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Impact of Bilingual Prescription Medication Labels Among Elderly Singaporeans

Primary Purpose

Diabetes Mellitus, Type 2, Hypertension

Status
Withdrawn
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Bilingual prescription medication labels
Sponsored by
Singapore General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus, Type 2 focused on measuring 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

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)
  • 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

Exclusion Criteria:

- 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)

Sites / Locations

  • Singapore General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

No Intervention

Experimental

Arm Label

Pilot Trial A, Usual Care arm

Pilot Trial A, Intervention arm

Pilot Trial B, Usual Care arm

Pilot Trial B, Intervention arm

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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))
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))
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.
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.
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).
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).
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 29, 2021
Last Updated
May 17, 2022
Sponsor
Singapore General Hospital
Collaborators
Duke-NUS Graduate Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT05101330
Brief Title
Impact of Bilingual Prescription Medication Labels Among Elderly Singaporeans
Official Title
Impact of Bilingual Prescription Medication Labels on Medication Adherence and Medication Management Self-Efficacy Among Elderly Singaporeans: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Withdrawn
Why 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.
Study Start Date
November 1, 2021 (Anticipated)
Primary Completion Date
May 12, 2022 (Actual)
Study Completion Date
May 12, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital
Collaborators
Duke-NUS Graduate Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, Anti-hypertensives, Glucose-lowering agent

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pilot Trial A, Usual Care arm
Arm Type
No Intervention
Arm Description
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.
Arm Title
Pilot Trial A, Intervention arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Pilot Trial B, Usual Care arm
Arm Type
No Intervention
Arm Description
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.
Arm Title
Pilot Trial B, Intervention arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Bilingual prescription medication labels
Other Intervention Name(s)
PMLs
Intervention Description
The bilingual PML contains English and Chinese medication-related instructions for participants.
Primary Outcome Measure Information:
Title
Measuring change from Week 2 in Medication Adherence on the Adherence to Refills and Medications Scale (ARMS) at Week 4. (Pilot Trial A)
Description
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.
Time Frame
Week 2 and Week 4 of Pilot Trial A
Title
Assessing Medication Adherence on the ARMS at Week 2. (Pilot Trial B)
Description
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.
Time Frame
Week 2 of Pilot Trial B
Title
Measuring change from Week 2 in Medication Adherence using the MedTake Assessment at Week 4. (Pilot Trial A)
Description
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.
Time Frame
Week 2 and Week 4 of Pilot Trial A
Title
Assessing Medication Adherence using the MedTake Assessment at Week 2 (Pilot Trial B)
Description
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.
Time Frame
Week 2 of Pilot Trial B
Title
Measuring change from Week 2 in Medication Adherence via Pill Count at Week 4. (Pilot Trial A)
Description
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))
Time Frame
Week 2 and Week 4 of Pilot Trial A
Title
Assessing Medication Adherence via Pill Count at Week 2. (Pilot Trial B)
Description
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))
Time Frame
Week 2 of Pilot Trial B
Title
Measuring change from Week 2 in Medication Adherence based on Rx Cap openings at Week 4. (Pilot Trial A)
Description
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.
Time Frame
Week 2 and Week 4 of Pilot Trial A
Title
Assessing Medication Adherence based on Rx Cap openings at Week 2. (Pilot Trial B)
Description
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.
Time Frame
Week 2 of Pilot Trial B
Title
Measuring change from Week 2 in Medication management self-efficacy on the MUSE Scale at Week 4. (Pilot Trial A)
Description
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).
Time Frame
Week 2 and Week 4 of Pilot Trial A
Title
Measuring Medication management self-efficacy on the MUSE Scale at Week 2 (Pilot Trial B)
Description
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).
Time Frame
Week 2 of Pilot Trial B
Title
Measuring change from Week 2 in PML understanding at Week 4. (Pilot Trial A)
Description
Respondents will be asked tailored questions (in their preferred language) specific to the instructions presented on their PML for the new oral medication.
Time Frame
Week 2 and Week 4 of Pilot Trial A
Title
Assessing PML understanding at Week 2. (Pilot Trial B)
Description
Respondents will be asked tailored questions (in their preferred language) specific to the instructions presented on their PML for the new oral medication.
Time Frame
Week 2 of Pilot Trial B

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) 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 Exclusion Criteria: - 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giat Yeng Khee, PhD
Organizational Affiliation
Singapore General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30517628
Citation
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.
Results Reference
background
PubMed Identifier
29190378
Citation
Malhotra 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.
Results Reference
background

Learn more about this trial

Impact of Bilingual Prescription Medication Labels Among Elderly Singaporeans

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