Coronary Disease
Conditions
Brief summary
This is a multi-center pilot study to examine the effectiveness of a health literacy-based intervention to improve medication adherence and self-efficacy of medication use among individuals with coronary heart disease (CHD). The specific aims are to: i) develop a health literacy-based intervention to improve medication adherence for CHD individuals with low health literacy and ii) evaluate the effects of a health literacy-based intervention on improving medication adherence and self-efficacy in CHD individuals.
Detailed description
The project will be conducted in 2 phases. Phase 1 is to develop the health literacy-based intervention that consists of a video and an education booklet. Phase 2 is to conduct a pilot study to evaluate the effectiveness of the intervention. A total of 60 participants with low health literacy and diagnosed with CHD will be recruited in two settings. Data will be collected at baseline and 4-weeks after enrollment. The following data will be collected: At baseline: Socio-demographic information (e.g. age, gender, education level, income, past medical history, social support), health literacy (eligibility screening at time of recruitment), CHD knowledge, medication adherence, and medication self-efficacy. 4-weeks after enrollment: medication self-efficacy and medication adherence.
Interventions
BEHAVIORALHealth literacy-based intervention
Participants in the intervention group will receive a: i) 30-min video about medication adherence, ii) medication adherence booklet, and iii) 2-week telephone call by a nurse.
Sponsors
National Taiwan University
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged ≥18 years and diagnosed with CHD. * Currently receiving pharmacological therapy such as statins, anti-platelet and/or blood thinner, beta-blockers, calcium channel blockers, nitroglycerin, and angiotensin- converting enzyme inhibitors (ACE). * Low health literacy score of 9 or less as measured using the short-form Mandarin Health Literacy Scale (s-MHLS).
Exclusion criteria
* History of significant cognitive impairment, psychiatric disorders, and aphasia. * Without access to a telephone or unable to give telephone contact. * Currently enrolled in another program or clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline medication adherence at 4-weeks follow-up | Baseline and 4-weeks follow-up | Measured using the Chinese version of the Hill-Bone Medication Adherence Scale (HB-MAS). The HB-MAS is a self-reported measure of the extent of medication adherence. The HB-MAS consists of 9 questions with each item rated on a 4-point scale (1 = none of the time; 2 = some of the time; 3 = most of the time; and 4 = all of the time). The total score ranges from 9 (minimum) to 36 (maximum), where lower scores indicate higher levels of medication adherence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline medication self-efficacy at 4-weeks follow-up | Baseline and 4-weeks follow-up | Measured using the Chinese version of the Self-Efficacy for Appropriate Medication Use (C-SEAMS). The C-SEAMS is a self-reported measure of the extent of confidence in taking medications. The C-SEAMS consists of 13 questions with each item rated on a 3-point scale (1 = not confident; 2 = somewhat confident; 3 = very confident). The total score ranges from 13 (minimum) to 39 (maximum), where higher scores indicate higher levels of self-efficacy for medication use. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Health literacy | Baseline | Measured using the short-form Mandarin Health Literacy Scale (s-MHLS). The s-MHLS consists of 11 questions to determine an individual's functional health literacy in terms of their ability to read, comprehend, and utilize basic health information in making personal health decisions. The sum of correct responses range from 0 (minimum) to 11 (maximum), where higher scores indicate higher levels of health literacy. Individuals with a total score of 9 or less are considered as having low health literacy. |
| Perceived social support | Baseline | Measured using the Chinese version of the Medical Outcomes Study social support survey (MOS-SSS-C). The MOS-SSS-C consists of 19 items that measure 4 subscales of social support: emotional/informational support, tangible support, affectionate support, and positive social interaction. Participants are required to rate each item on a 5-point scale (1 = none of the time; 2 = a little of the time; 3 = some of the time; 4 = most of the time; 5 = all of the time). The average of the 4 subscale scores will be used to calculate the overall score that ranges from 0 (minimum) to 100 (maximum), where higher scores indicate better perceived social support. |
| CHD knowledge | Baseline | Measured using the modified Chinese version of the knowledge inventory (m-CKI). The m-CKI is used to assess the individual's knowledge about CHD. The m-CKI consists of 32 multiple-choice questions with 5 options for each question. The sum of correct responses range from 0 (minimum) to 32 (maximum), where higher scores indicate better knowledge about CHD. |
Countries
Hong Kong, Taiwan
Contacts
Primary ContactElaine Siow, PhD
Outcome results
None listed