NCT01239667

Brief Summary

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. 1.To develop evidence-based clinical guidelines for patient rehabilitation phase III
  2. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
194

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2010

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 11, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

November 11, 2010

Status Verified

October 1, 2010

Enrollment Period

8 months

First QC Date

October 25, 2010

Last Update Submit

November 10, 2010

Conditions

Keywords

Health related quality of Life, Self Care behavior, activities of daily living

Outcome Measures

Primary Outcomes (3)

  • Health related quality of life

    Evidence for health related quality of life in heart failure patients in the rehabilitation phase, measured with instrument SF 36

    Measured 6 month after discharge from hospital

  • Self Care Behavior

    Mesure the patients self care behavior by using the instrument European Heart Failure Self Care Behavior Scale

    measured 6 month after discharge

  • Activities of Daily Living

    measure the patients PADL and IADL functions

    6 month after discharge

Study Arms (1)

Life style counseling

EXPERIMENTAL

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

Interventions

Individual oriented rehabilitation plan in collaboration with the patient followed by measuring health related quality of life and self care behavior

Life style counseling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Aarhus Denmark

Aarhus, Aarhus, 8000, Denmark

RECRUITING

Study Officials

  • Palle Larsen, MSN and Ph.d. student

    Univcersity College Sjaelland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Palle Larsen, MSN and ph,.d student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 25, 2010

First Posted

November 11, 2010

Study Start

September 1, 2010

Primary Completion

May 1, 2011

Study Completion

February 1, 2012

Last Updated

November 11, 2010

Record last verified: 2010-10

Locations