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Integrated Cardiac Care and Palliative Homecare for Patients With Severe Heart Failure

This study has been completed.
Sponsor:
Collaborator:
the Swedish Association of Local Authorities and Regions (SALAR)
Information provided by (Responsible Party):
Margareta Brännström, Umeå University
ClinicalTrials.gov Identifier:
NCT01304381
First received: February 24, 2011
Last updated: June 16, 2013
Last verified: June 2013

February 24, 2011
June 16, 2013
January 2011
April 2013   (final data collection date for primary outcome measure)
changes from baseline values of symptom scores on the the Edmonton assessment scale (ESAS) after intervention of 4, 12 and 24 weeks [ Time Frame: baseline and after 4, 16 and 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01304381 on ClinicalTrials.gov Archive Site
changes from baseline value of quality of life scores on the EQ-5D and activities in daily life (ADL) after intervention of 4, 12 and 24 weeks [ Time Frame: baseline, after 4,16 and 24 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Integrated Cardiac Care and Palliative Homecare for Patients With Severe Heart Failure
Integrated Cardiac Care and Palliative Homecare for Patients With Severe Heart Failure

Patients with severe heart failure have as many symptoms as many patients with cancer but yet do not have equal access to supportive and palliative care. They have an unpredictable course of illness, which makes difficult to judge when the palliative stage has been reached. The Heart failure and Palliative care Programme is a three-year project in Sweden financed by the Swedish Association of Local Authorities and Regions (SALAR). The overall aim is to develop, implement and evaluate a model that integrates cardiac care and palliative advanced home care for patients with severe chronic heart failure. The primary aim is to study the effects on patients' symptom burden, quality of life and activities of daily living. A randomized controlled clinical study is planned.

Patients (n=62) with a confirmed diagnosis in accordance with the criteria proposed by the European Society of Cardiology and with NYHA III-IV symptoms and at least one of following criteria will be included;

  1. At least one episode of worsening heart failure that resolved with injection / infusion of diuretics or the addition of other heart failure treatment in the last 6 months and regarded optimally treated according to the responsible physician.
  2. Need for infusions-treatment.
  3. Chronic poor quality of life (VAS < 50)
  4. Signs of cardiac cachexia (involuntary non-oedematous weight loss ≥ 6% of total body weight within the last 6-12 months)
  5. less than one year life expectancy The participants will be randomized to intervention or control group. The intervention consist of a multidisciplinary approach and collaboration between specialist palliative and heart failure (HF) caregivers, in a shared structured person-centred and identity-promoting care at home during six months. Usual care is performed for the control group.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Chronic Heart Failure
  • Other: Integrated care
    Intervention Multidisciplinary approach and collaboration between specialist palliative and heart failure caregivers, in a shared structured person-centred and identity-promoting care during 6 months
  • Other: Integrated care
    One group with 31 participants is offered a multidisciplinary approach and collaboration between specialist palliative and heart failure caregivers in a shared structured person-centred care at home. Assessment of need, length of visits and phone calls are planned to be adapted for each patient. After 6 months (+ - two weeks) the patients will be transferred to usual care provider following an established individual care plan.
  • Experimental: Integrated care
    Multidisciplinary approach and collaboration between specialist palliative and heart failure (HF) caregivers in a shared structured person-centred and identity-promoting homecare
    Interventions:
    • Other: Integrated care
    • Other: Integrated care
  • No Intervention: control
    Usual care is performed for the control group
Brännström M, Boman K. A new model for integrated heart failure and palliative advanced homecare--rationale and design of a prospective randomized study. Eur J Cardiovasc Nurs. 2013 Jun;12(3):269-75. doi: 10.1177/1474515112445430. Epub 2012 May 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
April 2013
April 2013   (final data collection date for primary outcome measure)

Patients with a confirmed diagnosis in accordance with the criteria proposed by the European Society of Cardiology and with NYHA III-IV symptoms. And at least one of following criteria;

  1. At least one episode of worsening heart failure that resolved with injection / infusion of diuretics or the addition of other heart failure treatment in the last 6 months and regarded optimally treated according to the responsible physician.
  2. Need for infusions-treatment.
  3. Chronic poor quality of life (VAS < 50)
  4. Signs of cardiac cachexia (involuntary non-oedematous weight loss ≥ 6% of total body weight within the last 6-12 months)
  5. less than one year life expectancy.

Exclusion Criteria:

Ineligible are patients:

  1. who do not want to participate in the study;
  2. with severe communication problems;
  3. with severe dementia;
  4. with other serious disease in which heart failure is of secondary importance;
  5. with other life-threatening illness as the primary diagnosis with expected short survival;
  6. when the Primary Care Center which is responsible for patient care is geographically located from more than 30 km radius outside the hospital; and
  7. participating in another clinical trial. -
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01304381
HOPE001
Yes
Margareta Brännström, Umeå University
Umeå University
the Swedish Association of Local Authorities and Regions (SALAR)
Not Provided
Umeå University
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP