Self-ManagementNCT03509506
A Self-care Mobile Health App in Individuals With Heart Failure
A study testing App Group in people with Self-Management and Mobile Applications, run by Texas Woman's University at 1 site in United States.
Trial summary
This study was designed to determine the potential benefits that individuals with heart failure (HF) could experience from using a mobile application. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Self-Management, Mobile Applications, Heart Failure
- What is being tested?
- App Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 5 Feb 2021
- 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
- Adults with chronic heart failure, class I - III based on New York Heart Association (NYHA) scale
- Walking independently with/without an assistive device
- Exclusion Criteria: The participant will be excluded if one or more of the following is present
- Cognitive impairment (< 26 on Montreal Cognitive Assessment).
- Uncorrected vision
- Hearing problems
Show all 9Show fewer
- Neurological disorders.
- Cannot speak and read the English language,
- Not owning a smart cell phone with internet access.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Usability and Effectiveness of a Self-care Mobile Health App in Individuals With Heart Failure
This study was designed to determine the potential benefits that individuals with heart failure (HF) could experience from using a mobile application.
Read the detailed description
The mobile application is called the Heart Failure Health Storylines (HFHS). The potential benefits will be examined by determining the changes in physical activity and quality of life of the participants, who will use the application and compare the results with the participants, who will not use the application.
- Conditions
- Self-Management, Mobile Applications, Heart Failure
- Being tested
- App Group
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App GroupBehavioural
The participants will be educated to use the HFHS application to monitor their daily vital signs (HR, BP, body weight), physical activity, and medications for 4 weeks.
The research team will monitor their data entry remotely via the HFHS App. The team will text the participant via the App if one or more of following conditions is noted:
- The vital signs show undesired readings
- The records on the HFHS App show that the participant did not take the medications as the schedule says
In addition, the team will call the participant 3 days later to follow up regarding the participant's action towards the text message that the team sent.
| Study group | Role | What they receive |
|---|---|---|
| Non-App Group | No intervention | The participants will be instructed to continue their daily routine, track their daily steps with a pedometer, and record their daily steps on the "Activity Log" paper form. |
| App Group | Experimental | The participants will be trained how to use the mobile application (Heart Failure Health Storyline (HFHS)) to track their health status, physical activity, manage their medications schedule, and explore the other features that the application has. Additionally, they will receive a pedometer to track their daily steps and record their data on the mobile application. Receives: Behavioral: App Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Experience
The Quality of Experience (QoE) survey will be used to measure the quality of experience in using the mobile application
Measured: Change from baseline to 4 weeks
Secondary outcomes (3)
Quality of Life for Individuals with Heart Failure
36-Item Short-Form Health Survey (SF-36 version 1.0)
Measured: Change from baseline to 4 weeks
Quality of Life for Individuals with HF
Minnesota Living with Heart Failure (MLHF) questionnaire
Measured: Change from baseline to 4 weeks
Physical Activity will be indicated by daily step counts
Physical activity will be assessed with a pedometer
Measured: Change from baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start1 May 2018
- Primary completion15 Jul 2020
- Study completion5 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-ManagementStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suh Jen Lin, PhD, PT, Principal investigator, Texas Woman's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509506
- Sponsor's protocol ID
- 19985
- Status last verified
- Apr 2022
- First submitted
- 9 Apr 2018
- Last updated
- 25 Apr 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 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability and Effectiveness of a Self-care Mobile Health App in Individuals With Heart Failure
- ClinicalTrials.gov ID
- NCT03509506
- Acronym / sponsor ID
- 19985
- Conditions
- Self-Management, Mobile Applications, Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Texas Woman's UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 5 Feb 2021 (actual)
- First posted
- 26 Apr 2018 (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.
This study was designed to determine the potential benefits that individuals with heart failure (HF) could experience from using a mobile application.
Detailed description
The mobile application is called the Heart Failure Health Storylines (HFHS). The potential benefits will be examined by determining the changes in physical activity and quality of life of the participants, who will use the application and compare the results with the participants, who will not use the application.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-App Group | No intervention | –The participants will be instructed to continue their daily routine, track their daily steps with a pedometer, and record their daily steps on the "Activity Log" paper form. |
| App Group | Experimental | Behavioral: App GroupThe participants will be trained how to use the mobile application (Heart Failure Health Storyline (HFHS)) to track their health status, physical activity, manage their medications schedule, and explore the other features that the application has. Additionally, they will receive a pedometer to track their daily steps and record their data on the mobile application. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults with chronic heart failure, class I - III based on New York Heart Association (NYHA) scale
- Walking independently with/without an assistive device
- Exclusion Criteria: The participant will be excluded if one or more of the following is present
- Cognitive impairment (< 26 on Montreal Cognitive Assessment).
- Uncorrected vision
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| App GroupThe participants will be educated to use the HFHS application to monitor their daily vital signs (HR, BP, body weight), physical activity, and medications for 4 weeks. The research team will monitor their data entry remotely via the HFHS App. The team will text the participant via the App if one or more of following conditions is noted: * The vital signs show undesired readings * The records on the HFHS App show that the participant did not take the medications as the schedule says In addition, the team will call the participant 3 days later to follow up regarding the participant's action towards the text message that the team sent. | Behavioural | App Group |
Primary outcome
Quality of Experience
Time frame: Change from baseline to 4 weeks
The Quality of Experience (QoE) survey will be used to measure the quality of experience in using the mobile application
3 secondary outcomes
Quality of Life for Individuals with Heart Failure
Time frame: Change from baseline to 4 weeks
Quality of Life for Individuals with HF
Time frame: Change from baseline to 4 weeks
Physical Activity will be indicated by daily step counts
Time frame: Change from baseline to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
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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.
Suh Jen Lin, PhD, PT principal investigator
Texas Woman's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App Group in people with Self-Management and Mobile Applications, run by Texas Woman's University at 1 site in United States.
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 9 inclusion and 0 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 25 Apr 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 United States. 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?
Quality of Experience (time frame: Change from baseline to 4 weeks). 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 25 Apr 2022.