Heart FailurePhase 1PACEMAN-HFNCT03655496
Patient-centred Home-based Management of Heart Failure
A Phase 1 study testing Home-based tool in people with Heart Failure, run by CareLigo AB.
Trial summary
A novel home-based tool for self-management is to be evaluated for heart failure patients. The tool assists the patient with symptom monitoring, education and titration of diuretics. Patients who were recently hospitalized for heart failure will be randomized to receiving the tool or standard care for six months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Home-based tool
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- 22 Feb 2013to 18 Dec 2013
- Phase
- Phase 1
- 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
- admitted due to acute heart failure
- diagnosed heart failure according to European Society of Cardiology (ESC) guidelines 2012
- prescribed loop-diuretics
- Signed letter of consent
Who cannot join
- more than mild cognitive impairment
- pregnancy
- having attended nurse-led heart failure clinic the past 12 months, or referred to one following this current hospitalization
- life-expectancy of less than 6 months
About this study
A novel home-based tool for self-management is to be evaluated for heart failure patients. The tool assists the patient with symptom monitoring, education and titration of diuretics. Patients who were recently hospitalized for heart failure will be randomized to receiving the tool or standard care for six months. The primary end-point will be self-care behaviour, as measured with the validated instrument the European Heart failure self-care behaviour Scale 9-item questionnaire (Jaarsma et al). Secondary end-points are in-hospital days due to heart failure, quality of life (general and disease-specific) as measured by the SF-36 and KCCQ questionnaires, and finally knowledge about heart failure, assessed by the Dutch Heart Failure Knowledge Scale.
Read the detailed description
Patients who are admitted to the emergency unit for decompensated heart failure at the three largest clinics in Stockholm, Sweden, are screened for recruitment. For patients to be eligible for study participation, they shall be discharged from the hospital to the general practitioner without being referred to a nurse led heart failure clinic, which is considered the gold standard in terms of improving patients' self-care behaviour. At the point of discharge, patients are approached about study participation and those who accept will be provided study information and forced to provide a written consent to participate. Continuous sampling is employed. Baseline characteristics are noted, as well as baseline data collected for the following end-points: Self-care, using the European Heart Failure Self-care Behaviour Scale (EHFScB), general quality of life using the SF-36 questionnaire, disease-specific quality of life using the Kansas City Cardiomyopathy Questionnaire (KCCQ) and knowledge about heart failure using the Dutch Heart Failure Knowledge Scale (DHFKS). After this data is collected patients will be randomized, using sealed envelopes, to either receive standard care or receive the home-based tool that constitutes the intervention investigated. Within one week after discharge, the patients randomized to the intervention group will have he tool installed in their home.
The tool consists of a tablet computer locked to a specialized software, and a Bluetooth connected weight scale. Every day the patient is encouraged by the tablet computer to step up on the weight scale. The weight is wirelessly transferred to the tablet computer and today's dose of diuretics is shown on screen together with a short tip about how to improve living with heart failure. Every five days the patient assess their self-perceived symptoms, as prompted on the tablet computer. For every patient equipped with the tool, a patient-specific normal dose of diuretics, as well as a high dose is input in the tool at the point of randomization. If the weight increases by 2kg or more in 3 days or less, the high dose is recommended for two days, after which the effect on the weight is assessed. If the weight was decreased back to where it was prior to the rapid weight gain, the dose is returned to normal and if it is still elevated, the patient will be encouraged to call his/her health care provider at the number presented on the table computer. If the self-assessed symptoms deteriorate, the same type of warning will appear on screen, urging the patient to contact the health care provider. Both the intervention patients and the control patients will be given the same discharge information in writing, describing the most important parts of self-management for heart failure patients. The data collected at baseline will be collected again after 3 months and 6 months after randomization. After 6 months data about hospitalizations will be retrieved from the medical records and adjudicated as either heart failure-hospitalization or not. The adjudication will be done by the cardiologists participating in the study and as the focus of the study is in estimating the net/marginal incidence rate ratio of in-patient hospitalization, absorbing competing events (e.g. death) will be handled by censoring.
- Conditions
- Heart Failure
- Being tested
- Home-based tool
- Keywords
- patient centred, m-health, e-health, home-based, self-care
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based toolDevice
The tool consists of a tablet computer and a Bluetooth connected weight scale. The patient is encouraged to use the tool daily. The weight is titrates the dose of diuretics and a short tip about how to improve living with heart failure, this is presented on the screen. Every five days the patient assess their self-perceived symptoms on the tablet computer. If the weight increases by 2kg or more in 3 days or less, the high dose is recommended for two days, after which the effect on the weight is assessed. If the weight increased was reverted, the dose is returned to normal and if it is still elevated, an alert on the table computer. If the self-assessed symptoms deteriorate, the same type of alert will appear on screen, urging the patient to contact the health care provider.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Subject to standard care. |
| Intervention group | Experimental | Exposed to the home-based tool. Receives: Device: Home-based tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-care behaviour
Assessed by the validated instrument European Heart Failure Self-care Behaviour Scale. It measures how well the patient adheres to advice provided from the health care professional. It si made up of nine questions to which the patient answers between "completely agree" and "completely disagree", corresponding to a score of 1 or 5 respectively. The possible scores on the questionnaire range from 9 to 45, where 9 corresponds to the most desireable self-care behaviour and 45 to the least favourable.
Measured: 6 months
Secondary outcomes (4)
In-hospital days due to heart failure
Data retrieved from the medical records after the intervention period is completed. All hospitalizations analyzed and adjudicated as either heart failure related or not.
Measured: 6 months
Quality of life (general)
Assessed by the 36-item Short Form survey (SF-36). The instrument includes 8 multi-item scales plus a single-item scale to compare the patient's current health with that 1 year ago. The 8 domains are physical functioning, physical role, bodily pain, general health vitality, social functioning, role of emotional health and role of mental health. SF-36 also consists of two summary scores: mental and physical. The scores range from 0 to 100 and higher scores indicate better quality of life.
Measured: 6 months
Quality of life (disease-specific)
Assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ). KCCQ is a 23-item (15 questions), self-administrating,disease-specifi c instrument that quantifi es 6 domains (scales) and 2 summary scores of patients' health status. The 6 domains are physical limitations, symptom score, symptom change, self-effi cacy, social interference and QoL. The 2 summary scores are labelled: clinical summary scores and overall summary scores. All scale scores are transformed to 0 - 100 scale, in which a higher score indicates better health related quality of life (HRQoL).
Measured: 6 months
Knowledge about heart failure
Assessed by the Dutch Heart Failure Knowledge Scale (DHFKS), which consists of 15 multiple-choice items (0 - 15). It measures knowledge in HF in general, symptom recognition and treatment. Higher scores indicate more knowledge.
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 posted31 Aug 2018
- Study start22 Feb 2013
- Primary completion18 Dec 2013
- Study completion18 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled parallel trial
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- CareLigo AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Karolinska University Hospital, Danderyd's hospital, Stockholm South General Hospital
- Responsible party
- Sponsor
- Investigators
- Inger Hagerman, PhD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03655496
- Sponsor's protocol ID
- PACEMAN-HF
- Acronym
- PACEMAN-HF
- Status last verified
- Aug 2018
- First submitted
- 30 Aug 2018
- Last updated
- 4 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hagglund E, Lynga P, Frie F, Ullman B, Persson H, Melin M, Hagerman I. Patient-centred home-based management of heart failure. Findings from a randomised clinical trial evaluating a tablet computer for self-care, quality of life and effects on knowledge. Scand Cardiovasc J. 2015 Aug;49(4):193-9. doi: 10.3109/14017431.2015.1035319. Epub 2015 Jun 4.
PubMed 25968968Melin M, Hagglund E, Ullman B, Persson H, Hagerman I. Effects of a Tablet Computer on Self-care, Quality of Life, and Knowledge: A Randomized Clinical Trial. J Cardiovasc Nurs. 2018 Jul/Aug;33(4):336-343. doi: 10.1097/JCN.0000000000000462.
PubMed 29369123Hovland-Tanneryd A, Melin M, Hagglund E, Hagerman I, Persson HE. From randomised controlled trial to real world implementation of a novel home-based heart failure tool: pooled and comparative analyses of two clinical controlled trials. Open Heart. 2019 May 28;6(1):e000954. doi: 10.1136/openhrt-2018-000954. eCollection 2019.
PubMed 31217992
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-centred Home-based Management of Heart Failure
- ClinicalTrials.gov ID
- NCT03655496
- Acronym / sponsor ID
- PACEMAN-HF / PACEMAN-HF
- Conditions
- Heart Failure
- Keywords
- patient centred, m-health, e-health, home-based, self-care
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- CareLigo ABIndustry (pharma, biotech, devices)
- Collaborators
- Karolinska University Hospital, Danderyd's hospital, Stockholm South General Hospital
- Study start
- 22 Feb 2013 (actual)
- Primary completion
- 18 Dec 2013 (actual)
- Study completion
- 18 Dec 2013 (actual)
- First posted
- 31 Aug 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.
A novel home-based tool for self-management is to be evaluated for heart failure patients. The tool assists the patient with symptom monitoring, education and titration of diuretics. Patients who were recently hospitalized for heart failure will be randomized to receiving the tool or standard care for six months. The primary end-point will be self-care behaviour, as measured with the validated instrument the European Heart failure self-care behaviour Scale 9-item questionnaire (Jaarsma et al). Secondary end-points are in-hospital days due to heart failure, quality of life (general and disease-specific) as measured by the SF-36 and KCCQ questionnaires, and finally knowledge about heart failure, assessed by the Dutch Heart Failure Knowledge Scale.
Detailed description
Patients who are admitted to the emergency unit for decompensated heart failure at the three largest clinics in Stockholm, Sweden, are screened for recruitment. For patients to be eligible for study participation, they shall be discharged from the hospital to the general practitioner without being referred to a nurse led heart failure clinic, which is considered the gold standard in terms of improving patients' self-care behaviour. At the point of discharge, patients are approached about study participation and those who accept will be provided study information and forced to provide a written consent to participate. Continuous sampling is employed. Baseline characteristics are noted, as well as baseline data collected for the following end-points: Self-care, using the European Heart Failure Self-care Behaviour Scale (EHFScB), general quality of life using the SF-36 questionnaire, disease-specific quality of life using the Kansas City Cardiomyopathy Questionnaire (KCCQ) and knowledge about heart failure using the Dutch Heart Failure Knowledge Scale (DHFKS). After this data is collected patients will be randomized, using sealed envelopes, to either receive standard care or receive the home-based tool that constitutes the intervention investigated. Within one week after discharge, the patients randomized to the intervention group will have he tool installed in their home.
The tool consists of a tablet computer locked to a specialized software, and a Bluetooth connected weight scale. Every day the patient is encouraged by the tablet computer to step up on the weight scale. The weight is wirelessly transferred to the tablet computer and today's dose of diuretics is shown on screen together with a short tip about how to improve living with heart failure. Every five days the patient assess their self-perceived symptoms, as prompted on the tablet computer. For every patient equipped with the tool, a patient-specific normal dose of diuretics, as well as a high dose is input in the tool at the point of randomization. If the weight increases by 2kg or more in 3 days or less, the high dose is recommended for two days, after which the effect on the weight is assessed. If the weight was decreased back to where it was prior to the rapid weight gain, the dose is returned to normal and if it is still elevated, the patient will be encouraged to call his/her health care provider at the number presented on the table computer. If the self-assessed symptoms deteriorate, the same type of warning will appear on screen, urging the patient to contact the health care provider. Both the intervention patients and the control patients will be given the same discharge information in writing, describing the most important parts of self-management for heart failure patients. The data collected at baseline will be collected again after 3 months and 6 months after randomization. After 6 months data about hospitalizations will be retrieved from the medical records and adjudicated as either heart failure-hospitalization or not. The adjudication will be done by the cardiologists participating in the study and as the focus of the study is in estimating the net/marginal incidence rate ratio of in-patient hospitalization, absorbing competing events (e.g. death) will be handled by censoring.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled parallel trial
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Subject to standard care. |
| Intervention group | Experimental | Device: Home-based toolExposed to the home-based tool. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- admitted due to acute heart failure
- diagnosed heart failure according to European Society of Cardiology (ESC) guidelines 2012
- prescribed loop-diuretics
- Signed letter of consent
Key exclusion criteria (4 listed)
- more than mild cognitive impairment
- pregnancy
- having attended nurse-led heart failure clinic the past 12 months, or referred to one following this current hospitalization
- life-expectancy of less than 6 months
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 |
|---|---|---|
| Home-based toolThe tool consists of a tablet computer and a Bluetooth connected weight scale. The patient is encouraged to use the tool daily. The weight is titrates the dose of diuretics and a short tip about how to improve living with heart failure, this is presented on the screen. Every five days the patient assess their self-perceived symptoms on the tablet computer. If the weight increases by 2kg or more in 3 days or less, the high dose is recommended for two days, after which the effect on the weight is assessed. If the weight increased was reverted, the dose is returned to normal and if it is still elevated, an alert on the table computer. If the self-assessed symptoms deteriorate, the same type of alert will appear on screen, urging the patient to contact the health care provider. | Device | Intervention group |
Primary outcome
Self-care behaviour
Time frame: 6 months
Assessed by the validated instrument European Heart Failure Self-care Behaviour Scale. It measures how well the patient adheres to advice provided from the health care professional. It si made up of nine questions to which the patient answers between "completely agree" and "completely disagree", corresponding to a score of 1 or 5 respectively. The possible scores on the questionnaire range from 9 to 45, where 9 corresponds to the most desireable self-care behaviour and 45 to the least favourable.
4 secondary outcomes
In-hospital days due to heart failure
Time frame: 6 months
Quality of life (general)
Time frame: 6 months
Quality of life (disease-specific)
Time frame: 6 months
Knowledge about heart failure
Time frame: 6 months
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 4 Sep 2018.
- Background: PubMed 25968968Hagglund E, Lynga P, Frie F, Ullman B, Persson H, Melin M, Hagerman I. Patient-centred home-based management of heart failure. Findings from a randomised clinical trial evaluating a tablet computer for self-care, quality of life and effects on knowledge. Scand Cardiovasc J. 2015 Aug;49(4):193-9. doi: 10.3109/14017431.2015.1035319. Epub 2015 Jun 4.
- Background: PubMed 29369123Melin M, Hagglund E, Ullman B, Persson H, Hagerman I. Effects of a Tablet Computer on Self-care, Quality of Life, and Knowledge: A Randomized Clinical Trial. J Cardiovasc Nurs. 2018 Jul/Aug;33(4):336-343. doi: 10.1097/JCN.0000000000000462.
- Derived from this study: PubMed 31217992Hovland-Tanneryd A, Melin M, Hagglund E, Hagerman I, Persson HE. From randomised controlled trial to real world implementation of a novel home-based heart failure tool: pooled and comparative analyses of two clinical controlled trials. Open Heart. 2019 May 28;6(1):e000954. doi: 10.1136/openhrt-2018-000954. eCollection 2019.
- 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.
Inger Hagerman, PhD principal investigator
Karolinska University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Home-based tool in people with Heart Failure, run by CareLigo AB.
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 4 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 4 Sep 2018. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03655496, which also lists 3 linked publications.
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 4 Sep 2018.