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

Primary Hypertension Clinical Trial

— "MaRiTensi"  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06049862
• Other study ID #: KE/FK/0186/EC
• Status: Recruiting
• Phase: N/A
• Start date: October 11, 2023
• Est. completion date: April 2024

Study information

• Verified date: November 2023
• Source: Gadjah Mada University
• Contact: Chatarina S Widyastuti, Sp.Kep.M.B
• Phone: +62 813-2884-2319
• Email: chatarinasetyawidyastuti0675[@]mail.ugm.ac.id
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 blood pressure in the intervention group compared to the control group.

Respondent recruitment is as follows:

1. The respondent candidate will be identified based on data on record medical

2. Appropriate respondent candidates' criteria inclusion and exclusion contacted for given informed consent

3. Prospective respondents who are willing to participate and fulfill the criteria for pressure blood moment measurement will request signed consent

4. Respondents fill in the basic data and recapitulate by the assistant researcher

5. Done randomization for allocation of group interventions and group control

6. Respondents given envelope closed (using sequentially numbered, opaque sealed envelopes (SNOSE) method )

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.

Description:

Participants will be separated into two groups.

1. Respondents who have given consent will be given two questionnaires

2. Intervention group respondents will be given intervention for 12 weeks

3. 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:

1. 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)

2. Respondents were given a password to enter their data and log in to the "MaRiTensi" application.

3. Respondents will be given a simple and easy-to-understand tutorial on how to use "MaRiTensi."

4. Respondents measure blood pressure at least twice a week according to standards and record the results in the application

5. Respondents utilized every feature in MaRiTensi according to the needs of each respondent, including the question-and-answer feature

6. 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

7. 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:

1. 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.

2. 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)

3. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

According to the doctor's diagnosis based on ICD 10:

1. Renal failure (ICD: N17-N19)

2. Diabetes Mellitus (ICD: E10-E14.9)

3. Stroke (ICD: I60-I69.8)

4. Acute Miocard Infarction (AMI) (ICD: I21-I21.9)

5. Heart Failure (ICD: I50-I50.9)

6. Cancer (ICD: C00-C97)

7. Dementia (ICD: F00-F04)

8. Mental disorders (ICD: F05-F99.9)

9. Thyroid Disease (ICD: E00-E07.9)

10. Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS) (ICD:

B20)

11. 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)

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension
• Primary Hypertension

Intervention

Behavioral:
• MaRiTensi App
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.

Locations

Country	Name	City	State
Indonesia	Puskesmas Depok 2	Sleman	D.I Yogyakarta
Indonesia	Puskesmas Pakem	Sleman	DI Yogyakarta
Indonesia	Panti Rapih Hospital	Yogyakarta

Sponsors (2)

Lead Sponsor	Collaborator
Chatarina Setya Widyastuti	Gadjah Mada University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	up to 12 weeks