Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04004546
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : July 2, 2019
Sponsor:
Collaborator:
National Taiwan University
Information provided by (Responsible Party):
Elaine Siow, Chinese University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Coronary Disease Behavioral: Health literacy-based intervention Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Improving Medication Adherence Through a Health Literacy-based Intervention for Coronary Heart Disease Patients With Low Health Literacy
Actual Study Start Date : March 18, 2019
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

No Intervention: Control group
Usual care



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change from baseline medication self-efficacy at 4-weeks follow-up [ Time Frame: 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 Outcome Measures:
  1. Health literacy [ Time Frame: 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.

  2. Perceived social support [ Time Frame: 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.

  3. CHD knowledge [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04004546


Contacts
Layout table for location contacts
Contact: Elaine Siow, PhD (+852) 39439303 elainesiow@cuhk.edu.hk

Locations
Layout table for location information
Hong Kong
The Nethersole School of Nursing, The Chinese University of Hong Kong Recruiting
Sha Tin, New Territories, Hong Kong
Contact: Elaine Siow, PhD    (+852) 39439303    elainesiow@cuhk.edu.hk   
Taiwan
School of Nursing, National Taiwan University Not yet recruiting
Taipei, Taiwan
Contact: Nien-Tzu Chang, PhD    (+886) 2 23123456 ext 88433    ntchang@ntu.edu.tw   
Sponsors and Collaborators
Chinese University of Hong Kong
National Taiwan University
Investigators
Layout table for investigator information
Principal Investigator: Elaine Siow, PhD Chinese University of Hong Kong
Principal Investigator: Chang Nien-Tzu, PhD National Taiwan University
Layout table for additonal information
Responsible Party: Elaine Siow, Professional Consultant, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT04004546    
Other Study ID Numbers: 4750368
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases