (3) gain experience with and refine measurement of the outcomes for evaluating the intervention. The conduct of 2 pilot trials will allow us to choose the optimal trial design and determine variability.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- We will recruit 40 patients who have just been given a new oral medication for a chronic disease. They will then be randomized (1:1) to either Pilot Trial A or Pilot Trial B. There will be 2 pilot versions of a 2-arm parallel-group RCT.
| Arm | Type | Receives |
|---|---|---|
| Pilot Trial A, Usual Care arm | No intervention | –At recruitment, participants will be dispensed with new medication provided together with PMLs in English. After 2 weeks, data will be collected during a home visit and no changes will be made to the PMLs. After another 2 weeks, data will be collected and Rx Cap pill bottles will be retrieved. |
| Pilot Trial A, Intervention arm | Experimental | Device: Bilingual prescription medication labelsAt recruitment, participants will be dispensed new medication in Rx Cap pill bottles provided with PMLs in English. After 2 weeks, a home visit will be conducted, where the English PMLs will be switched out with bilingual PMLs. A final home visit will be done after another 2 weeks, and the labels will be switched back to the standard-issue PMLs issued by SGH, and the Rx Cap pill bottles will be retrieved. |
| Pilot Trial B, Usual Care arm | No intervention | –At recruitment, participants will be dispensed new medication in Rx Cap pill bottles provided with PMLs in English. After 2 weeks, data will be collected and Rx Cap bottles will be retrieved. |
| Pilot Trial B, Intervention arm | Experimental | Device: Bilingual prescription medication labelsAt recruitment, participants will be dispensed new medication in Rx Cap pill bottles, provided with bilingual PMLs. After 2 weeks, data will be collected accordingly during the home visit and Rx Cap bottles will be retrieved. Bilingual labels will be removed and participants will resume usage of standard-issue SGH PMLs. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Singapore citizen/permanent resident
- Aged 50 years and above
- Just received a new (i.e., not received before) oral medication for a chronic disease
- No moderate/severe cognitive impairment (5 or more correct responses on the Abbreviated Mental Test, AMT)
- Not deaf (self-reported)
Key exclusion criteria (1 listed)
- Patients who received, from the prescribing physician, a set of instructions for their new oral medication that does not match standard instructions (as the bilingual instructions for non-standard instructions would not be prepared for beforehand)
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 |
|---|---|---|
| Bilingual prescription medication labelsAlso: PMLsThe bilingual PML contains English and Chinese medication-related instructions for participants. | Device | Pilot Trial A, Intervention arm, Pilot Trial B, Intervention arm |
Primary outcome
Measuring change from Week 2 in Medication Adherence on the Adherence to Refills and Medications Scale (ARMS) at Week 4. (Pilot Trial A)
Time frame: Week 2 and Week 4 of Pilot Trial A
ARMS is a validated self-reported medication-adherence scale intended for patients with chronic diseases. Its 12 questions consist of 2 subscales - adherence to refilling prescriptions and adherence with taking medications. Each item is structured using the Likert scale, with the following response options and corresponding scores: "none" (score of 1), "some" (score of 2), "most" (score of 3 ), or "all of the time" (score of 4). The range of possible total scores is 12 to 48. Lower scores indicate better adherence.
Assessing Medication Adherence on the ARMS at Week 2. (Pilot Trial B)
Time frame: Week 2 of Pilot Trial B
ARMS is a validated self-reported medication-adherence scale intended for patients with chronic diseases. Its 12 questions consist of 2 subscales - adherence to refilling prescriptions and adherence with taking medications. Each item is structured using the Likert scale, with the following response options and corresponding scores: "none" (score of 1), "some" (score of 2), "most" (score of 3 ), or "all of the time" (score of 4). The range of possible total scores is 12 to 48. Lower scores indicate better adherence.
Measuring change from Week 2 in Medication Adherence using the MedTake Assessment at Week 4. (Pilot Trial A)
Time frame: Week 2 and Week 4 of Pilot Trial A
MedTake Assessment is a self-reported measure for pharmacy staff when providing pharmaceutical care services, assessing patient adherence and knowledge to dose, dosage, indication, food or water co-ingestion, and regimen. A composite score (0-100%); higher ~ better) summarizes patient's ability to take medicine safely.
Assessing Medication Adherence using the MedTake Assessment at Week 2 (Pilot Trial B)
Time frame: Week 2 of Pilot Trial B
MedTake Assessment is a self-reported measure for pharmacy staff when providing pharmaceutical care services, assessing patient adherence and knowledge to dose, dosage, indication, food or water co-ingestion, and regimen. A composite score (0-100%); higher ~ better) summarizes patient's ability to take medicine safely.
Measuring change from Week 2 in Medication Adherence via Pill Count at Week 4. (Pilot Trial A)
Time frame: Week 2 and Week 4 of Pilot Trial A
A pill count, in context of the new oral medication, will be done. % adherence = ((quantity dispensed)-(quantity remaining))/ ((prescribed number of pills per day) x (no. of days between dispensing date and interview))
Assessing Medication Adherence via Pill Count at Week 2. (Pilot Trial B)
Time frame: Week 2 of Pilot Trial B
A pill count, in context of the new oral medication, will be done. % adherence = ((quantity dispensed)-(quantity remaining))/ ((prescribed number of pills per day) x (no. of days between dispensing date and interview))
Measuring change from Week 2 in Medication Adherence based on Rx Cap openings at Week 4. (Pilot Trial A)
Time frame: Week 2 and Week 4 of Pilot Trial A
The Rx Cap Bluetooth smart cap automatically tracks medication usage every time it is opened. The data collected and stored within the Smart Cap will be imported at home visits with participants. Continuous (% adherence to prescribed regimen; 0-100%) and categorical variables (not at all; partially; fully) for medication adherence will be derived.
Assessing Medication Adherence based on Rx Cap openings at Week 2. (Pilot Trial B)
Time frame: Week 2 of Pilot Trial B
The Rx Cap Bluetooth smart cap automatically tracks medication usage every time it is opened. The data collected and stored within the Smart Cap will be imported at home visits with participants. Continuous (% adherence to prescribed regimen; 0-100%) and categorical variables (not at all; partially; fully) for medication adherence will be derived.
Measuring change from Week 2 in Medication management self-efficacy on the MUSE Scale at Week 4. (Pilot Trial A)
Time frame: Week 2 and Week 4 of Pilot Trial A
The 8-item Medication Understanding and Use Self-Efficacy Scale (MUSE), comprises of 2 subscales: (1) taking medication (4 items), and (2) learning about medication (4 items). Item scores (four-point Likert scale; strongly disagree (score 1), to, strongly agree (score=4)) will be summed for subscale (range: 4-16) and total scores (range: 8-32; higher score ~ greater level of medication management self-efficacy).
Measuring Medication management self-efficacy on the MUSE Scale at Week 2 (Pilot Trial B)
Time frame: Week 2 of Pilot Trial B
The 8-item Medication Understanding and Use Self-Efficacy Scale (MUSE), comprises of 2 subscales: (1) taking medication (4 items), and (2) learning about medication (4 items). Item scores (four-point Likert scale; strongly disagree (score 1), to, strongly agree (score=4)) will be summed for subscale (range: 4-16) and total scores (range: 8-32; higher score ~ greater level of medication management self-efficacy).
Measuring change from Week 2 in PML understanding at Week 4. (Pilot Trial A)
Time frame: Week 2 and Week 4 of Pilot Trial A
Respondents will be asked tailored questions (in their preferred language) specific to the instructions presented on their PML for the new oral medication.
Assessing PML understanding at Week 2. (Pilot Trial B)
Time frame: Week 2 of Pilot Trial B
Respondents will be asked tailored questions (in their preferred language) specific to the instructions presented on their PML for the new oral medication.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Background: PubMed 30517628Malhotra R, Bautista MAC, Muller AM, Aw S, Koh GCH, Theng YL, Hoskins SJ, Wong CH, Miao C, Lim WS, Malhotra C, Chan A. The Aging of a Young Nation: Population Aging in Singapore. Gerontologist. 2019 May 17;59(3):401-410. doi: 10.1093/geront/gny160.
- Background: PubMed 29190378Malhotra R, Bautista MAC, Tan NC, Tang WE, Tay S, Tan ASL, Pouliot A, Saffari SE, Chei CL, Vaillancourt R. Bilingual Text With or Without Pictograms Improves Elderly Singaporeans' Understanding of Prescription Medication Labels. Gerontologist. 2019 Mar 14;59(2):378-390. doi: 10.1093/geront/gnx169.
- 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. This study is not recruiting at the moment.
Giat Yeng Khee, PhD principal investigator
Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilingual prescription medication labels in people with Diabetes Mellitus, Type 2 and Hypertension, run by Singapore General Hospital at 1 site in Singapore.
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 9 inclusion and 1 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: withdrawn, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring change from Week 2 in Medication Adherence on the Adherence to Refills and Medications Scale (ARMS) at Week 4. (Pilot Trial A) (time frame: Week 2 and Week 4 of Pilot Trial A). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05101330, which also lists 2 linked publications.
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 24 May 2022.