The Effectiveness of "MaRiTensi" in Increasing Self-Care and Blood Pressure Control: Randomized Controlled Trial

NCT06049862 | Completed

• 1 other identifier: KE/FK/0186/EC
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 3

Brief 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 blood pressure in the intervention group compared to the control group. Respondent recruitment is as follows:

1. 1.The respondent candidate will be identified based on data on record medical
2. 2.Appropriate respondent candidates' criteria inclusion and exclusion contacted for given informed consent
3. 3.Prospective respondents who are willing to participate and fulfill the criteria for pressure blood moment measurement will request signed consent
4. 4.Respondents fill in the basic data and recapitulate by the assistant researcher
5. 5.Done randomization for allocation of group interventions and group control
6. 6.Respondents given envelope closed (using sequentially numbered, opaque sealed envelopes (SNOSE) method )
7. 7.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.

Conditions

Primary Hypertension

Keywords

Hypertension; Mobile Health; Self-Management

Outcome Measures

Primary Outcomes (5)

• 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

  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

  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

  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

  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: 1. There were no additional antihypertensive drugs during the study period 2. There were no additional doses of antihypertensive drugs during the study period 3. Blood pressure \<140 mmHg at the first and second evaluation

  up to 12 weeks

Study Arms (2)

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.

Behavioral: MaRiTensi App

Usual care

NO INTERVENTION

The patient was not given the MaRitensi application and only received treatment as usual.

Interventions

MaRiTensi App BEHAVIORAL

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.

MariTensi app and usual care

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• Chatarina Setya Widyastuti: lead
• Gadjah Mada University: collaborator

Study Sites (3)

Puskesmas Depok 2

Sleman, D.I Yogyakarta, 55283, Indonesia

Location

Puskesmas Pakem

Sleman, DI Yogyakarta, 55582, Indonesia

Location

Panti Rapih Hospital

Yogyakarta, 55223, Indonesia

Location

Related Publications (1)

• 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.

  PMID: 40438651 DERIVED

MeSH Terms

Conditions

Essential Hypertension; Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Chatarina S Widyastuti

  Gadjah Mada University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: In the research, the third stage will do double-blinding for the care provider and outcome assessor, who will evaluate blood pressure and questionnaires. Allocation concealment for dividing into groups, intervention and control will use the SNOSE (sequentially numbered, opaque sealed envelopes ) method. The envelope closed will be sorted by order randomization, given paper carbon with appearance. The same is true for envelopes with the inscription intervention or control.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: S.Kep.,Ns.,M.Kep.,Sp.Kep.M.B

Model Details: 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.

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 22, 2023
• Study Start: October 11, 2023
• Primary Completion: April 28, 2024
• Study Completion: April 28, 2024
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: during study period
• Access Criteria: numeric data for data analysis

Locations

ID (3)