Heart FailureNCT04327128
Selfcare MAnagement InteRvenTion in Heart Failure II (SMART HF II)
A study testing LifePod in people with Heart Failure, run by Lund University at 1 site in Sweden.
Trial summary
The purpose of the study is to evaluate if the digital support and communication platform for heart failure can provide patients with heart failure increased knowledge, compliance and quality of life and thus affect re-admissions and visit structure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- What is being tested?
- LifePod
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSweden
- Study dates
- 29 May 2019to 30 Apr 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed heart failure I.50 (newly discovered or existing) in NYHA Class I-IV in principle with ESC guidelines 2016.
- Have completed the "consent form" or consent form, see §4.2 Exclusion criteria: * Patient who refuses to participate in the trial.
- It is assessed that they can handle the intervention themselves or with the help of personal or relatives.
Who cannot join
- Patient who declines to participate in the trial.
- Impaired cognitive ability that is judged to affect the ability to conduct the study in the intended manner.
- Life expectancy <8 months
- In other ways, by the treating physician, it is deemed inappropriate to participate in the study, e.g. due to participation in another study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Digital Support and Communication Platform for Heart Failure:
The purpose of the study is to evaluate if the digital support and communication platform for heart failure can provide patients with heart failure increased knowledge, compliance and quality of life and thus affect re-admissions and visit structure.
To evaluate whether a digital support and communication platform for heart failure patients after 6 months can provide:
- Improved self-care
- Improved quality of life and reduced number of patient-assessed symptoms
- Reduction in the number of cardiovascular events, hospital nights, the number of hospitalizations or the number of deaths and out-patient visits
- Conditions
- Heart Failure
- Being tested
- LifePod
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifePodDevice
The intervention group is testing LifePod on a digital communication platform between patient and healthcare provider
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Standard heart failure care and a digital heart failure support system Receives: Device: LifePod |
| Control group | Other | Standard heart failure care Receives: Device: LifePod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-care behaviour
Improvement in self-care behaviour measured by the questionnaire European Heart Failure Self-care behaviour scale (EHFScB-9) A higher EHFScB-9 score indicates a worse self-care behaviour. The minimum score is 9 points and the maximum score is 45.
Measured: 6 month
Cardiovascular events and deaths
Number of participants with cardiovascular events and deaths during intervention and up to 12 months after inclusion
Measured: 12 month
Hospitalization and hospital days
Number of participants with new hospitalization and number of hospital days during intervention and up 12 months after inclusion
Measured: 12 months
Health care visits
Type and number of health care visits during intervention and up to 12 months after inclusion
Measured: 12 months
Patient-reported symptoms
Improved patient-reported symptoms as measured by questionnaire EuroQol three-dimensional questionnaire (EQ-5D-3L ) where high score represent worse symptoms. The minimum score is 7 points and the maximum score is 23 points.
Measured: 6 months
Quality of life
Improved quality of life as measured on visual analogue scale 0-100 where high figure represent best quality of life
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 posted30 Mar 2020
- Study start29 May 2019
- Primary completion31 Jan 2021
- Study completion30 Apr 2021
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 Lund UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sofia Gerward, Lund University
- Investigators
- Sofia Gerward, MD, PhD, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327128
- Sponsor's protocol ID
- SMART HF II, Dnr 20 19-00378
- Status last verified
- Jun 2021
- First submitted
- 15 Mar 2020
- Last updated
- 1 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Digital Support and Communication Platform for Heart Failure:
- ClinicalTrials.gov ID
- NCT04327128
- Acronym / sponsor ID
- SMART HF II, Dnr 20 19-00378
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 29 May 2019 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 30 Mar 2020 (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 the study is to evaluate if the digital support and communication platform for heart failure can provide patients with heart failure increased knowledge, compliance and quality of life and thus affect re-admissions and visit structure.
To evaluate whether a digital support and communication platform for heart failure patients after 6 months can provide:
- Improved self-care
- Improved quality of life and reduced number of patient-assessed symptoms
- Reduction in the number of cardiovascular events, hospital nights, the number of hospitalizations or the number of deaths and out-patient visits
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Device: LifePodStandard heart failure care and a digital heart failure support system |
| Control group | Other | Device: LifePodStandard heart failure care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed heart failure I.50 (newly discovered or existing) in NYHA Class I-IV in principle with ESC guidelines 2016.
Key exclusion criteria (4 listed)
- Patient who declines to participate in the trial.
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 |
|---|---|---|
| LifePodThe intervention group is testing LifePod on a digital communication platform between patient and healthcare provider | Device | Control group, Intervention group |
Primary outcome
Self-care behaviour
Time frame: 6 month
Improvement in self-care behaviour measured by the questionnaire European Heart Failure Self-care behaviour scale (EHFScB-9) A higher EHFScB-9 score indicates a worse self-care behaviour. The minimum score is 9 points and the maximum score is 45.
Cardiovascular events and deaths
Time frame: 12 month
Number of participants with cardiovascular events and deaths during intervention and up to 12 months after inclusion
Hospitalization and hospital days
Time frame: 12 months
Number of participants with new hospitalization and number of hospital days during intervention and up 12 months after inclusion
Health care visits
Time frame: 12 months
Type and number of health care visits during intervention and up to 12 months after inclusion
Patient-reported symptoms
Time frame: 6 months
Improved patient-reported symptoms as measured by questionnaire EuroQol three-dimensional questionnaire (EQ-5D-3L ) where high score represent worse symptoms. The minimum score is 7 points and the maximum score is 23 points.
Quality of life
Time frame: 6 months
Improved quality of life as measured on visual analogue scale 0-100 where high figure represent best quality of life
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 1 Jul 2021.
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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.
Sofia Gerward, MD, PhD principal investigator
Lund 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 LifePod in people with Heart Failure, run by Lund University at 1 site in Sweden.
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 3 inclusion and 4 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 1 Jul 2021. 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 Sweden. 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?
Self-care behaviour (time frame: 6 month). The study lists 6 primary outcomes in all. 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 1 Jul 2021.