NCT05355506

Brief 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.".

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 2, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2022

Completed
Last Updated

May 2, 2022

Status Verified

April 1, 2022

Enrollment Period

3.4 years

First QC Date

April 11, 2022

Last Update Submit

April 29, 2022

Conditions

Keywords

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Study Arms (1)

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.

Device: Application

Interventions

Knowledge \& record

The Development and Effectiveness of Heart Failure Self-Health Management Application

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inclusion Criteria: * Heart failure Exclusion Criteria: * Health

You may qualify if:

  • Heart failure

You may not qualify if:

  • Health

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pei-Hung Liao

Taipei County, Taiwan

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
8 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 11, 2022

First Posted

May 2, 2022

Study Start

July 1, 2019

Primary Completion

December 3, 2022

Study Completion

December 3, 2022

Last Updated

May 2, 2022

Record last verified: 2022-04

Locations