Heart at Home- a Self-care Study

VTT Technical Research Centre of Finland

Status: Completed

Conditions: Heart Failure

Treatments: Device: Telemonitoring assisted self-care

Study type: Interventional

Funder types: Other

Identifiers

NCT01759368

HUSHAH

Details and patient eligibility

About

In the study benefits of using mobile phone assisted remote patient monitoring including self-measurements of blood pressure, heart rate and weight as well as monitoring of personal health status are investigated in the care of heart failure patients.

Enrollment: 94 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of systolic heart failure
• NYHA (New York Heart Association) classification > 1
• left ventricular ejection fraction ≤ 35%
• need for a regular control visit
• time from the last visit no longer than 6 months

Exclusion criteria

• Patients who were known to enter a major medical operation
• severe comorbidity,
• participation in other clinical trial during last three months-
• poor compliance in terms of familiarity with mobile phone

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

Telemonitoring assisted self-care

Active Comparator group

Description:

Telemonitoring group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. The measurements taken at home to be uploaded were: diastolic and systolic blood pressure, pulse, body weight and an assessment of symptoms. The symptom assessment concerned the patient's feelings of dizziness, dyspnea, palpitation, weakness and, oedema. Patients were also asked to evaluate their overall condition- whether their condition had deteriorated, improved or remained unchanged. The patients were advised to carry out and report the measurements together with the self-assessment once a week. The responsible nurse followed patients' status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring.

Treatment:

Device: Telemonitoring assisted self-care

Control group

No Intervention group

Description:

Control group received usual care that includes multidisciplinary care approach in which patients receive guidance and support for self-care. In the care of heart failure (HF) patients, the cardiac team plays a central role in monitoring and interpreting patient symptoms, optimizing medication and providing education. The cardiac team consists of two physicians, one specialized heart failure nurse and a physiotherapist who helps after a hospitalization period. As part of the care process, patients capable of carrying out self-care are identified and they are encouraged to regularly measure their blood pressure, heart rate and weight at home. So far, the information exchange between heart failure patients and care personnel has taken place during patients' visits to the clinic and by telephone. Systematic collection and exploitation of the self-measurement data has been difficult, since it depends on the patient's own activity