Integrated Cardiac Care and Palliative Homecare for Patients With Severe Heart Failure
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|ClinicalTrials.gov Identifier: NCT01304381|
Recruitment Status : Completed
First Posted : February 25, 2011
Last Update Posted : June 18, 2013
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;
- 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 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 or disease||Intervention/treatment||Phase|
|Chronic Heart Failure||Other: Integrated care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Integrated Cardiac Care and Palliative Homecare for Patients With Severe Heart Failure|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
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
- 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 ]
- 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 ]
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): NCT01304381
|Skellefteå, Västerbotten, Sweden, 93186|