Impact of Bilingual Prescription Medication Labels Among Elderly Singaporeans

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of Bilingual Prescription Medication Labels on Medication Adherence and Medication Management Self-Efficacy Among Elderly Singaporeans: A Pilot Study

Conditions
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Diabetes Mellitus, Type 2, Hypertension

Intervention / Treatment
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* Device: Bilingual prescription medication labels


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Pilot Trial A, Usual Care arm<br>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. | |
| Experimental: Pilot Trial A, Intervention arm<br>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. | Device: Bilingual prescription medication labels<br>* The bilingual PML contains English and Chinese medication-related instructions for participants.<br>* Other names: PMLs;|
| No Intervention: Pilot Trial B, Usual Care arm<br>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. | |
| Experimental: Pilot Trial B, Intervention arm<br>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. | Device: Bilingual prescription medication labels<br>* The bilingual PML contains English and Chinese medication-related instructions for participants.<br>* Other names: PMLs;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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)) | 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)) | 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. | 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. | 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). | 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). | 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. | 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. | Week 2 of Pilot Trial B | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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