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

Chronic Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01304381
• Other study ID #: HOPE001
• Status: Completed
• Phase: N/A
• First received: February 24, 2011
• Last updated: June 16, 2013
• Start date: January 2011
• Est. completion date: April 2013

Study information

• Verified date: June 2013
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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. -

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

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
• 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.

Locations

Country	Name	City	State
Sweden	Skellefteå hospital	Skellefteå	Västerbotten

Sponsors (2)

Lead Sponsor	Collaborator
Umeå University	Swedish Association of Local Authorities and Regions

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Brännström M, Brulin C, Norberg A, Boman K, Strandberg G (2005). Being a palliative nurse for persons with severe congestive heart failure in advanced homecare. European Journal of Cardiovascular Nursing, 2005;4 (4):314-323. Brännström M, Ekman I, Norberg A, Boman K, Strandberg G. Living with severe chronic heart failure in palliative advanced home care. European Journal of Cardiovascular Nursing, 2006;5(4):295-302. Brännström M, Ekman I, Boman K, Strandberg G. Being a close relative of a person with severe chronic heart failure in palliative advanced home care - a comfort but also a strain. Scandinavian Journal of Caring Sciences, 2007;21(3):338-344 . Brännström M, Ekman I, Boman K, Strandberg G. Narratives of a man with severe chronic heart failure and his wife in palliative advanced home care over a 4.5-year period. Contemporary Nurse, 2007;27(2):10-22. Brännström M, Björck M, Strandberg G, Wanhainen A. Patients' experiences of being informed about having an abdominal aortic aneurysm - A follow-up case study five years after screening. Journal of Vascular Nursing, 2009;27(3):70-4. Lundman B, Brännström M, Hägglund L, Strandberg G. Fatigue in elderly with chronic heart failure: an under-recognized symptom. Aging Health, 2009;5,(5):619-624. Kristofferzon ML, Johansson I, Brännström M, Arenhall E, Baigi A Brunt D, Fridlund B, Nilsson U, Persson S, Rask M, Wieslander I, Ivarsson B and the SAMMI-study group. Evaluation of a Swedish version of the Watts Sexual Function Questionnaire (WSFQ) in persons with heart disease: A pilot study. European Journal of Cardiovascular Nursing 2010;9(3):168-174 Brännström M, Forssell A, Pettersson B. Physicians' experiences of palliative care for heart failure patients. European Journal of Cardiovascular Nursing, 2011;10(1):64-69.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No