Heart at Home- a Self-care Study

Heart at Home- Remote Patient Monitoring in the Care of Heart Failure Patients

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01759368

Enrollment

Registered

2013-01-03

Start date

2010-10-31

Completion date

2012-06-30

Last updated

2014-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

self-care, heart failure, telemonitoring, health care utilization

Brief summary

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.

Interventions

DEVICETelemonitoring assisted self-care

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Number of HF-related Hospital Days	From baseline until the end of the study at six months	Number of heart failure related hospital days

Secondary

Measure	Time frame	Description
Death	From baseline until the end of the study at six months	Death from any cause
Heart Transplant	From baseline until the end of the study at six months	Heart transplant operation or listing for transplant operation
P-proBNP	From baseline until the end of the study at six months	Change in plasma concentration of brain natriuretic peptide propeptide from baseline to the end of the study.
Left Ventricular Ejection Fraction	From baseline until the end of the study at six months	Change in left ventricular ejection fraction from baseline until the end of the study
Utilization of Health Care Resources	From baseline until the end of the study at six months	Number of visits to nurse's reception
EHFSBS (European Heart Failure Self-Care Behaviour Scale ) Scores	From baseline until the end of the study at six months	Change in self-care behaviour measured by the European Heart Failure Self-Care Behaviour Scale (EHFSBS). EHFSBS is a 12-item self-administered questionnaire specifically designed and tested for heart failure patients including statements on self-care behaviour essential in the care of HF. The statements are scored from one to five. The lower the score, the better the performance in self-care. The summary score is analysed.

Other

Measure	Time frame	Description
Plasma Concentrations of Creatinine, Natrium, and Potassium From the Baseline to the End of the Study	From baseline to the end of the study at six months	Change in plasma concentrations of creatinine, natrium, and potassium

Countries

Finland

Participant flow

Participants by arm

Arm	Count
Telemonitoring-assisted Self-care 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 mak	47
Control Group Control group received usual care that includes multidisciplinary care approach in which patients receive guidance and support for self-care. In the care of 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.	47
Total	94

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	1	0

Baseline characteristics

Characteristic	Telemonitoring-assisted Self-care	Control Group	Total
Age, Continuous	57.9 years STANDARD_DEVIATION 11.9	58.3 years STANDARD_DEVIATION 11.6	58.0 years STANDARD_DEVIATION 11.7
Body mass index	28.4 kg/m2 STANDARD_DEVIATION 6	27.9 kg/m2 STANDARD_DEVIATION 4	28.2 kg/m2 STANDARD_DEVIATION 5.4
Diastolic blood pressure	71 mmHg STANDARD_DEVIATION 10	72 mmHg STANDARD_DEVIATION 10	72 mmHg STANDARD_DEVIATION 10
left ventricular ejection fraction	27.3 percentage STANDARD_DEVIATION 4.9	28.6 percentage STANDARD_DEVIATION 5	28.0 percentage STANDARD_DEVIATION 5
NT-proBNP	2347 ng/l	1338 ng/l	1700 ng/l
NYHA ( Functional Classification of the New York Heart Association) 'Marked limitation in physical activity class III	27 participants	28 participants	55 participants
NYHA ( Functional Classification of the New York Heart Association) 'Severe limitations in physical activity class IV	1 participants	2 participants	3 participants
NYHA ( Functional Classification of the New York Heart Association) 'Slight limitations in physical activity class II'	19 participants	17 participants	36 participants
Sex: Female, Male Female	8 Participants	8 Participants	16 Participants
Sex: Female, Male Male	39 Participants	39 Participants	78 Participants
Smoking Non-smoker	12 participants	5 participants	17 participants
Smoking Smoker	35 participants	42 participants	77 participants
Systolic blood pressure	112 mmHg STANDARD_DEVIATION 13	116 mmHg STANDARD_DEVIATION 16	114 mmHg STANDARD_DEVIATION 15

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 46	0 / 47
serious Total, serious adverse events	0 / 46	0 / 47