Heart at Home- a Self-care Study

NCT01759368 | Completed Results

• 1 other identifier: HUSHAH
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of HF-related Hospital Days

  Number of heart failure related hospital days

  From baseline until the end of the study at six months

Secondary Outcomes (6)

• Death

  From baseline until the end of the study at six months

• Heart Transplant

  From baseline until the end of the study at six months

• P-proBNP

  From baseline until the end of the study at six months

• EHFSBS (European Heart Failure Self-Care Behaviour Scale ) Scores

  From baseline until the end of the study at six months

• Left Ventricular Ejection Fraction

  From baseline until the end of the study at six months

Other Outcomes (1)

• 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

Study Arms (2)

Telemonitoring assisted self-care

ACTIVE COMPARATOR

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.

Device: Telemonitoring assisted self-care

Control group

NO INTERVENTION

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

Interventions

Telemonitoring assisted self-care DEVICE

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

Telemonitoring assisted self-care

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VTT Technical Research Centre of Finland: lead
• Helsinki University Central Hospital: collaborator

Study Sites (1)

VTT Technical Research Centre of Finland

Espoo, Finland

Location

Related Publications (1)

• 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.

  PMID: 25498992 DERIVED

MeSH Terms

Conditions

Heart Failure; Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Anna-Leena Orsama
• Organization: VTT Technical Research Centre of Finland

anna-leena.orsama@vtt.fi

+358408485966

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2012
• First Posted: January 3, 2013
• Study Start: October 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: June 1, 2012
• Last Updated: September 17, 2014
• Results First Posted: September 17, 2014

Record last verified: 2014-09

Locations

FI (1)