Heart FailureHFSCNCT03194841
Heart Failure Self-care With the Aid of a Smartphone Application
A study testing Heart failure application in people with Heart Failure, run by University of Massachusetts, Worcester.
Trial summary
The purpose of this study was the development, and testing of a HF application that was used to provide self-care support to HF patients through a smartphone device. The study appraised current available literature on HF to determine best practices for promoting self-care of HF through direct communication with… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Heart failure application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 22 Aug 2016to 6 Jan 2017
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- living in a non-nursing home setting
- primary providers of own self-care
- established diagnosis of heart failure
- cognitively intact
- able to speak/write English
Who cannot join
- not willing to use a smartphone
- not exhibiting acute decompensated heart failure symptoms
About this study
The purpose of this study was the development, and testing of a HF application that was used to provide self-care support to HF patients through a smartphone device. The study appraised current available literature on HF to determine best practices for promoting self-care of HF through direct communication with individuals with HF living at home. For the purpose of this study, smart phone communication was utilized. Smart phone applications allow patients to transmit physiological data, such as weight, blood pressure, heart rate, and symptom data to healthcare providers. Using a secure website, a healthcare worker can access the information and contact the patient via the mobile phone when their data is out of normal range. This study was novel in its approach from what is traditionally offered in that it supported patient self-care decisions by promoting symptom monitoring and offered both tactical and situational skills strategies through at the point education.
- Conditions
- Heart Failure
- Being tested
- Heart failure application
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart failure applicationOther
A mobile phone application that allowed for input of physiologic data, qualitative question input and education retrieval along with SMS use.
| Study group | Role | What they receive |
|---|---|---|
| Heart Failure Application | Experimental | A mobile application that allowed for input of physiologic data, qualitative questions about symptoms and education Receives: Other: Heart failure application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Care of Heart Failure Index (SCHFI)
Measures how well a person monitors their symptoms, adhere to medication/diet and how confident they are in performing self-care.
Measured: two weeks
Secondary outcomes (1)
Heart Failure Somatic Awareness Scale
It determines the extent of distress associated with heart failure symptoms.
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start22 Aug 2016
- Primary completion6 Jan 2017
- Study completion6 Jan 2017
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.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marva Foster, University of Massachusetts, Worcester
- Investigators
- Kristen Sethares, PhD, Study chair, University of Massachusetts Dartmouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194841
- Sponsor's protocol ID
- 15.064
- Acronym
- HFSC
- Status last verified
- Jun 2017
- First submitted
- 16 Jun 2017
- Last updated
- 21 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Failure Self-care With the Aid of a Smartphone Application
- ClinicalTrials.gov ID
- NCT03194841
- Acronym / sponsor ID
- HFSC / 15.064
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- 22 Aug 2016 (actual)
- Primary completion
- 6 Jan 2017 (actual)
- Study completion
- 6 Jan 2017 (actual)
- First posted
- 21 Jun 2017 (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.
The purpose of this study was the development, and testing of a HF application that was used to provide self-care support to HF patients through a smartphone device. The study appraised current available literature on HF to determine best practices for promoting self-care of HF through direct communication with individuals with HF living at home. For the purpose of this study, smart phone communication was utilized. Smart phone applications allow patients to transmit physiological data, such as weight, blood pressure, heart rate, and symptom data to healthcare providers. Using a secure website, a healthcare worker can access the information and contact the patient via the mobile phone when their data is out of normal range. This study was novel in its approach from what is traditionally offered in that it supported patient self-care decisions by promoting symptom monitoring and offered both tactical and situational skills strategies through at the point education.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart Failure Application | Experimental | Other: Heart failure applicationA mobile application that allowed for input of physiologic data, qualitative questions about symptoms and education |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- living in a non-nursing home setting
- primary providers of own self-care
- established diagnosis of heart failure
- cognitively intact
- able to speak/write English
Key exclusion criteria (2 listed)
- not willing to use a smartphone
- not exhibiting acute decompensated heart failure symptoms
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 |
|---|---|---|
| Heart failure applicationA mobile phone application that allowed for input of physiologic data, qualitative question input and education retrieval along with SMS use. | Other | Heart Failure Application |
Primary outcome
Self-Care of Heart Failure Index (SCHFI)
Time frame: two weeks
Measures how well a person monitors their symptoms, adhere to medication/diet and how confident they are in performing self-care.
1 secondary outcome
Heart Failure Somatic Awareness Scale
Time frame: two 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 21 Jun 2017.
- Individual participant dataSharing planned: No
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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.
Kristen Sethares, PhD study chair
University of Massachusetts Dartmouth
Questions about this trial
What is this clinical trial studying?
A study testing Heart failure application in people with Heart Failure, run by University of Massachusetts, Worcester.
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 5 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 21 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Self-Care of Heart Failure Index (SCHFI) (time frame: two 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 21 Jun 2017.