Medication AdherenceNCT02793830
A Mobile Phone Based Medication Reminder Program
A study testing Daily reminders of taking medications and Educational materials in people with Medication Adherence, run by Duke University.
Trial summary
This study evaluates the feasibility and acceptability of using mobile applications to improve medication adherence. Participants in the experimental group will receive educational materials and daily reminders through mobile applications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence
- What is being tested?
- Daily reminders of taking medications and Educational materials
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- 11 Jul 2016to 12 Nov 2016
- 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
- having a medical diagnosis of CHD
- being eighteen years old or older
- having an antihypertensive medication regimen that lasts for forty-nine days or more at the enrollment
- being able to read messages through mobile phone
- having a mobile phone which can receive messages from WeChat, and can receive daily reminders from BB Reminder
- having no obvious cognitive impairment
- patients with comorbidities can be included in the study, but during the study, antihypertensive medications are their only prescribed medications (this will be screened by the cardiologist).
Who cannot join
None listed.
About this study
Official title: A Mobile Phone Based Medication Reminder Program for Patients in China With Coronary Heart Disease: A Pilot Study
This study evaluates the feasibility and acceptability of using mobile applications to improve medication adherence. Participants in the experimental group will receive educational materials and daily reminders through mobile applications. While, participants in the control group will receive only educational materials. After the intervention, interviews will be conducted among participants through phone calls.
Read the detailed description
The purpose of this study is to improve medication adherence for Chinese patients with coronary heart disease (CHD) by using mobile applications. An exploratory randomized controlled trial (RCT, N=49) and interviews (n=15) will be included in this pilot study. The RCT will compare the effects of the medication adherence (MA, n=24) intervention and control condition (n=25) on the MA score (percent of prescribed antihypertensive drugs taken), and health outcomes (SBP and DBP obtained) of patients. The health outcomes will be assessed at enrollment and every three days after the intervention begins for thirty days. Feasibility will be determined by the number of patients enrolled, and retention (percent of patients who complete the study). Acceptability (read daily reminders and educational materials via mobile applications) will be evaluated through focus group interviews. All analyses will be performed using SAS 9.3 (Cary, NC). The potential risks of this study are minimal.
- Conditions
- Medication Adherence
- Being tested
- Daily reminders of taking medications, Educational materials
- Keywords
- medication adherence, mHealth, China, heart disease
- Medical subject headings
- Medication Adherence, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily reminders of taking medicationsOther
Reminders. Participants will receive medication-taking reminders from the researcher. These reminders are sent through the mobile application-BB Reminder on an unencrypted external device (a phone borrowed from Duke University School of Nursing and is used specifically for this study by the researcher). BB Reminder has the function that after inputting a patient's phone number and prescriptions, participants can receive reminders through text messages of the name, dosage, function, and administration route for every dose of his/her medications. The daily reminders will be sent to participants 15 minutes before every dose of their medications.
Educational materialsOther
Educational materials. Participants will receive educational materials from the researcher. These educational materials will be sent through the mobile application-WeChat. The educational materials include short articles (< 500 words) and/or pictures. They will be retrieved from the Chinese Cardiovascular Disease-Prevention Information Website (www.healthyheart-china.com), which is governed by the Chinese Ministry of Health. The validity of information from it is guaranteed. The retrieved educational materials will be screened by the cardiologist, the head nurse, and the researcher, before sending to participants. The educational materials will be sent to participants every other day at any time during 8 am and 10 pm.
| Study group | Role | What they receive |
|---|---|---|
| Mobile App Group | Experimental | Participants in the experimental group will receive daily reminders and educational materials from mobile applications. Receives: Other: Daily reminders of taking medications; Other: Educational materials |
| Control Group | Active comparator | The control group will receive the same educational materials, but no daily reminder. Receives: Other: Educational materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in medication adherence score
Percent of prescribed antihypertensive drugs taken during the past three days.
Measured: baseline, day 3, day 6, day 9, day 12, day 15, day 18, day 21, day 24, day 27, day 30.
Change in systolic blood pressure (SBP)
Measured: baseline, day 3, day 6, day 9, day 12, day 15, day 18, day 21, day 24, day 27, day 30.
Change in diastolic blood pressure (DBP)
Measured: baseline, day 3, day 6, day 9, day 12, day 15, day 18, day 21, day 24, day 27, day 30.
Secondary outcomes (3)
Feasibility as measured by patient enrollment
Feasibility will be determined by the number of patients enrolled, and retention (percent of patients who complete the study).
Measured: approximately seven weeks
Feasibility as measured by patient retention
Feasibility will be determined by retention (percent of patients who complete the study)
Measured: approximately seven weeks
Acceptability as measured by patient interviews
Acceptability (read daily reminders and educational materials via mobile applications) will be evaluated through interviews.
Measured: approximately seven weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study start11 Jul 2016
- Primary completion19 Sep 2016
- Study completion12 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793830
- Sponsor's protocol ID
- Pro00073395
- Status last verified
- Jan 2017
- First submitted
- 3 Jun 2016
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Ni Z, Wu B, Yang Q, Yan LL, Liu C, Shaw RJ. An mHealth Intervention to Improve Medication Adherence and Health Outcomes Among Patients With Coronary Heart Disease: Randomized Controlled Trial. J Med Internet Res. 2022 Mar 9;24(3):e27202. doi: 10.2196/27202.
PubMed 35262490
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile Phone Based Medication Reminder Program for Patients in China With Coronary Heart Disease: A Pilot Study
- ClinicalTrials.gov ID
- NCT02793830
- Acronym / sponsor ID
- Pro00073395
- Conditions
- Medication Adherence
- Keywords
- medication adherence, mHealth, China, heart disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 11 Jul 2016
- Primary completion
- 19 Sep 2016 (actual)
- Study completion
- 12 Nov 2016 (actual)
- First posted
- 8 Jun 2016 (estimated)
- 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 study evaluates the feasibility and acceptability of using mobile applications to improve medication adherence. Participants in the experimental group will receive educational materials and daily reminders through mobile applications. While, participants in the control group will receive only educational materials. After the intervention, interviews will be conducted among participants through phone calls.
Detailed description
The purpose of this study is to improve medication adherence for Chinese patients with coronary heart disease (CHD) by using mobile applications. An exploratory randomized controlled trial (RCT, N=49) and interviews (n=15) will be included in this pilot study. The RCT will compare the effects of the medication adherence (MA, n=24) intervention and control condition (n=25) on the MA score (percent of prescribed antihypertensive drugs taken), and health outcomes (SBP and DBP obtained) of patients. The health outcomes will be assessed at enrollment and every three days after the intervention begins for thirty days. Feasibility will be determined by the number of patients enrolled, and retention (percent of patients who complete the study). Acceptability (read daily reminders and educational materials via mobile applications) will be evaluated through focus group interviews. All analyses will be performed using SAS 9.3 (Cary, NC). The potential risks of this study are minimal.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile App Group | Experimental | Other: Daily reminders of taking medications, Other: Educational materialsParticipants in the experimental group will receive daily reminders and educational materials from mobile applications. |
| Control Group | Active comparator | Other: Educational materialsThe control group will receive the same educational materials, but no daily reminder. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- having a medical diagnosis of CHD
- being eighteen years old or older
- having an antihypertensive medication regimen that lasts for forty-nine days or more at the enrollment
- being able to read messages through mobile phone
- having a mobile phone which can receive messages from WeChat, and can receive daily reminders from BB Reminder
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Daily reminders of taking medicationsReminders. Participants will receive medication-taking reminders from the researcher. These reminders are sent through the mobile application-BB Reminder on an unencrypted external device (a phone borrowed from Duke University School of Nursing and is used specifically for this study by the researcher). BB Reminder has the function that after inputting a patient's phone number and prescriptions, participants can receive reminders through text messages of the name, dosage, function, and administration route for every dose of his/her medications. The daily reminders will be sent to participants 15 minutes before every dose of their medications. | Other | Mobile App Group |
| Educational materialsEducational materials. Participants will receive educational materials from the researcher. These educational materials will be sent through the mobile application-WeChat. The educational materials include short articles (< 500 words) and/or pictures. They will be retrieved from the Chinese Cardiovascular Disease-Prevention Information Website (www.healthyheart-china.com), which is governed by the Chinese Ministry of Health. The validity of information from it is guaranteed. The retrieved educational materials will be screened by the cardiologist, the head nurse, and the researcher, before sending to participants. The educational materials will be sent to participants every other day at any time during 8 am and 10 pm. | Other | Control Group, Mobile App Group |
Primary outcome
Change in medication adherence score
Time frame: baseline, day 3, day 6, day 9, day 12, day 15, day 18, day 21, day 24, day 27, day 30.
Percent of prescribed antihypertensive drugs taken during the past three days.
Change in systolic blood pressure (SBP)
Time frame: baseline, day 3, day 6, day 9, day 12, day 15, day 18, day 21, day 24, day 27, day 30.
Change in diastolic blood pressure (DBP)
Time frame: baseline, day 3, day 6, day 9, day 12, day 15, day 18, day 21, day 24, day 27, day 30.
3 secondary outcomes
Feasibility as measured by patient enrollment
Time frame: approximately seven weeks
Feasibility as measured by patient retention
Time frame: approximately seven weeks
Acceptability as measured by patient interviews
Time frame: approximately seven weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
- Derived from this study: PubMed 35262490Ni Z, Wu B, Yang Q, Yan LL, Liu C, Shaw RJ. An mHealth Intervention to Improve Medication Adherence and Health Outcomes Among Patients With Coronary Heart Disease: Randomized Controlled Trial. J Med Internet Res. 2022 Mar 9;24(3):e27202. doi: 10.2196/27202.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Daily reminders of taking medications and Educational materials in people with Medication Adherence, run by Duke University.
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 7 inclusion and 0 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: finished, as of the sponsor's last update on 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in medication adherence score (time frame: baseline, day 3, day 6, day 9, day 12, day 15, day 18, day 21, day 24, day 27, day 30.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02793830, which also lists 1 linked publication.
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 30 Jan 2017.