The Effect of a Disease Self-management Program Through a Mobile Applications for Patients With Hypertension

NCT ID: NCT05263726

Last Updated: 2023-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-08
• Study Completion Date: 2023-01-30

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.

Conditions

Hypertension; Self-management; Mobile Applications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

DSMP through a mobile applications

This interventional divided the disease self-management program manual for patients with hypertension into 4 units, including: Unit 1: hypertension brief introduction and complications. Unit 2: dietary precautions for patients with hypertension. Unit 3: medication treatments for patients with hypertension. Unit 4: the content included stress management (emotional control, spiritual support) of patients with hypertension. 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 researcher used the back office administration at the computer end to observe how the experimental group operated and used the mobile devices. The effect of interventions was then evaluated after three months when the patients returned.

Group Type: EXPERIMENTAL

DSMP through a Mobile Applications

Intervention Type: BEHAVIORAL

This interventional divided the disease self-management program manual for patients with hypertension into 4 units, including: Unit 1: hypertension brief introduction and complications. Unit 2: dietary precautions for patients with hypertension. Unit 3: medication treatments for patients with hypertension. Unit 4: the content included stress management (emotional control, spiritual support) of patients with hypertension. 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 researcher used the back office administration at the computer end to observe how the experimental group operated and used the mobile devices. The effect of interventions was then evaluated after three months when the patients returned.

Usual Care

Routine care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

DSMP through a Mobile Applications

This interventional divided the disease self-management program manual for patients with hypertension into 4 units, including: Unit 1: hypertension brief introduction and complications. Unit 2: dietary precautions for patients with hypertension. Unit 3: medication treatments for patients with hypertension. Unit 4: the content included stress management (emotional control, spiritual support) of patients with hypertension. 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 researcher used the back office administration at the computer end to observe how the experimental group operated and used the mobile devices. The effect of interventions was then evaluated after three months when the patients returned.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cardinal Tien Hospital

OTHER

Sponsor Role: collaborator

National Taipei University of Nursing and Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Mei-Chen Lee

RN, PhD, Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mei-Chen Lee, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taipei University of Nursing and Health Sciences

Locations

Cardinal Tien Hospital

New Taipei City, , Taiwan

Countries

Taiwan

References

Chen CW, Lu YY, Lin LJ, Liu JH, Lee MC, Wu SV. Using a Mobile Application Disease Self-management Program to Promote Blood Pressure Control and Quality of Life in Patients With Hypertension. Comput Inform Nurs. 2025 Mar 14. doi: 10.1097/CIN.0000000000001296. Online ahead of print.

Reference Type: DERIVED

PMID: 40084962 (View on PubMed)

Related Links

https://doi.org/10.1097/MD.0000000000019715

Mobile health applications for the management of primary hypertension: A multicenter, randomized, controlled trial.

https://doi.org/10.1016/j.ijnurstu.2018.11.007

The effectiveness of electronic health interventions on blood pressure control, self-care behavioral outcomes and psychosocial well-being in patients with hypertension: A systematic review and meta-analysis.

Other Identifiers

CTH-109-3-1-062

Identifier Type: -

Identifier Source: org_study_id