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
  Purpose

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.

Condition Intervention
Chronic Heart Failure
Other: Integrated care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Integrated Cardiac Care and Palliative Homecare for Patients With Severe Heart Failure

Resource links provided by NLM:


Further study details as provided by Umeå University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 72
Study Start Date: January 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.
No Intervention: control
Usual care is performed for the control group

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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. -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01304381

Locations
Sweden
Skellefteå hospital
Skellefteå, Västerbotten, Sweden, 93186
Sponsors and Collaborators
Umeå University
the Swedish Association of Local Authorities and Regions (SALAR)
  More Information

No publications provided by Umeå University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Margareta Brännström, Senior lecturer, Umeå University
ClinicalTrials.gov Identifier: NCT01304381     History of Changes
Other Study ID Numbers: HOPE001
Study First Received: February 24, 2011
Last Updated: June 16, 2013
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Umeå University:
Heart failure
Palliative care
Integrated care

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 29, 2014