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

NCT05263726 | Completed

• 1 other identifier: CTH-109-3-1-062
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Self-management; Mobile Applications

Keywords

mobile applications; hypertension; disease self-management program; mental health; self-management; quality of life

Outcome Measures

Primary Outcomes (1)

• The Partner in Health Scale (PIH)

  This scale is a generic tool that was developed for measuring self-management knowledge and behaviors in patients with chronic illnesses (Battersby et al., 2003). Original scale includes 11 items, contains five properties. The internal consistency reliability Cronbach's α value of this scale is .88. Then redefinition the six major principles of chronic condition self-management including disease knowledge, adherence to a treatment plan made in accordance with the healthcare provider, playing an active role in the decision-making process, awareness of warning symptoms and their management, coping with the effects the of the chronic illness in relation to the physical, mental and social aspects of life and practice of a healthy lifestyle. The PIH scale is a self-report questionnaire that includes 12 items, which are answered using 9-point Likert-type scales (from 0 "very poor" to 8 "very well"). The total score ranges from 0 to 96, 0 representing poor self-management and 96 representing

  Change from Baseline Disease Self-management at 3 months.

Secondary Outcomes (2)

• World Health Organization-5 Well Being Index (WHO-5)

  Change from Baseline Mental Health at 3 months.

• Medical Outcome Study Short Form-12 (MOS SF-12)

  Change from Baseline quality of life at 3 months.

Study Arms (2)

DSMP through a mobile applications

EXPERIMENTAL

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.

Behavioral: DSMP through a Mobile Applications

Usual Care

NO INTERVENTION

Routine care

Interventions

DSMP through a Mobile Applications 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.

DSMP through a mobile applications

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: lead
• Cardinal Tien Hospital: collaborator

Study Sites (1)

Cardinal Tien Hospital

New Taipei City, 23148, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 40084962 DERIVED

Related Links

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

MeSH Terms

Conditions

Hypertension; Psychological Well-Being

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Personal Satisfaction; Behavior

Study Officials

• Mei-Chen Lee, PhD

  National Taipei University of Nursing and Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, PhD, Associate Professor

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: March 3, 2022
• Study Start: February 8, 2022
• Primary Completion: January 30, 2023
• Study Completion: January 30, 2023
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)