Clinical trial NCT05101330: 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
Overall status: WITHDRAWN
Phase: NA
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
Anti-hypertensives
Glucose-lowering agent
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
Collaborators: name: Duke-NUS Graduate Medical School
First posted: 2021-11-01
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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)

Primary outcomes:
measure: Measuring change from Week 2 in Medication Adherence on the Adherence to Refills and Medications Scale (ARMS) at Week 4. (Pilot Trial A)
timeFrame: Week 2 and Week 4 of Pilot Trial A
measure: Assessing Medication Adherence on the ARMS at Week 2. (Pilot Trial B)
timeFrame: Week 2 of Pilot Trial B
measure: Measuring change from Week 2 in Medication Adherence using the MedTake Assessment at Week 4. (Pilot Trial A)
timeFrame: Week 2 and Week 4 of Pilot Trial A
measure: Assessing Medication Adherence using the MedTake Assessment at Week 2 (Pilot Trial B)
timeFrame: Week 2 of Pilot Trial B
measure: Measuring change from Week 2 in Medication Adherence via Pill Count at Week 4. (Pilot Trial A)
timeFrame: Week 2 and Week 4 of Pilot Trial A
measure: Assessing Medication Adherence via Pill Count at Week 2. (Pilot Trial B)
timeFrame: Week 2 of Pilot Trial B
measure: Measuring change from Week 2 in Medication Adherence based on Rx Cap openings at Week 4. (Pilot Trial A)
timeFrame: Week 2 and Week 4 of Pilot Trial A
measure: Assessing Medication Adherence based on Rx Cap openings at Week 2. (Pilot Trial B)
timeFrame: Week 2 of Pilot Trial B
measure: Measuring change from Week 2 in Medication management self-efficacy on the MUSE Scale at Week 4. (Pilot Trial A)
timeFrame: Week 2 and Week 4 of Pilot Trial A
measure: Measuring Medication management self-efficacy on the MUSE Scale at Week 2 (Pilot Trial B)
timeFrame: Week 2 of Pilot Trial B
measure: Measuring change from Week 2 in PML understanding at Week 4. (Pilot Trial A)
timeFrame: Week 2 and Week 4 of Pilot Trial A
measure: Assessing PML understanding at Week 2. (Pilot Trial B)
timeFrame: Week 2 of Pilot Trial B
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Giat Yeng Khee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.