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

Not Applicable

Completed

• Conditions: Chronic Heart Failure
• Interventions: Other: Integrated care

• Registration Number: NCT01304381
• Lead Sponsor: Umeå University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-02-24
• Study First Submitted QC: 2011-02-24
• Study First Posted: 2011-02-25
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-16
• Last Update Posted: 2013-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Not provided

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. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Integrated care	Integrated care	Multidisciplinary approach and collaboration between specialist palliative and heart failure (HF) caregivers in a shared structured person-centred and identity-promoting homecare

Primary Outcome Measures

Name	Time	Method
changes from baseline values of symptom scores on the the Edmonton assessment scale (ESAS) after intervention of 4, 12 and 24 weeks	baseline and after 4, 16 and 24 weeks

Secondary Outcome Measures

Name	Time	Method
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	baseline, after 4,16 and 24 weeks

Trial Locations

Locations (1)

Skellefteå hospital; 🇸🇪 Skellefteå, Västerbotten, Sweden