Primary Hypertension"MaRiTensi"NCT06049862
The Effectiveness of "MaRiTensi" in Increasing Self-Care and Blood Pressure Control: Randomized Controlled Trial
A study testing MaRiTensi App in people with Primary Hypertension, run by Chatarina Setya Widyastuti at 3 sites in Indonesia.
Trial summary
This study aims to know the effectiveness of "MaRiTensi" in improving knowledge, motivation, efficacy, self-care and blood pressure control for hypertension patients. This study hypothesizes that MaRiTensi effectively increases the knowledge, motivation, self-efficacy and self-care of hypertensive patients and reduces… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Primary Hypertension
- What is being tested?
- MaRiTensi App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 3 sitesIndonesia
- Study dates
- 11 Oct 2023to 28 Apr 2024
- Phase
- Interventional
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A patient registered in the medical record of RSPR, the doctor diagnosed with hypertension based on ICD 10: I10; Age 18 to <60 years; owning and being able to use a smartphone; living in Yogyakarta during the study period; blood pressure ≥ 140/90 mmHg measured at the time of visit.
Who cannot join
- According to the doctor's diagnosis based on ICD 10:
- Renal failure (ICD: N17-N19)
- Diabetes Mellitus (ICD: E10-E14.9)
- Stroke (ICD: I60-I69.8)
- Acute Miocard Infarction (AMI) (ICD: I21-I21.9)
- Heart Failure (ICD: I50-I50.9)
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- Cancer (ICD: C00-C97)
- Dementia (ICD: F00-F04)
- Mental disorders (ICD: F05-F99.9)
- Thyroid Disease (ICD: E00-E07.9)
- Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS) (ICD: B20)
- Movement limitations: Hernia Nucleus Pulposus (HNP) (ICD: M50-M51.9); Piriformis Syndrome (ICD: G57-G57.9); Low Back Pain (LBP) (ICD: M54-M54.9); Frozen Shoulder (ICD: M75-75.9)
Trial locations and contacts
3 sites in 1 country.
Indonesia3 sites
Puskesmas Depok 2
Sleman, D.I Yogyakarta, 55283
Puskesmas Pakem
Sleman, DI Yogyakarta, 55582
Panti Rapih Hospital
Yogyakarta, 55223
About this study
Official title: "MaRiTensi" SELF MANAGEMENT APPLICATION FOR HYPERTENSION PATIENTS BASED ON M-HEALTH Its Effectiveness In Increasing Self- Care And Controlling Pressure Blood: Randomized Controlled Trial
This study aims to know the effectiveness of "MaRiTensi" in improving knowledge, motivation, efficacy, self-care and blood pressure control for hypertension patients.
This study hypothesizes that MaRiTensi effectively increases the knowledge, motivation, self-efficacy and self-care of hypertensive patients and reduces blood pressure in the intervention group compared to the control group.
Read more
Respondent recruitment is as follows:
- The respondent candidate will be identified based on data on record medical
- Appropriate respondent candidates' criteria inclusion and exclusion contacted for given informed consent
- Prospective respondents who are willing to participate and fulfill the criteria for pressure blood moment measurement will request signed consent
- Respondents fill in the basic data and recapitulate by the assistant researcher
- Done randomization for allocation of group interventions and group control
- Respondents given envelope closed (using sequentially numbered, opaque sealed envelopes (SNOSE) method )
- Respondents' group intervention was given maintenance by Hospital or health center standard-added intervention using MaRiTensi by conditions; meanwhile, group control was provided care by Hospital or health center standards.
Read the detailed description
Participants will be separated into two groups.
- Respondents who have given consent will be given two questionnaires
- Intervention group respondents will be given intervention for 12 weeks
- Control group respondents will receive services according to the hospital or health center standards. Respondents will be asked to complete a questionnaire for the first evaluation during the first week of week six and to fill out a questionnaire for the final assessment in week 12.
Interventions in the form of utilizing "MaRiTensi" by the intervention group are given with the following conditions:
- Intervention group and control group respondents filled out the Indonesian Version of the hypertension knowledge-level scale (HK-LS) questionnaire and the Indonesian Version of the Hypertension Self-care Profile (HBP-SCP)
- Respondents were given a password to enter their data and log in to the "MaRiTensi" application.
- Respondents will be given a simple and easy-to-understand tutorial on how to use "MaRiTensi."
- Respondents measure blood pressure at least twice a week according to standards and record the results in the application
- Respondents utilized every feature in MaRiTensi according to the needs of each respondent, including the question-and-answer feature
- Respondents will be evaluated by telephone every two weeks by a research assistant to determine whether the respondent is following the intervention according to the procedure. Respondents who did not comply with the system were classified as lost follow-up
- After using the "MaRiTensi" application, a post-test will be carried out at week six and week 12 using the Indonesian Version of the hypertension knowledge-level scale (HK-LS) and the Indonesian Version of the Hypertension Self-care Profile (HBP-SCP) questionnaire.
Data analysis in the third phase of the research was carried out by:
- Editing Data originating from filling out the Indonesian Version of the hypertension knowledge scale (HK-LS) questionnaire and the Indonesian Version of the Hypertension Self-care Profile (HBP-SCP), as well as recording blood pressure in the application, will be examined for completeness, if there is incomplete data then will be asked back to the respondent to complete it.
- Coding Coding will be provided for each questionnaire filled by respondents, especially for quantitative data according to the data scale. Coding is given according to the provisions in filling out the questionnaire (attached)
- Tabulating Tabulating is done to convey respondents' demographic data in the third research and data on blood pressure, knowledge, motivation, self-efficacy, and self-care of hypertensive patients, as well as the results of the effectiveness analysis of "MaRiTensi" on these variables.
The data will be analyzed statistically using the paired t-test to analyze the first and second pre-test and post-test results. Comparison between the intervention and control groups will be analyzed by independent t-test. The first and second post-test outcome data will be subjected to an ANOVA test. All databases will be stored by researchers and validated by assessors, managed in a folder with a password so that not all teams can open it. Data analysis was carried out by the analyst, who performed it in a hidden manner, and the researcher will accept the data processing results for analysis to continue.
- Conditions
- Primary Hypertension
- Being tested
- MaRiTensi App
- Keywords
- Hypertension, Mobile Health, Self-Management
- 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.
MaRiTensi AppBehavioural
MaRiTensi is a mobile health-based hypertension self-management application used on Android smartphones.
MariTensi provides facilities for recording blood pressure, BMI, activity, examination results, education about hypertension, consultations, reminders and community chat.
| Study group | Role | What they receive |
|---|---|---|
| MariTensi app and usual care | Experimental | Patients use the MaRitensi application to manage their hypertension by utilizing various menus in the application and continue receiving treatment as usual for 12 weeks. Receives: Behavioral: MaRiTensi App |
| Usual care | No intervention | The patient was not given the MaRitensi application and only received treatment as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of knowledge of hypertensive patients about hypertension
Everything that hypertensive patients know about, definitions, medical drugs, drug adherence, lifestyle, diet, and complications as measured by 22 questions using the Indonesian version of the HK-LS questionnaire
Measured: up to 12 weeks
The motivation of hypertensive patients
The desire of hypertensive patients to take action to manage their hypertension as measured by 20 questions using the Indonesian version of the HBP-SCP questionnaire
Measured: up to 12 weeks
Self-efficacy of hypertensive patients
A hypertensive patient's belief that he can manage his hypertension well as measured by 20 questions using the Indonesian version of the HBP-SCP questionnaire
Measured: up to 12 weeks
Self-care of hypertensive patients
Actions initiated and performed by hypertensive patients to manage their disease as measured by 20 questions about self-management of hypertensive patients using the Indonesian version of the HBP-SCP questionnaire
Measured: up to 12 weeks
Blood Pressure Control
A condition in which hypertensive patients can control their blood pressure. The criterion that blood pressure is under control if it meets 1 of the following criteria:
- There were no additional antihypertensive drugs during the study period
- There were no additional doses of antihypertensive drugs during the study period
- Blood pressure <140 mmHg at the first and second evaluation
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start11 Oct 2023
- Primary completion28 Apr 2024
- Study completion28 Apr 2024
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 Primary 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention was given in the third phase of the research, namely "MaRiTensi," which was developed in the first and second stages of the research.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chatarina Setya Widyastuti
- Sponsor type
- University, hospital or other
- Collaborators
- Gadjah Mada University
- Responsible party
- Sponsor-investigator, Chatarina Setya Widyastuti, Gadjah Mada University
- Investigators
- Chatarina S Widyastuti, Study chair, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049862
- Sponsor's protocol ID
- KE/FK/0186/EC
- Acronym
- "MaRiTensi"
- Status last verified
- Jul 2024
- First submitted
- 11 Sep 2023
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data share to other reseacher for data analysis because there is a mask in data analysis in this study
Publications
Widyastuti CS, Dinarti LK, Aulawi K, Lazuardi L. Effectiveness of mHealth on self-care profile and blood pressure among patients with hypertension in Indonesia: A single-blind randomized controlled trial. Belitung Nurs J. 2025 May 27;11(3):294-304. doi: 10.33546/bnj.3760. eCollection 2025.
PubMed 40438651