Coronary DiseaseNCT04004546
Improving Medication Adherence Through a Health Literacy-based Intervention for Coronary Heart Disease Patients
A study testing Health literacy-based intervention in people with Coronary Disease, run by Chinese University of Hong Kong at 2 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease
- What is being tested?
- Health literacy-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 18 Mar 2019to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Hong Kong1 site, 1 recruiting
- Recruiting
The Nethersole School of Nursing, The Chinese University of Hong Kong
Shatin, New Territories
Elaine Siow, PhD, (+852) 39439303, elainesiow@cuhk.edu.hk
Taiwan1 site, 1 recruiting
- Not yet recruiting
School of Nursing, National Taiwan University
Taipei
Nien-Tzu Chang, PhD, (+886) 2 23123456 ext. 88433, ntchang@ntu.edu.tw
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Disease
- Being tested
- Health literacy-based intervention
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health literacy-based interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | At baseline: video and education booklet. 2-weeks after enrollment: telephone call by nurse. Receives: Behavioral: Health literacy-based intervention |
| Control group | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 4-weeks follow-up
Secondary outcomes (1)
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.
Measured: Baseline and 4-weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start18 Mar 2019
- Primary completion30 Sep 2019 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University
- Responsible party
- Principal investigator, Elaine Siow, Chinese University of Hong Kong
- Investigators
- Elaine Siow, PhD, Principal investigator, Chinese University of Hong KongChang Nien-Tzu, PhD, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04004546
- Sponsor's protocol ID
- 4750368
- Status last verified
- Jun 2019
- First submitted
- 27 Jun 2019
- Last updated
- 2 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Medication Adherence Through a Health Literacy-based Intervention for Coronary Heart Disease Patients With Low Health Literacy
- ClinicalTrials.gov ID
- NCT04004546
- Acronym / sponsor ID
- 4750368
- Conditions
- Coronary Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- National Taiwan University
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 2 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Health literacy-based interventionAt baseline: video and education booklet. 2-weeks after enrollment: telephone call by nurse. |
| Control group | No intervention | –Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health literacy-based interventionParticipants 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. | Behavioural | Intervention group |
Primary outcome
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.
1 secondary outcome
Change from baseline medication self-efficacy at 4-weeks follow-up
Time frame: Baseline and 4-weeks follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Coronary Disease
Recruiting
Systematic Ambulatory ECG Monitoring Following TAVI
Aortic Stenosis, Conduction Disturbances
Recruiting
Postural Mobilization Compared to Noradrenaline Only in Off-Pump CABG Surgery
Coronary Artery Disease With Need for Bypass Surgery, Coronary Artery Disease(CAD)
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
Active, not recruiting
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
Atrial Fibrillation
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elaine Siow, PhD principal investigator
Chinese University of Hong Kong
Chang Nien-Tzu, PhD principal investigator
National Taiwan University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health literacy-based intervention in people with Coronary Disease, run by Chinese University of Hong Kong at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elaine Siow, PhD ((+852) 39439303, elainesiow@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline medication adherence at 4-weeks follow-up (time frame: Baseline and 4-weeks follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2019.