Hypertension,EssentialNCT04565548
Hypertension Treatment Adherence Improving Trial
A study testing Educational program for hypertensive patients in people with Hypertension,Essential, run by The Hong Kong Polytechnic University at 2 sites in 2 countries.
Trial summary
Persistent adherence to lifestyle modifications and blood pressure lowering medications were the best way to control blood pressure. But low adherence was noted in reviews and studies resulting those taking blood pressure lowering medications could not achieve a controlled blood pressure. Read more about this study
- Who is it for?
- Ages 45 to 74 years
- Conditions the study is for
- Hypertension,Essential
- What is being tested?
- Educational program for hypertensive patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 6 Mar 2021to Sep 2021
- 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 45 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Own a mobile phone and able to use
- Able to communicate with Cantonese and read Chinese
- Diagnosed with hypertension and taking at least one anti-hypertensive medication
- SBP = 131~159 mmHg or DBP = 81~99 mmHg
Who cannot join
- Renal hypertension
- Mini-Cog < 3
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
China1 site, 1 recruiting
- Not yet recruiting
Community Health Centres
Shenzhen, Shenzhen, 00
Qun Wang, PhD, 53431457, wangqunxing0204@163.com
Hong Kong1 site, 1 recruiting
- Recruiting
Complexo de Apoio à Família e de Serviço Comunitário de Seac Pai Van da União Geral das Associações dos Moradores de Macau
Kowloon
Raven Lee
About this study
Official title: Effect of an Educational Program for Hypertensive Patients: a Randomized Controlled Trial
Persistent adherence to lifestyle modifications and blood pressure lowering medications were the best way to control blood pressure. But low adherence was noted in reviews and studies resulting those taking blood pressure lowering medications could not achieve a controlled blood pressure. In this study, a theory-guided educational program will be developed with an aim to improve the blood pressure, self-efficacy and adherence behaviors among those diagnosed with high blood pressure in the community. 148 participants will be recruited and divided into control group and intervention group randomly in a ratio of 1:1. The intervention group will receive the theory-guided educational program, while the control group will receive the usual care. The study will last for 12 weeks. Data will be collected at baseline, week 8 and week 12. SPSS and generalized estimating equations model will be employed for data analysis. The results will inform an effective way to conduct health promotion in community. The improved adherence to lifestyle modifications and medications will be beneficial to the clients' health.
Read the detailed description
Persistent adherence to lifestyle modifications and anti-hypertensive medications were emphasized in hypertension guidelines to control blood pressure effectively. But low adherence to lifestyle modifications and medication were noted in reviews and studies. Low adherence would lead to those received hypertension treatment did not achieve a controlled blood pressure. In this study, an educational program guided by the Health Promotion Model will be conducted to examine the effect on blood pressure, self-efficacy and treatment adherence among hypertensive patients in the community. A 2-arm parallel randomized control trial will be conducted. 148 participants will be recruited and divided into control and intervention group in a ration of 1:1. The intervention group will receive the theory-guided educational program, while the control group will receive the usual care. The study will last for 12 weeks. Data will be collected at baseline, week 8 and week 12. SPSS and generalized estimating equations model will be employed for data analysis. The results will inform community healthcare professionals about the effective way for health promotion, to enhance the adherence to lifestyle modifications and medications among hypertensive clients resulting sustainable benefits to the clients' health.
- Conditions
- Hypertension,Essential
- Being tested
- Educational program for hypertensive patients, Usual care
- Keywords
- hypertension, adherence, self-efficacy, educational intervention
- Medical subject headings
- Essential Hypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational program for hypertensive patientsOther
The theory-guided program consisted of one session of health education, self-developed leaflet, and weekly text messaging for 12 weeks.
Usual careOther
One standardized health education and a leaflet developed by the Health Bureau. As similar as the intervention group, weekly text messaging will be delivered, but the content is not related to the blood pressure control.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will receive the newly developed theory-guided program for 12 weeks. Receives: Other: Educational program for hypertensive patients |
| Control | Active comparator | Participants will receive the usual care and non-hypertension related text messaging for 12 weeks. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of blood pressure at week 8 and week 12
Systolic and diastolic blood pressure (mmHg) is measured by a trained research assistant. A validated upper-arm blood pressure monitor is used for the blood pressure measurement.
Measured: Baseline, week 8, week 12
Secondary outcomes (2)
Change of Treatment Adherence Questionnaire for Patients with Hypertension (TAQPH) at week 8 and week 12
TAQPH consists of 28 items and covers the adherence to medications and lifestyle modifications in hypertension management. The responses are made on a 1-4 scale, and the sum of the score ranges from 28 to 112. The TAQPH has been proved to be reliable with good Cronbach's alpha coefficient 0.86 for Chinese hypertensive adults.
Measured: Baseline, week 8, week 12
Change of Self-efficacy for managing chronic disease (SEMCD) at week 8 and week 12
SEMCD consists of six self-report items to measure the self-efficacy of hypertension management. Summative scores range from 6 to 60. The scale was translated into Chinese and yielded a good reliability (Cronbach's alpha = 0.88-0.98; teste-retest reliability = 0.73-0.98) in Chinese hypertensive adults and Chinese older adults.
Measured: Baseline, week 8, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start6 Mar 2021
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
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 Hypertension,EssentialStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eliza Mi Ling Wong, Dr, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04565548
- Sponsor's protocol ID
- HSEARS20200821002
- Status last verified
- Sep 2020
- First submitted
- 10 Sep 2020
- Last updated
- 4 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tam HL, Wong EML, Cheung K. Educational Program with Text Messaging for Community-Dwelling Patients with Hypertension: A Pilot Randomized Controlled Trial. Asian Nurs Res (Korean Soc Nurs Sci). 2023 Aug;17(3):158-166. doi: 10.1016/j.anr.2023.06.001. Epub 2023 Jun 7.
PubMed 37295501
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Educational Program for Hypertensive Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04565548
- Acronym / sponsor ID
- HSEARS20200821002
- Conditions
- Hypertension,Essential
- Keywords
- hypertension, adherence, self-efficacy, educational intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 6 Mar 2021 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 25 Sep 2020 (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.
Persistent adherence to lifestyle modifications and blood pressure lowering medications were the best way to control blood pressure. But low adherence was noted in reviews and studies resulting those taking blood pressure lowering medications could not achieve a controlled blood pressure. In this study, a theory-guided educational program will be developed with an aim to improve the blood pressure, self-efficacy and adherence behaviors among those diagnosed with high blood pressure in the community. 148 participants will be recruited and divided into control group and intervention group randomly in a ratio of 1:1. The intervention group will receive the theory-guided educational program, while the control group will receive the usual care. The study will last for 12 weeks. Data will be collected at baseline, week 8 and week 12. SPSS and generalized estimating equations model will be employed for data analysis. The results will inform an effective way to conduct health promotion in community. The improved adherence to lifestyle modifications and medications will be beneficial to the clients' health.
Detailed description
Persistent adherence to lifestyle modifications and anti-hypertensive medications were emphasized in hypertension guidelines to control blood pressure effectively. But low adherence to lifestyle modifications and medication were noted in reviews and studies. Low adherence would lead to those received hypertension treatment did not achieve a controlled blood pressure. In this study, an educational program guided by the Health Promotion Model will be conducted to examine the effect on blood pressure, self-efficacy and treatment adherence among hypertensive patients in the community. A 2-arm parallel randomized control trial will be conducted. 148 participants will be recruited and divided into control and intervention group in a ration of 1:1. The intervention group will receive the theory-guided educational program, while the control group will receive the usual care. The study will last for 12 weeks. Data will be collected at baseline, week 8 and week 12. SPSS and generalized estimating equations model will be employed for data analysis. The results will inform community healthcare professionals about the effective way for health promotion, to enhance the adherence to lifestyle modifications and medications among hypertensive clients resulting sustainable benefits to the clients' health.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Educational program for hypertensive patientsParticipants will receive the newly developed theory-guided program for 12 weeks. |
| Control | Active comparator | Other: Usual careParticipants will receive the usual care and non-hypertension related text messaging for 12 weeks. |
Who may qualify
- Ages
- 45 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Own a mobile phone and able to use
- Able to communicate with Cantonese and read Chinese
- Diagnosed with hypertension and taking at least one anti-hypertensive medication
- SBP = 131~159 mmHg or DBP = 81~99 mmHg
Key exclusion criteria (2 listed)
- Renal hypertension
- Mini-Cog < 3
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 |
|---|---|---|
| Educational program for hypertensive patientsThe theory-guided program consisted of one session of health education, self-developed leaflet, and weekly text messaging for 12 weeks. | Other | Intervention |
| Usual careOne standardized health education and a leaflet developed by the Health Bureau. As similar as the intervention group, weekly text messaging will be delivered, but the content is not related to the blood pressure control. | Other | Control |
Primary outcome
Change of blood pressure at week 8 and week 12
Time frame: Baseline, week 8, week 12
Systolic and diastolic blood pressure (mmHg) is measured by a trained research assistant. A validated upper-arm blood pressure monitor is used for the blood pressure measurement.
2 secondary outcomes
Change of Treatment Adherence Questionnaire for Patients with Hypertension (TAQPH) at week 8 and week 12
Time frame: Baseline, week 8, week 12
Change of Self-efficacy for managing chronic disease (SEMCD) at week 8 and week 12
Time frame: Baseline, week 8, week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Derived from this study: PubMed 37295501Tam HL, Wong EML, Cheung K. Educational Program with Text Messaging for Community-Dwelling Patients with Hypertension: A Pilot Randomized Controlled Trial. Asian Nurs Res (Korean Soc Nurs Sci). 2023 Aug;17(3):158-166. doi: 10.1016/j.anr.2023.06.001. Epub 2023 Jun 7.
- 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.
Eliza Mi Ling Wong, Dr principal investigator
The Hong Kong Polytechnic 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 Educational program for hypertensive patients in people with Hypertension,Essential, run by The Hong Kong Polytechnic University 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 4 inclusion and 2 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 4 Aug 2021. 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 China, Hong Kong. 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 Hon Lon Tam, MSc ((852) 3400 3804, hon-lon.tam@connect.polyu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of blood pressure at week 8 and week 12 (time frame: Baseline, week 8, week 12). 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 NCT04565548, 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 4 Aug 2021; AzTrials last refreshed its copy on 30 Oct 2026.