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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
The bilingual PML contains English and Chinese medication-related instructions for participants.
Singapore General Hospital
Singapore, Singapore
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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))
Time frame: 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))
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Week 2 of Pilot Trial B