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Heart at Home- a Self-care Study

This study has been completed.
Sponsor:
Collaborator:
Helsinki University Central Hospital
Information provided by (Responsible Party):
VTT Technical Research Centre of Finland
ClinicalTrials.gov Identifier:
NCT01759368
First received: December 20, 2012
Last updated: December 30, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Heart Failure
 Device: Telemonitoring assisted self-care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Heart at Home- Remote Patient Monitoring in the Care of Heart Failure Patients

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by VTT Technical Research Centre of Finland:

Primary Outcome Measures:
  • Number of hospital days [ Time Frame: study period of seven months on average ] [ Designated as safety issue: No ]
    Number of hospital days at the Cardiology Clinic.


Secondary Outcome Measures:
  • Death [ Time Frame: Study period of seven months on average ] [ Designated as safety issue: No ]
    Death from any cause

  • Heart transplant [ Time Frame: Study period of seven months on average ] [ Designated as safety issue: No ]
    Heart transplant operation or listing for transplant operation

  • P-proBNP [ Time Frame: Study period of seven months on average ] [ Designated as safety issue: No ]
    Change in plasma concentration of brain natriuretic peptide propeptide from baseline to seven months.

  • EHFSBS (European Heart Failure Self-Care Behaviour Scale ) scores [ Time Frame: Study period of seven months on average ] [ Designated as safety issue: No ]
    Change from baseline to seven months in self-care behaviour measured by the European Heart Failure Self-Care Behaviour Scale


Other Outcome Measures:
  • laboratory test [ Time Frame: Study period of seven months on average ] [ Designated as safety issue: No ]
    Change in plasma concentrations of creatinine, natrium, and potassium from the baseline to seven months.

  • left ventricular ejection fraction [ Time Frame: Study period of seven months on average ] [ Designated as safety issue: No ]
    Change in left ventricular ejection fraction from baseline to seven months.

  • Utilization of health care resources [ Time Frame: Study period of seven months on average ] [ Designated as safety issue: No ]
    number of visits at physician, number of visits at nurse, phone contacts with nurse, unplanned visits at nurse, unplanned visits at physician


Enrollment: 94
Study Start Date: October 2010
Study Completion Date: June 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Telemonitoring assisted self-care
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.
 Device: 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.
No Intervention: Control group
Control group received usual care

  Eligibility

Ages Eligible for Study:   18 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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, had severe comorbidity,, had participated in other clinical trial during last three months or were suspected of poor compliance were excluded in the study

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01759368

Locations
Finland
VTT Technical Research Centre of Finland
Espoo, Finland
Sponsors and Collaborators
VTT Technical Research Centre of Finland
Helsinki University Central Hospital
  More Information

No publications provided

Responsible Party: VTT Technical Research Centre of Finland
ClinicalTrials.gov Identifier: NCT01759368     History of Changes
Other Study ID Numbers: HUSHAH
Study First Received: December 20, 2012
Last Updated: December 30, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by VTT Technical Research Centre of Finland:
self-care, heart failure, telemonitoring, health care utilization

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013