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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Skellefteå hospital

Skellefteå, Västerbotten County, 93186, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

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.
Need for infusions-treatment.
Chronic poor quality of life (VAS < 50)
Signs of cardiac cachexia (involuntary non-oedematous weight loss ≥ 6% of total body weight within the last 6-12 months)
less than one year life expectancy.

Exclusion criteria

Ineligible are patients:

who do not want to participate in the study;
with severe communication problems;
with severe dementia;
with other serious disease in which heart failure is of secondary importance;
with other life-threatening illness as the primary diagnosis with expected short survival;
when the Primary Care Center which is responsible for patient care is geographically located from more than 30 km radius outside the hospital; and
participating in another clinical trial. -

Treatment and study plan

Integrated care

Other

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

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

Swedish Association of Local Authorities and Regions

Registry information

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Feb 25, 2011
Registry last updated: Jun 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed