Impact of Bilingual Prescription Medication Labels Among Elderly Singaporeans

May 17, 2022 updated by: Singapore General Hospital

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 169608
        • Singapore General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Pilot Trial A, Usual Care arm
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
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
The bilingual PML contains English and Chinese medication-related instructions for participants.
Other Names:
  • PMLs
No Intervention: Pilot Trial B, Usual Care arm
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
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
The bilingual PML contains English and Chinese medication-related instructions for participants.
Other Names:
  • PMLs

What is the study measuring?

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)
Time Frame: Week 2 and Week 4 of 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)
Time Frame: Week 2 of 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)
Time Frame: Week 2 and Week 4 of 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)
Time Frame: Week 2 of 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)
Time Frame: Week 2 and Week 4 of 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)
Time Frame: Week 2 of 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)
Time Frame: Week 2 and Week 4 of 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)
Time Frame: Week 2 of 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)
Time Frame: Week 2 and Week 4 of 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)
Time Frame: Week 2 of 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)
Time Frame: Week 2 and Week 4 of 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)
Time Frame: Week 2 of 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Singapore General Hospital

Collaborators

Duke-NUS Graduate Medical School

Investigators

  • Principal Investigator: Giat Yeng Khee, PhD, Singapore General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2021

Primary Completion (Actual)

May 12, 2022

Study Completion (Anticipated)

May 12, 2022

Study Registration Dates

First Submitted

March 29, 2021

First Submitted That Met QC Criteria

October 19, 2021

First Posted (Actual)

November 1, 2021

Study Record Updates

Last Update Posted (Actual)

May 24, 2022

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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