Clinical trial NCT05263726: The Effect of a Disease Self-management Program Through a Mobile Applications for Patients With Hypertension
Official title: The Effect of a Disease Self-management Program Through a Mobile Applications for Patients With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Self-management
Mobile Applications
Keywords: mobile applications
hypertension
disease self-management program
mental health
self-management
quality of life
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
Collaborators: name: Cardinal Tien Hospital
First posted: 2022-03-03
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Hypertension is a major cause of death worldwide. Patients should adjust their lifestyle and learn how to maintain a balance between self-management of a disease and their daily livelihood. Knowledge is networked, mobile devices can be used as a way of health education. The purpose of this study is to evaluation the effectiveness of the disease self-management program through a mobile applications for patients with hypertension. Statistical analyses was used analysis of covariance for checking the effect of interventions. Through the calculation by a statistical power analysis formula, the study takes 70 samples and divides them into a control group (usual care) and an experimental group (disease self-management program through a mobile applications) by the single blind randomized controlled trial, whereby each groups has 35 samples. The first step investigate the physiological indicators, mental health, self-management, quality of life of the patients. For the experimental group, after the pre-test the study set up a health guide for the disease self-management program with a mobile applications. The experimental group received the mobile apps educational program for at least 30 minutes each session and at least once every two days. After two weeks and six weeks, a follow-up telephone interview helped to strengthen the health self-management self-confidence. The effect of interventions was then evaluated after three months when the patients returned. Therefore, the self-management of a disease can be improved and patients will learn to live in harmony with hypertension by improving their mental health, self-management, and quality of life.

Detailed description: Due to the aging population and the advancement of medical science and technology, people's lives have been extended longer in years, but at the same time the prevalence rate of chronic diseases is increasing. Hypertension may cause several complications, resulting in abnormal organs either chronically or deadly. Patients should adjust their lifestyle and learn how to maintain a balance between self-management of a disease and their daily livelihood. Knowledge is networked, mobile devices can be used as a way of health education. Therefore, this research builds a disease self-management program through a mobile applications that runs in accordance with expert validity, so as to effectively control hypertension and avoid its complications. SPSS/Windows 22.0 helped with filing and statistical analyses, and analysis of covariance (ANCOVA) was used for checking the effect of interventions. Through the calculation by a statistical power analysis formula, the study takes 70 samples and divides them into a control group (usual care) and an experimental group (disease self-management program through a mobile applications) by the single blind random control trial, whereby each groups has 35 subjects. The first step tests the physiological indicators, mental health, self-management, and quality of life of the patients. For the experimental group, after the pre-test the study set up a health guide for the disease self-management program with a mobile applications. The experimental group received the mobile apps educational program for at least 30 minutes each session and at least once every two days. After two weeks and six weeks, a follow-up telephone interview helped to strengthen the health self-management self-confidence. The effect of interventions was then evaluated after three months when the patients returned. The findings are expected to effectively control patients' hypertension in Taiwan after completing the research plan. Therefore, the self-management of a disease can be improved and patients will learn to live in harmony with hypertension by improving their mental health, self-management, and quality of life.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Hypertension Disease
* A clear state of consciousness and without diagnosis of mental illness
* Can communicate in Chinese and Taiwanese and are willing to participate in this study
* Age 18 years old the above

Exclusion Criteria:

* Cognitive dysfunction who are unable to understand the questionnaire
* Mental illness (severe depression, schizophrenia) reported in the medical records.

Primary outcomes:
measure: The Partner in Health Scale (PIH)
timeFrame: Change from Baseline Disease Self-management at 3 months.
Secondary outcomes:
measure: World Health Organization-5 Well Being Index (WHO-5)
timeFrame: Change from Baseline Mental Health at 3 months.
measure: Medical Outcome Study Short Form-12 (MOS SF-12)
timeFrame: Change from Baseline quality of life at 3 months.
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Cardinal Tien Hospital
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences
name: Mei-Chen Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References: