Improving Medication Adherence Through a Health Literacy-based Intervention for Coronary Heart Disease Patients
Primary Purpose
Coronary Disease
Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Health literacy-based intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Coronary Disease
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.
Sites / Locations
- The Nethersole School of Nursing, The Chinese University of Hong KongRecruiting
- School of Nursing, National Taiwan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
At baseline: video and education booklet. 2-weeks after enrollment: telephone call by nurse.
Usual care
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04004546
First Posted
June 27, 2019
Last Updated
June 29, 2019
Sponsor
Chinese University of Hong Kong
Collaborators
National Taiwan University
1. Study Identification
Unique Protocol Identification Number
NCT04004546
Brief Title
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
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 18, 2019 (Actual)
Primary Completion Date
September 30, 2019 (Anticipated)
Study Completion Date
September 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
Collaborators
National Taiwan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
At baseline: video and education booklet. 2-weeks after enrollment: telephone call by nurse.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
Health literacy-based intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline medication adherence at 4-weeks follow-up
Description
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.
Time Frame
Baseline and 4-weeks follow-up
Secondary Outcome Measure Information:
Title
Change from baseline medication self-efficacy at 4-weeks follow-up
Description
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.
Time Frame
Baseline and 4-weeks follow-up
Other Pre-specified Outcome Measures:
Title
Health literacy
Description
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.
Time Frame
Baseline
Title
Perceived social support
Description
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.
Time Frame
Baseline
Title
CHD knowledge
Description
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.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elaine Siow, PhD
Phone
(+852) 39439303
Email
elainesiow@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elaine Siow, PhD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chang Nien-Tzu, PhD
Organizational Affiliation
National Taiwan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Nethersole School of Nursing, The Chinese University of Hong Kong
City
Sha Tin
State/Province
New Territories
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elaine Siow, PhD
Phone
(+852) 39439303
Email
elainesiow@cuhk.edu.hk
Facility Name
School of Nursing, National Taiwan University
City
Taipei
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nien-Tzu Chang, PhD
Phone
(+886) 2 23123456
Ext
88433
Email
ntchang@ntu.edu.tw
12. IPD Sharing Statement
Plan to Share IPD
No
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Improving Medication Adherence Through a Health Literacy-based Intervention for Coronary Heart Disease Patients
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