Impact of Bilingual Prescription Medication Labels Among Elderly Singaporeans

NCT05101330 | Withdrawn DMC

• 1 other identifier: 1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (12)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (4)

Pilot Trial A, Usual Care arm

NO INTERVENTION

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

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

Pilot Trial B, Usual Care arm

NO INTERVENTION

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

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

Interventions

Bilingual prescription medication labels DEVICE

The bilingual PML contains English and Chinese medication-related instructions for participants.

Also known as: PMLs

Pilot Trial A, Intervention arm; Pilot Trial B, Intervention arm

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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)

Sponsors & Collaborators

• Singapore General Hospital: lead
• Duke-NUS Graduate Medical School: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

Location

Related Publications (2)

• 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.

  PMID: 30517628 BACKGROUND

• 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.

  PMID: 29190378 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension; Medication Adherence; Literacy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Communication

Study Officials

• Giat Yeng Khee, PhD

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: November 1, 2021
• Study Start: November 1, 2021
• Primary Completion: May 12, 2022
• Study Completion: May 12, 2022
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)