Heart FailureAPPNCT05355506
The Development and Effectiveness of Heart Failure Self-Health Management Application
An observational study of Heart Failure, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial summary
Aims: To develop a smartphone application and investigate its effectiveness on patients with heart failure after using the "heart failure self-health management application.". Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Application
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2019to 3 Dec 2022
- How long will I take part?
- 8 Weeks
- Phase
- Observational
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inclusion Criteria: * Heart failure Exclusion Criteria: * Health
Who may be able to join
- Heart failure
Who cannot join
- Health
Trial locations and contacts
1 site in 1 country.
About this study
Official title: National Taipei University of Nursing and Science
Aims: To develop a smartphone application and investigate its effectiveness on patients with heart failure after using the "heart failure self-health management application.".
Read the detailed description
Abstract Aims: To develop a smartphone application and investigate its effectiveness on patients with heart failure after using the "heart failure self-health management application.".
Design: The single-group pre- and post-test experimental design was adopted. Methods: This study used convenience sampling and the one-group pretest and posttest design as the research methods and developed the "heart failure self-health management application" using the Google cloud database and Web App. The research period was from July 1 to December 31, 2019, a total of 36 patients diagnosed with heart failure during hospitalization completed the pretest and posttest. This App (1) provides text and video heart failure self-care knowledge content; (2) enables users to record and browse blood pressure, heart rate, and weight; and (3) provides the data from the Dutch Heart Failure Knowledge Scale and Technology Acceptance Model.
Keywords: heart failure; self-health management; application
- Conditions
- Heart Failure
- Being tested
- Application
- Keywords
- Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApplicationDevice
Knowledge \& record
| Study group | Role | What they receive |
|---|---|---|
| The Development and Effectiveness of Heart Failure Self-Health Management Application | Heart Failure can cause physical disability and death. According to the Ministry of Health and Welfare, there were 20,644 deaths from heart disease, ranking second among the top 10 causes of death [1]. The World Health Organization (WHO) has advocated nursing guidance with the concept of "empowerment", where patients can play an active and aggressive role in managing their health [2]. This paperless nursing health education guidance information can be designed through the application, which features non-professional expressions and visualization methods. The users can participate in feedback-based interactions and complete the questionnaires after receiving nursing guidance. This study used the Technology Acceptance Model (TAM) to evaluate patients' acceptance of the nursing guidance application and the effectiveness of such nursing guidance. Receives: Device: Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
participant's knowledge about heart failure significantly increased after the intervention
Provides the data from the Dutch Heart Failure Knowledge Scale and Technology Acceptance Model. Analysis on participant's knowledge about heart failure and Technology Acceptance Model Scale after the Intervention. Higher scores mean a better outcome.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start1 Jul 2019
- Primary completion3 Dec 2022 (estimated)
- Study completion3 Dec 2022 (estimated)
Why it stopped: covid-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 8 Weeks
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pei-Hung Liao, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355506
- Sponsor's protocol ID
- 19MMHIS04Oe
- Acronym
- APP
- Status last verified
- Apr 2022
- First submitted
- 11 Apr 2022
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Taipei University of Nursing and Science
- ClinicalTrials.gov ID
- NCT05355506
- Acronym / sponsor ID
- APP / 19MMHIS04Oe
- Conditions
- Heart Failure
- Keywords
- Heart Failure
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: covid-19
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 3 Dec 2022 (estimated)
- Study completion
- 3 Dec 2022 (estimated)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aims: To develop a smartphone application and investigate its effectiveness on patients with heart failure after using the "heart failure self-health management application.".
Detailed description
Abstract Aims: To develop a smartphone application and investigate its effectiveness on patients with heart failure after using the "heart failure self-health management application.".
Design: The single-group pre- and post-test experimental design was adopted. Methods: This study used convenience sampling and the one-group pretest and posttest design as the research methods and developed the "heart failure self-health management application" using the Google cloud database and Web App. The research period was from July 1 to December 31, 2019, a total of 36 patients diagnosed with heart failure during hospitalization completed the pretest and posttest. This App (1) provides text and video heart failure self-care knowledge content; (2) enables users to record and browse blood pressure, heart rate, and weight; and (3) provides the data from the Dutch Heart Failure Knowledge Scale and Technology Acceptance Model.
Keywords: heart failure; self-health management; application
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 8 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The Development and Effectiveness of Heart Failure Self-Health Management Application | – | Device: ApplicationHeart Failure can cause physical disability and death. According to the Ministry of Health and Welfare, there were 20,644 deaths from heart disease, ranking second among the top 10 causes of death [1]. The World Health Organization (WHO) has advocated nursing guidance with the concept of "empowerment", where patients can play an active and aggressive role in managing their health [2]. This paperless nursing health education guidance information can be designed through the application, which features non-professional expressions and visualization methods. The users can participate in feedback-based interactions and complete the questionnaires after receiving nursing guidance. This study used the Technology Acceptance Model (TAM) to evaluate patients' acceptance of the nursing guidance application and the effectiveness of such nursing guidance. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inclusion Criteria: * Heart failure Exclusion Criteria: * Health
Key inclusion criteria (1 listed)
- Heart failure
Key exclusion criteria (1 listed)
- Health
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApplicationKnowledge \& record | Device | The Development and Effectiveness of Heart Failure Self-Health Management Application |
Primary outcome
participant's knowledge about heart failure significantly increased after the intervention
Time frame: 6 months
Provides the data from the Dutch Heart Failure Knowledge Scale and Technology Acceptance Model. Analysis on participant's knowledge about heart failure and Technology Acceptance Model Scale after the Intervention. Higher scores mean a better outcome.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, 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 1 inclusion and 1 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: paused, as of the sponsor's last update on 2 May 2022. 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?
Results are not available in the source record.
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?
participant's knowledge about heart failure significantly increased after the intervention (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 May 2022.