Improving Medication Adherence Through a Health Literacy-based Intervention for Coronary Heart Disease Patients
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|ClinicalTrials.gov Identifier: NCT04004546|
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : July 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Coronary Disease||Behavioral: Health literacy-based intervention||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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|
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
- 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.
- 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.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04004546
|Contact: Elaine Siow, PhD||(+852) firstname.lastname@example.org|
|The Nethersole School of Nursing, The Chinese University of Hong Kong||Recruiting|
|Sha Tin, New Territories, Hong Kong|
|Contact: Elaine Siow, PhD (+852) 39439303 email@example.com|
|School of Nursing, National Taiwan University||Not yet recruiting|
|Contact: Nien-Tzu Chang, PhD (+886) 2 23123456 ext 88433 firstname.lastname@example.org|
|Principal Investigator:||Elaine Siow, PhD||Chinese University of Hong Kong|
|Principal Investigator:||Chang Nien-Tzu, PhD||National Taiwan University|