Trial Outcomes & Findings for Heart at Home- a Self-care Study (NCT NCT01759368)

NCT ID: NCT01759368

Last Updated: 2014-09-17

Results Overview

Number of heart failure related hospital days

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 94 participants
• Primary outcome timeframe: From baseline until the end of the study at six months
• Results posted on: 2014-09-17

Participant Flow

Participant milestones

Measure	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 make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring.	Control Group Control group received multidisciplinary care that was standard.
Overall Study STARTED	47	47
Overall Study COMPLETED	46	47
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	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 make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring.	Control Group Control group received multidisciplinary care that was standard.
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Heart at Home- a Self-care Study

Baseline characteristics by cohort

Measure	Telemonitoring-assisted Self-care n=47 Participants 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	Control Group n=47 Participants 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.	Total n=94 Participants Total of all reporting groups
Age, Continuous	57.9 years STANDARD_DEVIATION 11.9 • n=93 Participants	58.3 years STANDARD_DEVIATION 11.6 • n=4 Participants	58.0 years STANDARD_DEVIATION 11.7 • n=27 Participants
Sex: Female, Male Female	8 Participants n=93 Participants	8 Participants n=4 Participants	16 Participants n=27 Participants
Sex: Female, Male Male	39 Participants n=93 Participants	39 Participants n=4 Participants	78 Participants n=27 Participants
left ventricular ejection fraction	27.3 percentage STANDARD_DEVIATION 4.9 • n=93 Participants	28.6 percentage STANDARD_DEVIATION 5.0 • n=4 Participants	28.0 percentage STANDARD_DEVIATION 5.0 • n=27 Participants
NYHA ( Functional Classification of the New York Heart Association) 'Slight limitations in physical activity class II'	19 participants n=93 Participants	17 participants n=4 Participants	36 participants n=27 Participants
NYHA ( Functional Classification of the New York Heart Association) 'Marked limitation in physical activity class III	27 participants n=93 Participants	28 participants n=4 Participants	55 participants n=27 Participants
NYHA ( Functional Classification of the New York Heart Association) 'Severe limitations in physical activity class IV	1 participants n=93 Participants	2 participants n=4 Participants	3 participants n=27 Participants
Body mass index	28.4 kg/m2 STANDARD_DEVIATION 6.0 • n=93 Participants	27.9 kg/m2 STANDARD_DEVIATION 4.0 • n=4 Participants	28.2 kg/m2 STANDARD_DEVIATION 5.4 • n=27 Participants
Smoking Smoker	35 participants n=93 Participants	42 participants n=4 Participants	77 participants n=27 Participants
Smoking Non-smoker	12 participants n=93 Participants	5 participants n=4 Participants	17 participants n=27 Participants
Systolic blood pressure	112 mmHg STANDARD_DEVIATION 13 • n=93 Participants	116 mmHg STANDARD_DEVIATION 16 • n=4 Participants	114 mmHg STANDARD_DEVIATION 15 • n=27 Participants
Diastolic blood pressure	71 mmHg STANDARD_DEVIATION 10 • n=93 Participants	72 mmHg STANDARD_DEVIATION 10 • n=4 Participants	72 mmHg STANDARD_DEVIATION 10 • n=27 Participants
NT-proBNP	2347 ng/l n=93 Participants	1338 ng/l n=4 Participants	1700 ng/l n=27 Participants

PRIMARY outcome

Timeframe: From baseline until the end of the study at six months

Number of heart failure related hospital days

Outcome measures

Measure	Telemonitoring Assisted Self-care n=46 Participants Telemonitoring assisted self-care group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. A pre-installed software application in the mobile phone supported uploading of measurements and self-assessment of symptoms. The patients were advised to carry out and report the measurements together with the self-assessment once a week. Telemonitoring assisted self-care: 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.	Control Group n=47 Participants Control group received usual care
Number of HF-related Hospital Days	0.7 number of days Standard Deviation 2.4	1.4 number of days Standard Deviation 3.5

SECONDARY outcome

Timeframe: From baseline until the end of the study at six months

Death from any cause

Outcome measures

Measure	Telemonitoring Assisted Self-care n=46 Participants Telemonitoring assisted self-care group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. A pre-installed software application in the mobile phone supported uploading of measurements and self-assessment of symptoms. The patients were advised to carry out and report the measurements together with the self-assessment once a week. Telemonitoring assisted self-care: 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.	Control Group n=47 Participants Control group received usual care
Death	0 participants	0 participants

SECONDARY outcome

Timeframe: From baseline until the end of the study at six months

Heart transplant operation or listing for transplant operation

Outcome measures

Measure	Telemonitoring Assisted Self-care n=46 Participants Telemonitoring assisted self-care group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. A pre-installed software application in the mobile phone supported uploading of measurements and self-assessment of symptoms. The patients were advised to carry out and report the measurements together with the self-assessment once a week. Telemonitoring assisted self-care: 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.	Control Group n=47 Participants Control group received usual care
Heart Transplant	0 participants	0 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Telemonitoring Assisted Self-care n=46 Participants Telemonitoring assisted self-care group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. A pre-installed software application in the mobile phone supported uploading of measurements and self-assessment of symptoms. The patients were advised to carry out and report the measurements together with the self-assessment once a week. Telemonitoring assisted self-care: 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.	Control Group n=47 Participants Control group received usual care
P-proBNP	-198 ng/l Interval -1921.0 to 170.0	-50 ng/l Interval -831.0 to 260.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Telemonitoring Assisted Self-care n=46 Participants Telemonitoring assisted self-care group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. A pre-installed software application in the mobile phone supported uploading of measurements and self-assessment of symptoms. The patients were advised to carry out and report the measurements together with the self-assessment once a week. Telemonitoring assisted self-care: 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.	Control Group n=47 Participants Control group received usual care
EHFSBS (European Heart Failure Self-Care Behaviour Scale ) Scores	-5.0 Scores on a scale Interval -7.3 to -3.0	-3.8 Scores on a scale Interval -5.4 to -2.1

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Telemonitoring Assisted Self-care n=46 Participants Telemonitoring assisted self-care group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. A pre-installed software application in the mobile phone supported uploading of measurements and self-assessment of symptoms. The patients were advised to carry out and report the measurements together with the self-assessment once a week. Telemonitoring assisted self-care: 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.	Control Group n=47 Participants Control group received usual care
Left Ventricular Ejection Fraction	5.0 percentage unit Interval 1.8 to 8.1	4.2 percentage unit Interval 1.8 to 6.5

SECONDARY outcome

Timeframe: From baseline until the end of the study at six months

Number of visits to nurse's reception

Outcome measures

Measure	Telemonitoring Assisted Self-care n=46 Participants Telemonitoring assisted self-care group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. A pre-installed software application in the mobile phone supported uploading of measurements and self-assessment of symptoms. The patients were advised to carry out and report the measurements together with the self-assessment once a week. Telemonitoring assisted self-care: 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.	Control Group n=47 Participants Control group received usual care
Utilization of Health Care Resources	4.5 number of visits Standard Deviation 2.2	2.7 number of visits Standard Deviation 1.0

OTHER_PRE_SPECIFIED outcome

Timeframe: From baseline to the end of the study at six months

Change in plasma concentrations of creatinine, natrium, and potassium

Outcome measures

Outcome data not reported

Adverse Events

Telemonitoring Assisted Self-care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anna-Leena Orsama

VTT Technical Research Centre of Finland

Phone: +358408485966

Email: anna-leena.orsama@vtt.fi

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place