HypertensionNCT06666361
Middle-aged and Older Adults with Hypertension in Rural Communities
A study testing Experimental Group in people with Hypertension, run by Chimei Medical Center at 1 site in Taiwan.
Trial summary
Does the m-Health intervention have a positive effect on the health literacy and health promotion behaviors of the study participants? Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Experimental Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Dec 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with hypertension for one year or more (including) and controlled with medication (systolic blood pressure ≥ 130 mmHg and diastolic blood pressure ≥ 80 mmHg).
- Aware hypertensive patients aged ≥ 45 years with the ability to read and write.
- Able to take medication independently.
- Own a smartphone and are able to use it, and are willing to receive text messages (TxtM) or mobile health interventions (m-Health).
- Agree to participate in the study.
Who cannot join
- Have cognitive impairments or mental disorders.
- CCI (Charlson Comorbidity Index) score ≥ 3.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Chi Mei Hospital, Liouying
Tainan, Taiwan, 73657
Man-Ting cheng, +886 961062509, hate6699@gmail.com
About this study
Official title: Health Literacy and Health Promotion Behaviors Among Middle-aged and Older Adults with Hypertension in Rural Communities: a Mixed Methods Study
Does the m-Health intervention have a positive effect on the health literacy and health promotion behaviors of the study participants?
Read the detailed description
This study adopted a mixed methods study, and the first stage was a qualitative research design. The second phase was a quantitative research design aims to evaluate the effectiveness of applying healthy lifestyle intervention on the health literacy and health promotion behaviors among middle-aged and older adults with hypertension in rural communities. Recruitment is planned to be conducted in the cardiology outpatient clinic of a regional teaching hospital in the south. It will be a random assignment, single-blind, experimental research design, using simple random sampling to assign to the experimental group and the control group (experimental group: hypertension health education manual + m-Health; control group: hypertension health education manual), a two- month intervention program was carried out, and the questionnaire survey was conducted three times: once as a pre-test and twice as post-tests (during the 4th week and the 8th week of the intervention). Data analysis was conducted using statistical software (SPSS, version 22.0) for data management and statistical analysis, and analysis was conducted using descriptive statistics, independent sample t-test, chi-square test, and generalized estimating equations (GEE).
- Conditions
- Hypertension
- Being tested
- Experimental Group, control group
- Keywords
- Hypertension, rural, health literacy, health promotion, middle-aged and older adults
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental GroupOther
The experimental group participates in the Mobio Health Multimedia Hypertension Promotion Program, which includes a hypertension education manual and a mobile health (m-health) intervention aimed at enhancing participants' health literacy and promoting healthy behaviors. In the first week, participants receive the health-education manual on-site, with face-to-face explanations and guidance on using mobile resources, such as text messaging, provided by the Sub-Investigator.
The mobile health intervention transforms the manual's content into six video units, each covering a specific topic, and these videos are continuously pushed over a two-month period. Distributed through LINE@, the official LINE account of the nursing platform, participants can easily access information via the chat menu at the bottom of the screen. This setup improves accessibility, making it convenient for participants to locate and use essential health information directly from the chat window.
control groupOther
The control group received one copy of the same health education manual as the experimental group. The sub-Investigator only explained how to use the manual, and afterwards, no face-to-face teaching or m-Health interventions were conducted. After the experiment concluded, the m-Health program used by the experimental group would be provided to the control group.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group:receiving intervention | Experimental | The experimental group participates in the Mobio Health Multimedia Hypertension Education Program, which includes a hypertension health education manual and a mobile health (m-health) intervention, aimed at enhancing participants' health literacy and promoting health-enhancing behaviors. Receives: Other: Experimental Group |
| Control group :Non intervention | Experimental | In the control group, participants received the same hypertension health education manual as the experimental group. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
1.To explore the effectiveness of mobile health(m-health) interventions on the health literacy of study participants. 2.To explore the effectiveness of mobile health(m-health) interventions on the health promotion behaviors of study participants.
A structured questionnaire survery was administered at the start, and at the 4th and 8th weeks of the intervention to evaluate its effectiveness. The questionnaire includes:(1) The Hypertension Health Literacy Scale, with scores ranging from 10 to 40, where higher scores indicate better outcomes; (2) The short-form Chinese Health-Promoting Lifestyle Profile, with scores ranging from 24 to 96, where higher scores indicate better outcomes.
Measured: 1.Total duration for Each Participant: 2 months Intervention Period: From December 2024 to December 2025
Secondary outcomes (1)
1.To explore the factors influencing the health literacy of study participants. 2.To explore the factors influencing the health promotion behaviors of study participants.
A structured questionnaire was administered at the start, at weeks 4 and 8 of the intervention, and for post-intervention evaluation. The details are as follows: (1) Basic Characteristics, including age , gender, height (cm), weight (kg), BMI(weight and height will be combined to report BMI in in kg/m²), education, marital status, residential area, employment, economic status, living situation, clinic transportation, duration of hypertension, regular medication, and presence of other chronic diseases; (2) Hypertension Knowledge Scale( 0 to 10, higher scores = greater knowledge); (3) Adherence to Refills and Medications Scale (12-48, higher scores = better outcomes); (4) System Usability Scale, graded as: A (90-100), B (80-89), C (70-79), D (60-69), and F (0-59), with strong face validity and an average score of about 70; scores above 70 are considered acceptable; (5) Learning Satisfaction Questionnaire (12-60, higher scores= better outcomes).
Measured: 1.Total duration for Each Participant: 2 months Intervention. 2.Period: From December 2024 to December 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start7 Dec 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Participant
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chimei Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HSIAO,SU-CHIU, Chimei Medical Center
- Investigators
- Su.Chiu Hsiao, Principal investigator, Chi Mei Medical Center,Liouying Director Nursing Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06666361
- Sponsor's protocol ID
- CMMC11309-L01
- Other IDs
- IRB Serial No.: 11309-L01
- Status last verified
- Dec 2024
- First submitted
- 28 Oct 2024
- Last updated
- 10 Mar 2025
- 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 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Literacy and Health Promotion Behaviors Among Middle-aged and Older Adults with Hypertension in Rural Communities: a Mixed Methods Study
- ClinicalTrials.gov ID
- NCT06666361
- Acronym / sponsor ID
- CMMC11309-L01
- Conditions
- Hypertension
- Keywords
- Hypertension, rural, health literacy, health promotion, middle-aged and older adults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Chimei Medical CenterUniversity, hospital or other
- Study start
- 7 Dec 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 30 Oct 2024 (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.
Does the m-Health intervention have a positive effect on the health literacy and health promotion behaviors of the study participants?
Detailed description
This study adopted a mixed methods study, and the first stage was a qualitative research design. The second phase was a quantitative research design aims to evaluate the effectiveness of applying healthy lifestyle intervention on the health literacy and health promotion behaviors among middle-aged and older adults with hypertension in rural communities. Recruitment is planned to be conducted in the cardiology outpatient clinic of a regional teaching hospital in the south. It will be a random assignment, single-blind, experimental research design, using simple random sampling to assign to the experimental group and the control group (experimental group: hypertension health education manual + m-Health; control group: hypertension health education manual), a two- month intervention program was carried out, and the questionnaire survey was conducted three times: once as a pre-test and twice as post-tests (during the 4th week and the 8th week of the intervention). Data analysis was conducted using statistical software (SPSS, version 22.0) for data management and statistical analysis, and analysis was conducted using descriptive statistics, independent sample t-test, chi-square test, and generalized estimating equations (GEE).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group:receiving intervention | Experimental | Other: Experimental GroupThe experimental group participates in the Mobio Health Multimedia Hypertension Education Program, which includes a hypertension health education manual and a mobile health (m-health) intervention, aimed at enhancing participants' health literacy and promoting health-enhancing behaviors. |
| Control group :Non intervention | Experimental | Other: control groupIn the control group, participants received the same hypertension health education manual as the experimental group. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with hypertension for one year or more (including) and controlled with medication (systolic blood pressure ≥ 130 mmHg and diastolic blood pressure ≥ 80 mmHg).
- Aware hypertensive patients aged ≥ 45 years with the ability to read and write.
- Able to take medication independently.
- Own a smartphone and are able to use it, and are willing to receive text messages (TxtM) or mobile health interventions (m-Health).
- Agree to participate in the study.
Key exclusion criteria (2 listed)
- Have cognitive impairments or mental disorders.
- CCI (Charlson Comorbidity Index) score ≥ 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 |
|---|---|---|
| Experimental GroupThe experimental group participates in the Mobio Health Multimedia Hypertension Promotion Program, which includes a hypertension education manual and a mobile health (m-health) intervention aimed at enhancing participants' health literacy and promoting healthy behaviors. In the first week, participants receive the health-education manual on-site, with face-to-face explanations and guidance on using mobile resources, such as text messaging, provided by the Sub-Investigator. The mobile health intervention transforms the manual's content into six video units, each covering a specific topic, and these videos are continuously pushed over a two-month period. Distributed through LINE@, the official LINE account of the nursing platform, participants can easily access information via the chat menu at the bottom of the screen. This setup improves accessibility, making it convenient for participants to locate and use essential health information directly from the chat window. | Other | Experimental Group:receiving intervention |
| control groupThe control group received one copy of the same health education manual as the experimental group. The sub-Investigator only explained how to use the manual, and afterwards, no face-to-face teaching or m-Health interventions were conducted. After the experiment concluded, the m-Health program used by the experimental group would be provided to the control group. | Other | Control group :Non intervention |
Primary outcome
1.To explore the effectiveness of mobile health(m-health) interventions on the health literacy of study participants. 2.To explore the effectiveness of mobile health(m-health) interventions on the health promotion behaviors of study participants.
Time frame: 1.Total duration for Each Participant: 2 months Intervention Period: From December 2024 to December 2025
A structured questionnaire survery was administered at the start, and at the 4th and 8th weeks of the intervention to evaluate its effectiveness. The questionnaire includes:(1) The Hypertension Health Literacy Scale, with scores ranging from 10 to 40, where higher scores indicate better outcomes; (2) The short-form Chinese Health-Promoting Lifestyle Profile, with scores ranging from 24 to 96, where higher scores indicate better outcomes.
1 secondary outcome
1.To explore the factors influencing the health literacy of study participants. 2.To explore the factors influencing the health promotion behaviors of study participants.
Time frame: 1.Total duration for Each Participant: 2 months Intervention. 2.Period: From December 2024 to December 2025
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- 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.
Su.Chiu Hsiao principal investigator
Chi Mei Medical Center,Liouying Director Nursing Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Group in people with Hypertension, run by Chimei Medical Center at 1 site in Taiwan.
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 5 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: looking for participants now, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Man-Ting Cheng (+886 961062509, hate6699@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1.To explore the effectiveness of mobile health(m-health) interventions on the health literacy of study participants. 2.To explore the effectiveness of mobile health(m-health) interventions on the health promotion behaviors of study participants. (time frame: 1.Total duration for Each Participant: 2 months Intervention Period: From December 2024 to December 2025). 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 10 Mar 2025.