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

Primary Purpose

Primary Hypertension

Status
Not yet recruiting
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
MaRiTensi App
Sponsored by
Chatarina Setya Widyastuti
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Primary Hypertension focused on measuring Hypertension, Mobile Health, Self-Management

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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: 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)

Sites / Locations

  • Puskesmas Pakem

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MariTensi app and usual care

Usual care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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
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
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
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
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

Secondary Outcome Measures

Full Information

First Posted
September 11, 2023
Last Updated
September 16, 2023
Sponsor
Chatarina Setya Widyastuti
Collaborators
Gadjah Mada University
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1. Study Identification

Unique Protocol Identification Number
NCT06049862
Brief Title
The Effectiveness of "MaRiTensi" in Increasing Self-Care and Blood Pressure Control: Randomized Controlled Trial
Acronym
"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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Chatarina Setya Widyastuti
Collaborators
Gadjah Mada University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hypertension
Keywords
Hypertension, Mobile Health, Self-Management

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Care ProviderOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MariTensi app and usual care
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
The patient was not given the MaRitensi application and only received treatment as usual.
Intervention Type
Behavioral
Intervention Name(s)
MaRiTensi App
Intervention Description
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.
Primary Outcome Measure Information:
Title
The level of knowledge of hypertensive patients about hypertension
Description
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
Time Frame
up to 12 weeks
Title
The motivation of hypertensive patients
Description
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
Time Frame
up to 12 weeks
Title
Self-efficacy of hypertensive patients
Description
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
Time Frame
up to 12 weeks
Title
Self-care of hypertensive patients
Description
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
Time Frame
up to 12 weeks
Title
Blood Pressure Control
Description
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
Time Frame
up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chatarina S Widyastuti, Sp.Kep.M.B
Phone
+62 813-2884-2319
Email
chatarinasetyawidyastuti0675@mail.ugm.ac.id
First Name & Middle Initial & Last Name or Official Title & Degree
Lucia Krisdinarti, Profesor
Phone
+62 812-2578-4061
Email
kris_dinarti@ugm.ac.id
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chatarina S Widyastuti
Organizational Affiliation
Gadjah Mada University
Official's Role
Study Chair
Facility Information:
Facility Name
Puskesmas Pakem
City
Sleman
State/Province
DI Yogyakarta
ZIP/Postal Code
55582
Country
Indonesia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chatarina S Widyastuti, Sp.Kep.M.B
Phone
+62 813-2884-2319
Email
chatarinasetyawidyastuti0675@mail.ugm.ac.id
First Name & Middle Initial & Last Name & Degree
Fitri
Phone
+62 823-1445-3313

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data share to other reseacher for data analysis because there is a mask in data analysis in this study
IPD Sharing Time Frame
during study period
IPD Sharing Access Criteria
numeric data for data analysis

Learn more about this trial

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

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