search
Back to results

Heart at Home- a Self-care Study

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Telemonitoring assisted self-care
Sponsored by
VTT Technical Research Centre of Finland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring self-care, heart failure, telemonitoring, health care utilization

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • VTT Technical Research Centre of Finland

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Telemonitoring assisted self-care

Control group

Arm 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.

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

Outcomes

Primary Outcome Measures

Number of HF-related Hospital Days
Number of heart failure related hospital days

Secondary Outcome Measures

Death
Death from any cause
Heart Transplant
Heart transplant operation or listing for transplant operation
P-proBNP
Change in plasma concentration of brain natriuretic peptide propeptide from baseline to the end of the study.
EHFSBS (European Heart Failure Self-Care Behaviour Scale ) Scores
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.
Left Ventricular Ejection Fraction
Change in left ventricular ejection fraction from baseline until the end of the study
Utilization of Health Care Resources
Number of visits to nurse's reception

Full Information

First Posted
December 20, 2012
Last Updated
September 15, 2014
Sponsor
VTT Technical Research Centre of Finland
Collaborators
Helsinki University Central Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01759368
Brief Title
Heart at Home- a Self-care Study
Official Title
Heart at Home- Remote Patient Monitoring in the Care of Heart Failure Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VTT Technical Research Centre of Finland
Collaborators
Helsinki University Central Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
self-care, heart failure, telemonitoring, health care utilization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telemonitoring assisted self-care
Arm Type
Active Comparator
Arm 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.
Arm Title
Control group
Arm Type
No Intervention
Arm 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
Intervention Type
Device
Intervention Name(s)
Telemonitoring assisted self-care
Intervention 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
Primary Outcome Measure Information:
Title
Number of HF-related Hospital Days
Description
Number of heart failure related hospital days
Time Frame
From baseline until the end of the study at six months
Secondary Outcome Measure Information:
Title
Death
Description
Death from any cause
Time Frame
From baseline until the end of the study at six months
Title
Heart Transplant
Description
Heart transplant operation or listing for transplant operation
Time Frame
From baseline until the end of the study at six months
Title
P-proBNP
Description
Change in plasma concentration of brain natriuretic peptide propeptide from baseline to the end of the study.
Time Frame
From baseline until the end of the study at six months
Title
EHFSBS (European Heart Failure Self-Care Behaviour Scale ) Scores
Description
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.
Time Frame
From baseline until the end of the study at six months
Title
Left Ventricular Ejection Fraction
Description
Change in left ventricular ejection fraction from baseline until the end of the study
Time Frame
From baseline until the end of the study at six months
Title
Utilization of Health Care Resources
Description
Number of visits to nurse's reception
Time Frame
From baseline until the end of the study at six months
Other Pre-specified Outcome Measures:
Title
Plasma Concentrations of Creatinine, Natrium, and Potassium From the Baseline to the End of the Study
Description
Change in plasma concentrations of creatinine, natrium, and potassium
Time Frame
From baseline to the end of the study at six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
VTT Technical Research Centre of Finland
City
Espoo
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
25498992
Citation
Vuorinen AL, Leppanen J, Kaijanranta H, Kulju M, Helio T, van Gils M, Lahteenmaki J. Use of home telemonitoring to support multidisciplinary care of heart failure patients in Finland: randomized controlled trial. J Med Internet Res. 2014 Dec 11;16(12):e282. doi: 10.2196/jmir.3651.
Results Reference
derived

Learn more about this trial

Heart at Home- a Self-care Study

We'll reach out to this number within 24 hrs