Impact of Bilingual Prescription Medication Labels Among Elderly Singaporeans

Singapore Health Services (SingHealth)

Status: Withdrawn

Conditions: Hypertension; Diabetes Mellitus, Type 2

Treatments: Device: Bilingual prescription medication labels

Study type: Interventional

Funder types: Other

Identifiers

NCT05101330

1

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 50+ years old

Volunteers: No 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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 4 patient groups

Pilot Trial A, Usual Care arm

No Intervention group

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.

Pilot Trial A, Intervention arm

Experimental group

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.

Treatment:

Device: Bilingual prescription medication labels

Pilot Trial B, Usual Care arm

No Intervention group

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.

Pilot Trial B, Intervention arm

Experimental group

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.

Treatment:

Device: Bilingual prescription medication labels