Not provided
Not provided
Not provided
Not provided
Not provided
Recruitment was challenging, and no participants were recruited after 6 months despite minimizing these challenges. Therefore the study team has decided not to pursue this study any further.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Duke-NUS Graduate Medical School | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilingual prescription medication labels | Device | The bilingual PML contains English and Chinese medication-related instructions for participants. |
|
| 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) | 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. |
Not provided
Not provided
Inclusion Criteria:
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)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Giat Yeng Khee, PhD | Singapore General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Singapore General Hospital | Singapore | 169608 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30517628 | Background | 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. | |
| 29190378 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 10, 2021 | Sep 27, 2021 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 10, 2021 | Oct 14, 2021 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006973 | Hypertension |
| D055118 | Medication Adherence |
| D000067010 | Literacy |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
|
| 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 |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D003142 | Communication |