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Clinical Trials/NCT04004546
NCT04004546
Unknown
Not Applicable

Improving Medication Adherence Through a Health Literacy-based Intervention for Coronary Heart Disease Patients With Low Health Literacy

Chinese University of Hong Kong2 sites in 2 countries60 target enrollmentMarch 18, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Disease
Sponsor
Chinese University of Hong Kong
Enrollment
60
Locations
2
Primary Endpoint
Change from baseline medication adherence at 4-weeks follow-up
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 18, 2019
End Date
September 30, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elaine Siow

Professional Consultant

Chinese University of Hong Kong

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.

Outcomes

Primary Outcomes

Change from baseline medication adherence at 4-weeks follow-up

Time Frame: 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 Outcomes

  • Change from baseline medication self-efficacy at 4-weeks follow-up(Baseline and 4-weeks follow-up)

Study Sites (2)

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