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Rehabilitative Care to Patients With Heart Failure

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2010 by University College Sjælland.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01239667
First Posted: November 11, 2010
Last Update Posted: November 11, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Aarhus
Information provided by:
University College Sjælland
  Purpose

Hypothesis and objectives of the study Systematic preparation of rehabilitation plan for rehabilitation in Phase III based on identification of self-care behavior patients with heart failure in NYHA class II and III, leading to patients' self-care behaviors strengthened, which will result in increased health status and ADL level 6 months after discharge from hospital with heart failure .

Target

  1. To develop evidence-based clinical guidelines for patient rehabilitation phase III
  2. To test the effect of individual rehabilitation plans based on clinical guidelines for patient rehabilitation in Phase III. Efficacy evaluated in relation to changes in self-care behaviors, health status and ADL function.

Material and Methods:

Controlled longitudinal study. Each intervention patient receives before the end of hospital rehabilitation designed a specific rehabilitation plan also contacted the patient by specially trained nurse telephone 4 and 12 weeks after completion of their rehabilitation in hospital and the patient has the opportunity to contact the department when needed. The effect of rehabilitation assessed by sending questionnaires SF 36 and EHFScB Scale 9, to assess patients' ADL functioning, self-care behaviors and self-rated health.

All patients participating in the planned rehabilitation in hospitals, so that the baseline is the end of Phase II. Intervention based on an analysis of the individual's need for continued rehabilitation (self care behavior, health status, ADL function) and the patient's perception of own situation. Draw up a plan and program together with the patient


Condition Intervention
Rehabilitation After Heart Failure Other: Individual oriented planning of the rehabilitation program for patients with heart failure

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Rehabilitative Care to Patients With Heart Failure

Resource links provided by NLM:


Further study details as provided by University College Sjælland:

Primary Outcome Measures:
  • Health related quality of life [ Time Frame: Measured 6 month after discharge from hospital ]
    Evidence for health related quality of life in heart failure patients in the rehabilitation phase, measured with instrument SF 36

  • Self Care Behavior [ Time Frame: measured 6 month after discharge ]
    Mesure the patients self care behavior by using the instrument European Heart Failure Self Care Behavior Scale

  • Activities of Daily Living [ Time Frame: 6 month after discharge ]
    measure the patients PADL and IADL functions


Estimated Enrollment: 194
Study Start Date: September 2010
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Life style counseling
Individual oriented rehabilitation plan in collaboration with the patient followed by measuring health related quality of life and self care behavior
Other: Individual oriented planning of the rehabilitation program for patients with heart failure
Individual oriented rehabilitation plan in collaboration with the patient followed by measuring health related quality of life and self care behavior

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:Patients who are 18 years or older and valued at NYHA II and III are included in the study. -

Exclusion Criteria:

  • Patients who do not wish to participate. Patients with language and communication impedes Sufficient participation. Patients who do not understand information, as well as patients diagnosed with neurological deficits.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01239667


Contacts
Contact: Palle Larsen, MSN and ph,.d student +4572481278 pla@ucsj.dk

Locations
Denmark
University of Aarhus Denmark Recruiting
Aarhus, Denmark, 8000
Contact: Preben Petersen, Lecturer Ph.d       pup53@post.cybercity.dk   
Principal Investigator: Palle Larsen, MSn ,ph.d stud         
Sponsors and Collaborators
University College Sjælland
University of Aarhus
Investigators
Principal Investigator: Palle Larsen, MSN and Ph.d. student Univcersity College Sjaelland
  More Information

Responsible Party: Johny Lauritsen, University College Sjaelland
ClinicalTrials.gov Identifier: NCT01239667     History of Changes
Other Study ID Numbers: pla123
First Submitted: October 25, 2010
First Posted: November 11, 2010
Last Update Posted: November 11, 2010
Last Verified: October 2010

Keywords provided by University College Sjælland:
Health related quality of Life, Self Care behavior, activities of daily living

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases