Impact of Bilingual Prescription Medication Labels Among Elderly Singaporeans

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05101330
• Other study ID #: 1
• Status: Withdrawn
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: May 12, 2022

Study information

• Verified date: May 2022
• Source: Singapore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 12, 2022
• Est. primary completion date: May 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Hypertension

Intervention

Device:
• Bilingual prescription medication labels
The bilingual PML contains English and Chinese medication-related instructions for participants.

Locations

Country	Name	City	State
Singapore	Singapore General Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Singapore General Hospital	Duke-NUS Graduate Medical School

Country where clinical trial is conducted

Singapore, 

References & Publications (2)

Malhotra R, Bautista MAC, Müller 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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