Clinical trial NCT04004546: Improving Medication Adherence Through a Health Literacy-based Intervention for Coronary Heart Disease Patients
Official title: Improving Medication Adherence Through a Health Literacy-based Intervention for Coronary Heart Disease Patients With Low Health Literacy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Disease
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: National Taiwan University
First posted: 2019-07-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline medication adherence at 4-weeks follow-up
timeFrame: Baseline and 4-weeks follow-up
Secondary outcomes:
measure: Change from baseline medication self-efficacy at 4-weeks follow-up
timeFrame: Baseline and 4-weeks follow-up
Other outcomes:
measure: Health literacy
timeFrame: Baseline
measure: Perceived social support
timeFrame: Baseline
measure: CHD knowledge
timeFrame: Baseline
Locations:
city: Sha Tin
country: Hong Kong
facility: The Nethersole School of Nursing, The Chinese University of Hong Kong
state: New Territories
city: Taipei
country: Taiwan
facility: School of Nursing, National Taiwan University
Study officials:
affiliation: Chinese University of Hong Kong
name: Elaine Siow, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan University
name: Chang Nien-Tzu, PhD
role: PRINCIPAL_INVESTIGATOR
References: