"MaRiTensi" SELF MANAGEMENT APPLICATION FOR HYPERTENSION PATIENTS BASED ON M-HEALTH Its Effectiveness In Increasing Self- Care And Controlling Pressure Blood: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 3
- 主要终点
- Self-efficacy of hypertensive patients
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
MariTensi app and usual care
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.
干预措施: MaRiTensi App (Behavioral)
Usual care
The patient was not given the MaRitensi application and only received treatment as usual.
结局指标
主要结局
Self-efficacy of hypertensive patients
时间窗: up to 12 weeks
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
Blood Pressure Control
时间窗: up to 12 weeks
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
The level of knowledge of hypertensive patients about hypertension
时间窗: up to 12 weeks
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
Self-care of hypertensive patients
时间窗: up to 12 weeks
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
The motivation of hypertensive patients
时间窗: up to 12 weeks
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
次要结局
未报告次要终点
研究者
Chatarina Setya Widyastuti
S.Kep.,Ns.,M.Kep.,Sp.Kep.M.B
Gadjah Mada University