Clinical trial NCT03655496: Patient-centred Home-based Management of Heart Failure
Official title: Patient-centred Home-based Management of Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Heart Failure
Keywords: patient centred
m-health
e-health
home-based
self-care
Lead sponsor: CareLigo AB
Sponsor class: INDUSTRY
Collaborators: name: Karolinska University Hospital
name: Danderyd's hospital
name: Stockholm South General Hospital
First posted: 2018-08-31
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled parallel trial
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Self-care behaviour
timeFrame: 6 months
Secondary outcomes:
measure: In-hospital days due to heart failure
timeFrame: 6 months
measure: Quality of life (general)
timeFrame: 6 months
measure: Quality of life (disease-specific)
timeFrame: 6 months
measure: Knowledge about heart failure
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Karolinska University Hospital
name: Inger Hagerman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Melin 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.
citation: Hovland-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.