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

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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Disease
• Intervention / Treatment: Behavioral: Health literacy-based intervention

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elaine Siow, PhD; Phone Number: (+852) 39439303; Email: elainesiow@cuhk.edu.hk

Study Locations

• Hong Kong
  • New Territories
    • Sha Tin, New Territories, Hong Kong
      • Recruiting
      • The Nethersole School of Nursing, The Chinese University of Hong Kong
      • Contact: Elaine Siow, PhD; Phone Number: (+852) 39439303; Email: elainesiow@cuhk.edu.hk
• Taiwan
  • Taipei, Taiwan
    • Not yet recruiting
    • School of Nursing, National Taiwan University
    • Contact: Nien-Tzu Chang, PhD; Phone Number: 88433 (+886) 2 23123456; Email: ntchang@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control group; Usual care
EXPERIMENTAL: Intervention group; At baseline: video and education booklet. 2-weeks after enrollment: telephone call by nurse.	Behavioral: Health 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline medication adherence at 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.	Baseline and 4-weeks follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline medication self-efficacy at 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.	Baseline and 4-weeks follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health literacy	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.	Baseline
Perceived social support	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.	Baseline
CHD knowledge	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.	Baseline

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Collaborators: National Taiwan University
• Investigators: Principal Investigator: Elaine Siow, PhD, Chinese University of Hong Kong; Principal Investigator: Chang Nien-Tzu, PhD, National Taiwan University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 18, 2019
• Primary Completion (ANTICIPATED): September 30, 2019
• Study Completion (ANTICIPATED): September 30, 2019

Study Registration Dates

• First Submitted: June 27, 2019
• First Submitted That Met QC Criteria: June 29, 2019
• First Posted (ACTUAL): July 2, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 2, 2019
• Last Update Submitted That Met QC Criteria: June 29, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 4750368

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No