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HypertensionNCT05263726

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

A study testing DSMP through a Mobile Applications in people with Hypertension and Self-management, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension, Self-management, Mobile Applications
What is being tested?
DSMP through a Mobile Applications
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteTaiwan
Study dates
8 Feb 2022to 30 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Cardinal Tien Hospital

    New Taipei City, 23148

Other trials in Taiwan

About this study

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.

Read the 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.

Being tested
DSMP through a Mobile Applications
Keywords
mobile applications, hypertension, disease self-management program, mental health, self-management, quality of life
Medical subject headings
Hypertension, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DSMP through a Mobile ApplicationsBehavioural

    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.

Study groups in NCT05263726
Study groupRoleWhat they receive
DSMP through a mobile applicationsExperimentalThis 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.
Receives: Behavioral: DSMP through a Mobile Applications
Usual CareNo interventionRoutine care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Change from Baseline Disease Self-management at 3 months.

Secondary outcomes (2)

  1. World Health Organization-5 Well Being Index (WHO-5)

    This scale is a 5-item questionnaire. The scoring included 0 point (at no time), representing the worst to 5 points (all of the time), representing the best. The total score ranges from 0 to 25 points. Patients whose total score is lower than 13 points or whose answer to any of the 5 items is 0 to 1 point are recommended to receive the test of severe depression scale or review a face-to-face interview with a psychologist to check whether they meet the medical diagnosis of depression. The internal consistency reliability Cronbach's α value of this scale is .87. The test-retest reliability of this scale in Germany and Japan is Cronbach's α .90 (Saipanish, Lotrakul, \& Sumrithe, 2009). The internal consistency reliability Cronbach's α value of this scale in Taiwan is Cronbach's α .89 (Lee et al., 2021)

    Measured: Change from Baseline Mental Health at 3 months.

  2. Medical Outcome Study Short Form-12 (MOS SF-12)

    Both the SF-12 and SF-36 quality of life scales are derived from the Medical Outcomes Study (MOS). SF-12 was finalized in 1994, with a total of 12 questions in two dimensions, PCS and MCS, which were four reverse questions (questions 1, 5, 6a, and 6b) that needed to be scored in reverse first. As the measuring scale and scoring method of each question are different, it must be converted to the order of 0-100 points, where 100 points indicates the best condition. The total score of all questions are divided by 12 to obtain the total score of the scale, which ranges from 0 to 120 points, the higher the score, the better the quality of life of the patients. In 2021, Chen et al. (2021) used the SF-12 scale to measure patients with hypertensive nephropathy. The results showed that the internal consistency Cronbach's α values of SF-12 were 0.88, 0.87, and 0.87, respectively, for the overall quality of life, quality of life in the PCS, and quality of life in the MCS.

    Measured: Change from Baseline quality of life at 3 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2022
  2. Study start8 Feb 2022
  3. Primary completion30 Jan 2023
  4. Study completion30 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05263726
Sponsor's protocol ID
CTH-109-3-1-062
Status last verified
Mar 2023
First submitted
14 Feb 2022
Last updated
23 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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. 2026 Mar 1;44(3):e01296. doi: 10.1097/CIN.0000000000001296.

    PubMed 40084962

  • Lee MC, Liu CC, Wang WH, Lin MH, Liao PH, Chen MQ. Effectiveness of Mobile Application Disease Self-Management Programme on Mental Health and Self-Management of Patients With Hypertension: A Randomised Controlled Trial. Int J Nurs Pract. 2024 Dec;30(6):e13312. doi: 10.1111/ijn.13312. Epub 2024 Oct 21.

    PubMed 39431412

Questions about this trial

What is this clinical trial studying?

A study testing DSMP through a Mobile Applications in people with Hypertension and Self-management, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Partner in Health Scale (PIH) (time frame: Change from Baseline Disease Self-management at 3 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05263726, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.

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