Diabetes Mellitus, Type 2, Hypertension
Conditions
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
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.
Interventions
DEVICEBilingual prescription medication labels
The bilingual PML contains English and Chinese medication-related instructions for participants.
Sponsors
Duke-NUS Graduate Medical School
Singapore General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measuring change from Week 2 in Medication Adherence on the Adherence to Refills and Medications Scale (ARMS) at Week 4. (Pilot Trial A) | 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. |
| Assessing Medication Adherence on the ARMS at Week 2. (Pilot Trial B) | 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. |
| Measuring change from Week 2 in Medication Adherence using the MedTake Assessment at Week 4. (Pilot Trial A) | 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. |
| Assessing Medication Adherence using the MedTake Assessment at Week 2 (Pilot Trial B) | 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. |
| Measuring change from Week 2 in Medication Adherence via Pill Count at Week 4. (Pilot Trial A) | 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)) |
| Assessing Medication Adherence via Pill Count at Week 2. (Pilot Trial B) | 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)) |
| Measuring change from Week 2 in Medication Adherence based on Rx Cap openings at Week 4. (Pilot Trial A) | 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. |
| Assessing Medication Adherence based on Rx Cap openings at Week 2. (Pilot Trial B) | 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. |
| Measuring change from Week 2 in Medication management self-efficacy on the MUSE Scale at Week 4. (Pilot Trial A) | 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). |
| Measuring Medication management self-efficacy on the MUSE Scale at Week 2 (Pilot Trial B) | 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). |
| Measuring change from Week 2 in PML understanding at Week 4. (Pilot Trial A) | 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. |
| Assessing PML understanding at Week 2. (Pilot Trial B) | 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. |
Countries
Singapore
Outcome results
None listed